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Reported trial results for Type 1 Diabetes

Every Type 1 Diabetes trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

280 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

NCT03263494 · results posted 9 July 2026

According to the results reported on ClinicalTrials.gov, this trial involved 153 adults who were split into two groups: 74 people used a Continuous Glucose Monitor (CGM) — a small wearable sensor that tracks blood sugar levels automatically throughout the day — and 79 people used a standard Blood Glucose Monitor (BGM), which requires a finger-prick test. The trial was measuring changes in a blood test called HbA1c over 26 weeks. HbA1c is a measure of average blood sugar levels over roughly the past three months, expressed as a percentage. All 153 participants completed the study with no dropouts reported. The reported data shows that, after adjusting for where each person started, the CGM group's HbA1c level fell by an average of 0.4 percentage points over 26 weeks, while the BGM group's rose by an average of 0.1 percentage points. Looking at secondary measures, 8% of the CGM group and 6% of the BGM group reached an HbA1c below 7.0%, and 18% of the CGM group compared with 11% of the BGM group reached below 7.5%. When looking at how many people had a meaningful drop in their HbA1c, 44% of the CGM group versus 21% of the BGM group recorded a fall of at least 0.5 percentage points, and 25% versus 6% recorded a fall of at least 1 full percentage point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT05144802 · results posted 17 June 2026

According to the results reported on ClinicalTrials.gov, this trial involved 30 people in total — 15 in Group 1 and 15 in Group 2. All 30 participants completed the study with no drop-outs. The trial was measuring how accurately a continuous glucose monitor (CGM) — a small wearable device that tracks blood sugar levels — compared to blood sugar readings taken from a vein (considered the standard reference method). The main measurement used to assess this accuracy was something called the Mean Absolute Relative Difference, or MARD, which is essentially the average percentage gap between what the CGM showed and what the venous blood test showed. A smaller percentage means the CGM reading was closer to the reference measurement. The reported data shows the MARD results were broken down across two participant groups: healthy volunteers and people with diabetes. Because the numbers were spread in an uneven way, the results are presented as a median (the middle value when all results are lined up in order) along with an IQR (interquartile range — the spread covering the middle half of results). For healthy volunteers, the reported median MARD figures were 21.2% and 41.8% across two separate measurements or devices. For participants with diabetes, the reported median MARD figures were 11.8% and 17.5% across those same two measurements or devices. No further breakdown of the IQR values was included in the submitted data. It is worth noting that the trial description itself flags that the MARD figures for healthy volunteers were notably higher than those for participants with diabetes, though no explanation for this is provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT06728059 · results posted 28 May 2026

According to the results reported on ClinicalTrials.gov, this trial involved 15 people in total — 8 in one group and 7 in the other. It was a crossover study, meaning both groups used two different versions of an automated insulin delivery system (called AIDANET, and AIDANET with an added feature called BPS-RL) at different points in time. The trial measured how well each system kept blood sugar levels within a target range (70–180 mg/dL), using a continuous glucose monitor (CGM) — a small device that tracks blood sugar automatically. Measurements were taken both during supervised overnight hotel sessions and during a week of everyday use at home. All 15 participants completed every stage of the trial. The reported data shows that during the supervised 18-hour hotel sessions, participants spent 85.7% of the time within the target blood sugar range while using AIDANET with the BPS-RL feature, and 86.5% of the time while using AIDANET alone. For time spent with blood sugar dropping below 70 mg/dL (considered low), the reported figure was 0% for both systems during the hotel sessions. During the at-home week, the reported data shows participants spent 71.7% of the time in range while using AIDANET in week one, rising to 77.0% in the second week when using AIDANET with BPS-RL. Time spent below 70 mg/dL at home was reported as 2.3% for week one and 2.2% for week two. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗
NCT05571293 · results posted 22 May 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people across three groups (called cohorts): 12 in Cohort A, 13 in Cohort B, and 1 in Cohort C. The trial was looking at how colon cancer tumours responded to immunotherapy drugs — botensilimab and balstilimab — given before surgery, by examining the removed tissue afterwards. It was also measuring whether serious side effects occurred, whether treatment caused surgery to be delayed, and tracking a blood-based marker called circulating tumour DNA (ctDNA), which can indicate whether tiny amounts of cancer remain in the body. The reported data shows that in Cohort A (which received both drugs), 7 out of 12 participants showed a pathological overall response — meaning when their tumour tissue was examined after surgery, it showed meaningful signs of regression. In Cohort B, 8 out of 13 participants showed a similar response. The single participant in Cohort C was reported to have achieved a complete or major response (100% rate, though this is based on just one person). Regarding serious side effects in Cohort A, the reported data shows 2 out of 12 participants experienced a potentially treatment-related serious adverse event within 90 days of their last dose. No participants in Cohort A had their surgery delayed by 12 weeks or more due to treatment-related complications. For the ctDNA blood marker, the reported data shows levels fell to zero in all three cohorts by 30 days after surgery, having started at varying levels before surgery. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03895437 · results posted 20 May 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT03895437) enrolled 78 people in total — 51 received an investigational treatment called TOL-3021, and 27 received a placebo (an inactive substitute used for comparison). The trial was measuring whether TOL-3021 had any effect on the body's remaining ability to produce insulin, in people living with type 1 diabetes. The main thing being tracked was a substance called C-peptide, which is a marker of the body's own insulin production, measured via a standardised meal test at 12, 16, and 24 weeks. It is worth noting that the trial records show zero participants in either group were recorded as having "completed" the study, though the reason for this is not explained in the submitted data. The reported data shows that, for the primary measure — change in C-peptide levels from the start of the trial — both groups showed very small declines at each time point. In the TOL-3021 group, the reported changes were −0.04, −0.02, and −0.06 (in log units) at weeks 12, 16, and 24 respectively. In the placebo group, the corresponding figures were −0.03, −0.02, and −0.05. For the secondary measures, the reported data shows the proportion of time blood glucose readings dropped below low-level thresholds was broadly similar between the two groups across all time periods. Daily insulin use changed by small amounts in both groups, and HbA1c (a measure of average blood sugar levels over roughly three months) showed slight changes in both groups, with the placebo group recording small decreases (around −0.2 to −0.3 percentage points) and the TOL-3021 group staying roughly flat or slightly rising. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04291703 · results posted 7 May 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT04291703) enrolled a very small number of participants — just one person in the Antithymocyte Globulin (ATG) group and one person in the Placebo group, for a total of two participants. The trial was measuring how long it took for people at an early stage of type 1 diabetes (Stage 2) to progress to a more advanced stage (Stage 3), where blood sugar levels become noticeably abnormal and a formal diabetes diagnosis is made. Both participants completed the study. The reported data shows that the single participant who received ATG took 16 days from the start of the trial to reach Stage 3 diabetes, while the single participant who received the placebo (an inactive treatment) took 87 days to reach the same point. These are the only two numbers reported for the primary outcome. Because only one person was in each group, these figures represent individual experiences rather than a broader pattern, and no other outcome measures were reported in the submitted data. It is worth noting that a trial of just two people is extremely small, and the results as submitted do not include any additional detail about why the trial was so limited in size. No secondary outcome data was reported in the structured results available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05418699 · results posted 12 March 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 410 adults with Type 1 diabetes. All 410 participants were still involved at the 3-month mark, 406 remained at 6 months, 401 at 12 months, and 391 completed the full study, with 19 people not completing it. The trial was tracking two main things: HbA1c levels — a blood test that reflects average blood sugar control over roughly 2–3 months — and "time in range," meaning the proportion of time a person's blood sugar stayed within a target zone (between 70 and 180 mg/dL). The reported data shows that the primary outcome — HbA1c measured at one point during the study — was 6.9%. For context, the trial notes that a typical non-diabetic range for this measure is between 4% and 5.6%. The reported data also shows secondary HbA1c readings of 7.0% at two other time points. Regarding time in range, the reported figures across three separate measurement points were 75%, 74%, and 74%, meaning participants' blood sugar levels were within the target zone for roughly three-quarters of the time during those measurement windows. It is worth noting that this trial had only one group — all participants received the same intervention — so there is no comparison group reported in the data. The results therefore describe what was measured across the group as a whole, without a direct comparison to a control or placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗
NCT05413239 · results posted 12 March 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 191 young people with type 1 diabetes — 95 in the intervention group and 96 in the control group. By the end of the 12-month study, 86 and 85 participants respectively had completed it. The trial was measuring how much time participants' blood sugar levels spent within a healthy target range (between 70 and 180 mg/dL), using a continuous glucose monitor (a small wearable sensor that tracks blood sugar throughout the day). It also tracked a blood test called HbA1c (a measure of average blood sugar over roughly three months), feelings of stress related to managing diabetes, and attitudes toward using diabetes devices. The reported data shows that, at the start of the study, both groups spent a similar proportion of time with blood sugar in the target range — around 50% for the intervention group and 47% for the control group. By 12 months, the intervention group's reported figure had risen to approximately 56%, while the control group's figure was around 53%. For the HbA1c blood test, the intervention group started at 7.9% and ended at 7.6%, while the control group started at 8.1% and ended at 7.9%. For diabetes-related distress (measured on a scale of 0–100, where higher means more distress), both groups reported some reduction over time — the intervention group moved from about 46 to 41, and the control group from about 52 to 47. Scores on the device satisfaction and attitudes surveys remained broadly similar across both groups throughout the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05508061 · results posted 17 February 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants in total — 5 in one group and 7 in the other — and all 12 completed the study with no dropouts. It was a crossover trial, meaning each participant used both insulin types (Lyumjev and Humalog, which are both forms of insulin lispro) at different times, so the same people contributed data to both treatment periods. The main thing the trial set out to measure was how much time participants spent with blood glucose levels above 10 mmol/L (a level considered above the healthy target range). The reported data shows that during the Lyumjev period, participants in the first sequence group spent an average of 17.2% of their time with glucose above 10 mmol/L, while during the Humalog period that figure was 16.2%. Note that results for the second sequence group (Humalog-Lyumjev) were not reported in the submitted data for this outcome. For the secondary outcomes, the reported data shows that time spent with glucose in the target range (3.9–10 mmol/L) was 81.7% for the Lyumjev period and 83.4% for the Humalog period. Time spent with glucose below 3.9 mmol/L (lower than the target range) was 1.11% for Lyumjev and 0.49% for Humalog. The average glucose reading was 7.8 mmol/L in both periods. Regarding reported side effects, 5 were recorded with Lyumjev and 1 with Humalog, though the nature of those side effects was not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05431686 · results posted 22 December 2025

According to the results reported on ClinicalTrials.gov, this trial looked at whether a type of group medical appointment — called a Shared Medical Appointment (SMA) — was a practical and acceptable way to support young people managing diabetes with a continuous glucose monitor (CGM, a small wearable device that tracks blood sugar levels throughout the day). Fourteen participants were enrolled in the single study arm, though only 4 completed the study and 10 did not complete it. The trial was measuring several things related to feasibility — that is, whether running this kind of program was realistic — including how many eligible people agreed to join, how consistently participants wore their CGM, how often they attended the group sessions, and how satisfied they were with the program. The reported data shows that 14 participants agreed to take part out of those who were approached and eligible, meeting the study's pre-set target of more than 60%. For CGM use, participants wore their device for an average of 87.5% of the 14-day monitoring periods tracked, and participants attended 90% of the scheduled group sessions on average — both above the study's target of more than 80%. The reported data also shows that 2 participants took part in in-depth interviews about their experience with the program. However, the data for two other primary outcome measures — survey results on how useful and how beneficial participants found the program content — were not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03534193 · results posted 17 December 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03534193) involved 28 people who had recently been diagnosed with Type 1 diabetes. They were split into two groups of 14: one group received standard diabetes education only, and the other received standard diabetes education plus a tablet-based education program. The trial was measuring whether adding a tablet-based learning tool made a difference in diabetes knowledge, blood sugar control, and the number of low blood sugar episodes. By the end of the study, 13 people completed the standard education group and 11 completed the tablet group. The reported data shows that on a diabetes knowledge test (scored out of 100%), the standard education group scored an average of 83%, while the tablet education group scored an average of 86%. For a blood marker called HbA1c — which gives an indication of average blood sugar levels over a period of time — both groups returned very similar figures, with the standard education group at 8% and the tablet group at 8.06%. Regarding low blood sugar episodes (called hypoglycaemic episodes) recorded before the first follow-up visit, the standard education group reported an average of 4.2 episodes, while the tablet group reported an average of 1 episode. A fourth measurement — daily blood glucose monitoring compliance — was listed as an outcome but no data was reported for it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04118374 · results posted 28 October 2025

According to the results reported on ClinicalTrials.gov, this trial involved 12 adults in total, split into two groups of six. It was a crossover study, meaning every participant tried both diets — a standard carbohydrate diet and a low carbohydrate diet — each for one week, with a three-week break in between. The trial was measuring insulin sensitivity, which is how well the body responds to insulin to manage blood sugar levels. This was tested using a specialised procedure called a hyperinsulinemic-euglycemic clamp, which carefully controls blood sugar while measuring how much glucose (sugar) the body needs to stay balanced. All 12 participants completed every stage of the trial with no drop-outs reported. The reported data shows that after one week on the standard carbohydrate diet, participants had an average glucose infusion rate — the amount of sugar needed to keep blood sugar stable during the test, used here as a measure of insulin sensitivity — of 8.6 mg/kg FFM/min. After one week on the low carbohydrate diet, the reported average was 8.1 mg/kg FFM/min. The results as submitted indicate no significant difference between the two diets on this measure. Only this one primary outcome measure was reported in the structured results data; no secondary outcome measure figures were included in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT05992350 · results posted 20 October 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 45 participants across two groups — 24 in the "Primary Analysis Arm" and 21 in the "Parent Arm." The study was measuring several things related to type 1 diabetes management, including how much moderate-to-vigorous physical activity participants did each day, how often they were hospitalised for a serious diabetes complication called diabetic ketoacidosis (a dangerous build-up of acids in the blood), how much time their blood sugar levels stayed within a healthy range, and whether machine learning (computer-based prediction tools) could forecast changes in these health measures. The reported data shows that, of the 45 people who started the trial, only 3 participants (all from the Primary Analysis Arm) were recorded as having completed it, while the remaining 42 were listed as not completing the study. Regarding the actual outcome measurements — the physical activity minutes, hospitalisation rates, blood sugar time-in-range figures, and machine learning predictions — no numerical results were included in the data submitted to ClinicalTrials.gov. Because those figures were not reported in the structured results, it is not possible to describe what the trial found for any of these measures. The reported data shows that the absence of results for all primary outcome measures means there is currently no publicly available numerical information from this trial about physical activity levels, diabetic ketoacidosis rates, blood sugar control, or the performance of the prediction models. This may be because the trial did not reach full completion, though the reason is not stated in the available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04955691 · results posted 16 October 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people in total, split into two groups of 9 and 10. It used a "crossover" design, meaning everyone tried both diets — a low carbohydrate diet and a standard carbohydrate diet — one after the other, with a break (washout period) in between. The trial was measuring how blood sugar levels behaved during each diet, using a continuous glucose monitor worn over two weeks at a time. All 19 participants started and were analysed, though three did not complete the final phase. The reported data shows that the main thing being measured was the percentage of time participants' blood sugar stayed within a target range of 70–180 mg/dL (considered an "optimal" range for blood sugar). During the low carbohydrate diet, participants spent an average of 71.20% of the time in that range, compared with 62.51% during the standard carbohydrate diet. The reported data also shows figures for time spent with low blood sugar (hypoglycaemia) and high blood sugar (hyperglycaemia). For very low blood sugar (below 54 mg/dL), the reported percentages were 0.42% on the low carbohydrate diet and 0.33% on the standard diet; for mildly low blood sugar (54–69 mg/dL), the figures were 1.27% and 1.46% respectively. For mildly high blood sugar (181–250 mg/dL), the reported figures were 19.93% on the low carbohydrate diet and 23.20% on the standard diet; for very high blood sugar (above 250 mg/dL), the figures were 7.19% and 12.50% respectively. A separate part of the trial also planned to gather participant feedback through interviews about their experience following a very low carbohydrate diet, though no numerical results from that component were reported in this data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04016415 · results posted 2 October 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04016415) enrolled 309 adults with diabetes — 154 assigned to a Mindfulness-Based Stress Reduction (MBSR) program and 155 assigned to a Stress Management Education (SME) program. The trial was measuring whether a mindfulness program, compared to a general stress education program, would change participants' blood sugar control (using a home HbA1c test — a measure of average blood sugar levels over roughly three months), their diabetes-related distress, and their general feelings of stress, at two months and six months after starting. The reported data shows the following for blood sugar (HbA1c, where lower numbers mean lower average blood sugar): the MBSR group started at an average of 8.50% and the SME group at 8.60%. By six months, the reported model-based estimates showed the MBSR group dropped by 0.35 percentage points and the SME group by 0.36 percentage points. At two months, the drops were 0.23 points (MBSR) and 0.30 points (SME). For diabetes-related distress (scored 1–6, higher meaning more distress), both groups started around 2.3–2.5 and both showed small reductions at two and six months, with changes ranging from about −0.26 to −0.39 across groups. For general perceived stress (scored 0–40, higher meaning more stress), the MBSR group started at roughly 19.85 and the SME group at 18.18; by two months the reported reductions were 3.20 points (MBSR) and 1.63 points (SME), and by six months, 2.81 points (MBSR) and 1.98 points (SME). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03406897 · results posted 17 September 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 27 people in total — 12 in a group receiving a combination of omega-3 and vitamin D, and 15 in a group receiving vitamin D only. The trial was looking at whether these supplements might affect the body's remaining ability to produce its own insulin in people with type 1 diabetes, measured using a special test called a Mixed Meal Tolerance Test (MMTT), which involves a meal-like drink and a blood test 90 minutes later to check a substance called C-peptide (a marker of the body's own insulin production). Not everyone finished the trial — 7 people completed it in the omega-3 and vitamin D group, and 8 in the vitamin D only group. The reported data shows that, after one year, both groups had lower C-peptide levels than when they started. The omega-3 and vitamin D combination group showed a change of −1.23 ng/mL (a decrease), while the vitamin D only group showed a change of −0.62 ng/mL (also a decrease, but a smaller one). For the secondary measures, the reported data shows that a blood sugar control marker called HbA1c (a percentage that reflects average blood sugar over roughly three months) changed by 0.00 percentage points in the combination group and −0.55 percentage points in the vitamin D only group. Insulin requirements (the amount of insulin needed per kilogram of body weight per day) rose slightly in both groups — by 0.16 units/kg/day in the combination group and 0.15 units/kg/day in the vitamin D only group. The number of recorded adverse events (unexpected medical occurrences noted during the trial) was 31 in the combination group and 28 in the vitamin D only group; no further detail about the nature of these events was included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT06017089 · results posted 15 September 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT06017089) enrolled 32 adults who used an AI-guided, at-home "closed loop" insulin delivery system — a type of automated insulin pump that adjusts doses based on continuous glucose readings. Of the 32 who started, 28 completed the trial. The study compared participants' glucose readings during a baseline period (before the AI system was active) against their readings while using the AI-guided system. The reported data shows the following glucose measurements, captured by a continuous glucose monitor (a small sensor worn on the body that tracks blood sugar levels around the clock). During the baseline period, participants spent 63% of their time with glucose in the target range of 70–180 mg/dL; during the AI-guided period this figure was reported as 70%. Average glucose levels were reported as 168 mg/dL at baseline and 157 mg/dL during the AI-guided period. Time spent with glucose above 250 mg/dL (a high level) was 13% at baseline and 9% during the AI-guided period. Time spent below 70 mg/dL (a low level) was 2% at baseline and 1.7% during the AI-guided period. For the very low glucose threshold (below 54 mg/dL), both the baseline and AI-guided periods were reported at 0.3%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03608163 · results posted 11 September 2025

According to the results reported on ClinicalTrials.gov, this trial involved just 4 participants in total, split into two groups of 2. It used a "crossover" design, meaning each person received both naloxone (a medication) and a placebo (an inactive substitute) at different times, with a washout period of roughly 6 months in between. The trial was measuring whether naloxone could affect the body's hormonal and physical responses during episodes of low blood sugar (hypoglycaemia) that were deliberately and safely induced in a controlled clinical setting. The reported data shows the following numbers. For the main outcome — peak levels of a stress hormone called epinephrine (adrenaline), measured in the blood during low blood sugar episodes — the naloxone group recorded average peak levels of 372 and 397 pg/mL (picograms per millilitre, a unit of concentration) across the two measurement points, while the placebo group recorded 707 and 601 pg/mL. For one secondary outcome measuring the body's own sugar production (reported as a glucose infusion rate in cc/min), the naloxone group returned values of 1.6 and 0.9, compared with 0.7 and 1.1 for the placebo group. For the other secondary outcome — self-reported symptoms of low blood sugar, scored on a scale from 0 to 77 where higher means more intense symptoms — the naloxone group scored 2.0 and 1.2, while the placebo group scored 4.5 and 4.2. It is important to note that with only 4 participants, this was a very small study, and the reported results should be understood in that context. The trial appears to have been a preliminary investigation rather than a large-scale test of the treatment. No conclusions about whether naloxone "works" for this purpose can be drawn from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04385888 · results posted 26 August 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04385888) looked at whether reducing low-calorie sweetener consumption made a difference to blood sugar patterns and a few other body measurements in children and their parents. A total of 62 people started the initial run-in phase (31 children and 31 parents across both groups), and after that phase, 28 children and 28 parents were randomly placed into either a "low-calorie sweetener restriction" group or a "usual consumption" control group. By the end of the trial, 13 children and 13 parents completed each group. The reported data shows that the main thing being measured was "time in range" — that is, the proportion of time a person's blood sugar levels stayed within a healthy target zone, tracked using a continuous glucose monitor. The reported change in this measure was 2.00 percentage points for the restriction group and 3.91 percentage points for the control group. For the secondary measurements, the reported change in visceral fat (fat stored around internal organs, measured by a body scan) was 0.1% body fat in the restriction group and 1.0% in the control group — though the researchers noted that very few participants were able to complete both pre- and post-intervention scans due to COVID-19 disruptions, so this data is limited. The reported change in a blood marker called TNF-alpha (a substance linked to inflammation) was +0.08 pg/mL in the restriction group and −0.23 pg/mL in the control group. No outcome data was reported separately for parents in any of these measures. It is worth noting that the trial was small in size, and some data collection was affected by COVID-19, which the researchers themselves acknowledged. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT06018844 · results posted 19 August 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 1 participant in a single group called the "Primary Arm." The study was designed to look at how a text message-based tool called the "NUDGE bot" might interact with young people, and to measure their levels of moderate to vigorous physical activity (that is, exercise intense enough to raise the heart rate noticeably). It also tracked a number of secondary measures, including how consistently participants wore a physical activity monitoring device (called an Actigraph), how often they completed daily physical activity schedules, and changes in a blood marker called HbA1c (a measure of average blood sugar levels over time). The reported data shows that of the 1 participant who started the trial, none completed it. Because the trial did not reach completion, no numerical results were reported for any of the outcome measures — not for the text message exchanges with the NUDGE bot, not for physical activity levels, and not for any of the secondary measures including the HbA1c results. All measurement fields in the submitted data were empty. In summary, the trial was not able to generate any results data, as it began and ended with a single participant who did not finish the study. No conclusions about any of the measures being studied can be drawn from this submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03638141 · results posted 17 August 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 21 people who received a combination of two immunotherapy drugs — durvalumab and tremelimumab. Twenty of those participants completed the study, and one did not. The trial was measuring how the combination affected a type of liver cancer, looking mainly at how many patients' tumours shrank or disappeared, and also tracking how long participants lived without their disease getting worse, how long they survived overall, and what serious side effects occurred. The reported data shows that out of 21 participants, 11 had their tumours either disappear completely or shrink by a meaningful amount (at least 30%) according to a standard imaging measurement system called mRECIST — this is what the trial called the "objective response rate." For the time-related measures, the reported data shows a median of 6.1 months before participants' disease progressed or they passed away (known as progression-free survival), and a median overall survival of 28.8 months — meaning that half of participants lived longer than this and half did not. A median is simply the middle value when results are lined up from lowest to highest. Regarding serious side effects, the reported data shows that 4 participants experienced drug-related unwanted effects rated as severe (Grade 3 or higher), along with several individual events each occurring in 1–2 participants, though the specific nature of each event was not fully detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05537233 · results posted 12 August 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 72 adults with type 1 diabetes — 36 in the semaglutide group and 36 in the control (placebo) group. The trial ran for 26 weeks and was measuring whether semaglutide, compared to placebo, could help participants reach a combined ("composite") goal: spending more than 70% of the day with blood sugar in a healthy range, spending less than 4% of the day with blood sugar too low, and losing at least 5% of their body weight — all tracked using a continuous glucose monitor (a small wearable device that reads blood sugar levels throughout the day). By the end of the study, 34 of the 36 semaglutide participants and 33 of the 36 control participants completed the trial. The reported data shows that 13 out of 36 participants in the semaglutide group met all three parts of that combined goal at 26 weeks, compared to 0 out of 36 in the control group. For the secondary (additional) measures, the semaglutide group showed an average reduction in HbA1c (a blood test reflecting average blood sugar over roughly three months) of 0.7 percentage points, versus 0.4 in the control group. Average blood sugar levels (measured by the continuous monitor) fell by 15.7 mg/dL in the semaglutide group compared to 3.6 mg/dL in the control group. The proportion of time spent in a tighter healthy range (70–140 mg/dL) increased by 9.8 percentage points in the semaglutide group versus 2.9 in the control group. Time spent with blood sugar above 180 mg/dL decreased by 11.1 percentage points (semaglutide) versus 2.7 (control), and time above 250 mg/dL decreased by 5.1 percentage points (semaglutide) versus 0.5 (control). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02213003 · results posted 12 August 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT02213003) involved **3 people** who all received islet transplantation — a procedure where insulin-producing cells are transplanted into the body, in this case into a fold of tissue in the abdomen called the omentum. All 3 participants completed the study. The trial was measuring two main things: first, whether participants reached a certain blood sugar control level (a measure called HbA1c at or below 6.5%) without experiencing serious low blood sugar episodes; and second, whether participants had any complications related to the procedure itself. The reported data shows that approximately **2 out of 3 participants** (a proportion of 0.667, meaning roughly two-thirds) met the blood sugar target and did not have any serious low blood sugar episodes during the study period. Regarding procedural complications — which the trial defined as problems such as bleeding, wound infection, hernia, twisting of the omentum tissue, bowel blockage, abscess, cysts, or the need for further surgery — the reported data shows that all **3 out of 3 participants** experienced at least one of these complications. No further breakdown of the types or severity of individual complications was reported in the data submitted to ClinicalTrials.gov. It is worth noting that this was a very small study with only 3 participants, so the numbers reflect a very limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04404556 · results posted 15 July 2025

According to the results reported on ClinicalTrials.gov, this trial involved 162 young people with Type 1 diabetes, split into two groups: 97 in the "Diabetes Journey" group and 65 in the "Enhanced Standard of Care" group. The trial was measuring how much of a barrier diabetes management felt to participants — specifically around stress and burnout, and around the time and planning demands of managing diabetes day-to-day. Participants were followed across several stages: during the program, immediately after, and at two further follow-up points. The reported data shows that for the stress and burnout measure (scored from 1 to 5, where higher means feeling more burdened), the Diabetes Journey group scored 2.36 and the Enhanced Standard of Care group scored 2.31. For the time and planning measure (also 1 to 5, same direction), the Diabetes Journey group scored 1.92 and the Enhanced Standard of Care group scored 2.03. For the secondary outcomes, a blood sugar measure called HbA1c — which reflects average blood sugar levels over roughly two to three months — was reported as 8.06% for the Diabetes Journey group and 7.98% for the Enhanced Standard of Care group. Quality of life scores (on a scale of 0 to 100, where higher means better) were almost identical: 65.84 for the Diabetes Journey group and 65.82 for the Enhanced Standard of Care group. Two other secondary measures — time spent in a healthy blood sugar range (for those using continuous glucose monitors) and the number of daily blood sugar checks — were listed but no results data was reported for these outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05916131 · results posted 18 June 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people across four groups: one group received Hypoglycemia Symptom Detection Training, one received an approach called Education Plus, one received both of those interventions combined, and one received usual care. The trial was primarily designed to test whether running the study was practical — specifically, whether the researchers could recruit enough people to reach a target of 20 participants completing the 12-week intervention period. It was not designed at this stage to test whether any particular treatment worked better than another. The reported data shows that 227 potential candidates were contacted during the recruitment period. Of those who were assessed for eligibility, 35.1% were found to meet the criteria to take part. The primary goal — recruiting enough people so that 20 completed the intervention — was met, with 20 participants recorded as having done so. Looking at how many people stayed in the study over time, the reported data shows that at the 12-week mark, all 40 participants who started were still taking part (9, 10, 11, and 10 across the four groups respectively). At both the 26-week and 52-week follow-up points, 39 of the original 40 remained, with one participant in the combined-treatment group not completing those later visits. No data on clinical outcomes (such as blood sugar levels or symptom changes) was reported in this submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03013491 · results posted 17 June 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03013491) tested an investigational drug called CX-072, either on its own or combined with other drugs (ipilimumab or vemurafenib), in people with advanced cancer. The trial was split into several parts testing different doses, and a total of 196 participants took part across all groups. The main thing the trial was set up to measure was how many participants at each dose level experienced what are called "dose-limiting toxicities" (DLTs) — that is, serious side effects considered severe enough to potentially limit how much of the drug could be given. A secondary measure looked at how many participants showed a reduction in their cancer (known as an "objective response rate" or ORR), meaning their tumour either disappeared completely or shrank significantly on two consecutive scans. The reported data shows that, for the primary measure, DLTs were recorded in a small number of participants across certain dose groups. Specifically: 1 participant in the CX-072 1 mg/kg alone group, 1 participant in the CX-072 3 mg/kg alone group, 1 participant in the CX-072 0.3 mg/kg combined with ipilimumab 3 mg/kg group, and 2 participants in the CX-072 10 mg/kg combined with ipilimumab 6 mg/kg group experienced a DLT. No DLTs were reported for the remaining dose groups listed. For the secondary measure looking at anti-cancer activity, the reported data shows that 1 out of 16 participants in the CX-072 10 mg/kg monotherapy group (Part A) and 13 out of 98 participants in the CX-072 10 mg/kg monotherapy group (Part D) met the criteria for a response. Data for some of the other groups and outcome measures was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04848480 · results posted 12 June 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 582 adults in total — 290 in a group taking a once-weekly insulin called insulin icodec (combined with a mealtime insulin called insulin aspart), and 292 in a group taking a once-daily insulin called insulin degludec (also combined with insulin aspart). The trial ran for 52 weeks in two back-to-back phases of 26 weeks each. It was primarily measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly three months — between the start of the trial and week 26. The reported data shows that, at week 26, average HbA1c fell by 0.47 percentage points in the icodec group and by 0.51 percentage points in the degludec group. By week 52, the reported change from the starting point was 0.37 percentage points in the icodec group and 0.54 percentage points in the degludec group. For fasting blood sugar levels (measured at week 26), the icodec group showed an average fall of 0.84 mmol/L, while the degludec group showed an average fall of 1.87 mmol/L. Continuous glucose monitoring data (collected between weeks 22 and 26) showed that participants in the icodec group spent about 59% of the time with blood sugar in the target range, compared with about 61% for the degludec group. A treatment satisfaction questionnaire (scored 0–36, with higher meaning more satisfied) showed an average increase of about 2.0 points in the icodec group and 3.1 points in the degludec group from the start of the trial. The reported data also includes a count of severe low blood sugar episodes — defined as episodes so serious that the person needed help from someone else to recover. Between the start of the trial and week 26, there were 47 such episodes recorded across all participants in the icodec group, compared with 17 in the degludec group. These are raw episode counts across all participants in each group, not rates per person, and no further breakdown was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02218619 · results posted 5 June 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total — 10 received a substance called TUDCA (taurourodeoxycholic acid, a bile acid compound) and 10 received a sugar pill (placebo). All 20 participants completed the trial. The main thing the trial was measuring was how well the insulin-producing cells in the pancreas were still working over time, using a marker called C-peptide (a substance released alongside insulin). Participants drank a mixed meal and had their C-peptide levels tracked; a higher score means more insulin-producing activity. The measurements were taken at 6, 12, and 18 months. The reported data shows that C-peptide levels declined in both groups over the course of the trial. At 6 months, both the TUDCA group and the placebo group showed the same reported change from their starting point (−0.07 nmol/L×120 min). At 12 months, the placebo group showed a change of −0.10 and the TUDCA group −0.12. At 18 months, the placebo group showed −0.11 and the TUDCA group −0.14. Regarding insulin use (the amount of insulin injected per kilogram of body weight), the reported data shows the placebo group had a change of −0.10 units/kg at both 6 and 12 months, while the TUDCA group showed a change of +0.09 units/kg at both time points. For liver function tests — checked to monitor for any abnormalities in liver blood results — the reported data shows zero participants in either group had results outside the normal range at any of the three testing points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT06546657 · results posted 19 March 2025

According to the results reported on ClinicalTrials.gov, 89 people took part in this trial, which used a small wearable device called a continuous glucose monitor (CGM) to track blood sugar levels throughout the day. The trial was looking at what happens to blood sugar in the hours after eating breakfast. A total of 387 breakfast meals were tracked across the group, and 74 participants also completed questionnaires about their breakfast and how they felt after eating (71 finished that part of the study). The reported data shows that the average blood sugar level measured over the four hours after breakfast was 9.2 mmol/L. The average "excursion" — meaning how much blood sugar rose above the starting level at the beginning of the meal — was 1.4 mmol/L across 381 meals. The highest single rise above the starting level (called the peak excursion) was reported as 4.9 mmol/L on average, and that peak typically occurred around 124 minutes (just over two hours) after the meal began. The reported data also shows a measure called "area under the curve" — which captures the overall amount of time blood sugar stayed elevated across the four hours — was 500 (mmol/L)×minutes. Finally, a figure called the "coefficient of variation" (a measure of how much blood sugar levels fluctuated up and down) was reported as 23.3% across the breakfast meals tracked. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05698875 · results posted 11 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05698875) enrolled 26 participants, all in a single group called "Breakfast Meals." The trial was measuring how blood sugar levels responded in the three hours after eating different breakfast meals. Participants were given four different meals to try: a high glycaemic load meal (HGL), a high glycaemic load meal with extra protein (HGLP), a medium glycaemic load meal (MGL), and a control meal. Blood sugar was tracked using a continuous glucose monitor (a small sensor worn on the body that records readings every five minutes). Twenty-five participants completed the trial and one did not. The reported data shows the following results across the four meals (HGL, HGLP, MGL, and Control, in that order). For average blood sugar level over the three hours, the reported figures were 9.5, 8.0, 8.7, and 8.4 mmol/L. For the average rise in blood sugar above the starting level, the figures were 2.8, 1.3, 1.9, and 2.1 mmol/L. The highest single blood sugar spike recorded was 6.4, 4.2, 4.5, and 4.6 mmol/L respectively. The time it took to reach that peak was 72, 58, 96, and 81 minutes. The total "area under the curve" — a way of capturing how high and how long blood sugar was elevated — was reported as 579, 325, 408, and 440 units. Finally, blood sugar variability (how much readings fluctuated) was 26.4%, 23.0%, 19.8%, and 19.7% for each meal in the same order. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03436992 · results posted 17 February 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03436992) involved 57 participants in total — 32 women with Type 1 diabetes (referred to as "T1M Women") and 25 people without diabetes who acted as a comparison group ("Controls"). All 57 participants completed the study with no dropouts recorded. The trial was measuring something called Flow-Mediated Dilation (FMD), which is a way of assessing how well blood vessels widen in response to increased blood flow. To make this measurement more accurate, the FMD readings were adjusted to account for the amount of blood flow stimulus (called "shear"), giving a combined figure expressed as a percentage per unit of blood flow. The reported data shows two sets of FMD/shear readings for each group, which likely reflect measurements taken at two different time points or under two different conditions, though the data as submitted does not label these separately. For the T1M Women group, the reported figures were 0.182 and 0.155 (in units of %/s⁻¹). For the Controls group, the reported figures were 0.206 and 0.219 (in the same units). In both sets of readings, the Controls group recorded higher numbers than the T1M Women group. No secondary outcome measure data was included in the submitted results. Any further detail about what these differences mean clinically was not reported in the structured data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05714059 · results posted 17 February 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 222 people in total — 112 aged 7 to 17 years, and 110 aged 18 to 80 years. The study ran for three months and was looking at how a diabetes management approach affected blood sugar control. The main things being measured were changes in a blood sugar marker called HbA1c (a number that reflects average blood sugar levels over roughly three months), and how much time participants spent with their blood sugar in a target range of 70–180 mg/dL. Most participants completed the study — 107 in the younger group and 105 in the older group, with five in each group not finishing. The reported data shows that, on average, HbA1c levels fell by 0.4 percentage points in the 7–17 age group, and by 0.7 percentage points in the 18–80 age group over the three months. For time spent within the target blood sugar range, the reported data shows an average of 71.4% of the time for the younger group and 80.2% for the older group. The trial also measured how much time participants spent with very low blood sugar (below 54 mg/dL), which was reported as an average of 0.4% of the time for the younger group and 0.2% for the older group. These time-in-range figures were reported under both the primary and secondary outcome measures, with the same numbers appearing in both. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04270942 · results posted 12 February 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04270942) involved six people who received the study drug, teplizumab. Five of the six participants completed the trial, while one did not. The trial was primarily measuring how many participants experienced certain medical events — called adverse events — during treatment, including serious ones and those considered of special interest (such as severe infections or significant changes in blood cell counts). It also tracked several secondary measures, including how the body processed the drug, whether the immune system produced antibodies against it, and markers related to insulin production and blood sugar control. The reported data shows that all six participants experienced at least one treatment-emergent adverse event (meaning a medical occurrence that happened during or after starting the drug). One participant experienced a treatment-emergent serious adverse event. No participants experienced adverse events classified as being of special interest. Regarding the secondary measures, all six participants were found to have developed antibodies against teplizumab. At week 78 (roughly 18 months into the study), the reported average HbA1c level — a measure of blood sugar control over time — was 8.50%, and average daily insulin use was 0.54 units per kilogram of body weight per day. A measure of the body's own insulin production (called C-peptide, assessed after a meal test) returned a reported value of 0.549. The drug concentration level in the blood just before the next scheduled dose at day 364 was not reported in the data provided. It is worth noting that with only six participants, this was a very small study, and the data should be understood in that context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05325294 · results posted 15 January 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 211 people in total — 101 participants aged 7 to 17 years, and 110 participants aged 18 to 80 years. The study ran for three months and was measuring two main things: how blood sugar control changed over time (using a measure called HbA1c, which reflects average blood sugar levels over roughly three months), and how much time participants spent with their blood sugar in a target range of 70–180 mg/dL (a level considered neither too high nor too low). By the end of the study, 97 of the younger participants and 101 of the older participants had completed the trial. The reported data shows that, on average, HbA1c changed by −0.1 percentage points in the 7–17 age group and −0.4 percentage points in the 18–80 age group over the three months — meaning both groups showed a small reduction in that average blood sugar measure. For time spent in the target blood sugar range, the reported data shows the younger group averaged 68.6% of the time in range, while the older group averaged 77.6%. Two secondary (additional) measures were also reported: the percentage of time participants spent with very low blood sugar (below 54 mg/dL) averaged 0.4% for the younger group and 0.2% for the older group, and the time-in-range figures were also examined under a stricter test, with the same values of 68.6% and 77.6% recorded for the younger and older groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03163511 · results posted 3 December 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03163511) involved two groups of participants. Cohort 1 had 2 participants and Cohort 2 had 47 participants, giving a total of 49 people across the study. The trial was measuring two different things: for Cohort 1, it tracked the number of adverse events (that is, any unwanted medical occurrences) that happened during the study; and for Cohort 2, it measured a substance called C-peptide — a marker that reflects how much insulin the body is producing — to see whether levels changed over 26 weeks following a mixed meal test. The reported data shows that in Cohort 1, the adverse event counts recorded were 33, 2, 24, and 8 across different categories, though the breakdown of exactly what each of these figures refers to was not clearly separated in the submitted data. For Cohort 2, the reported data shows a change in C-peptide levels of 0.1292 ng\*hour/mL from the start of the study to week 26. It is also worth noting that of the 47 people who started in Cohort 2, only 14 completed the study, and 33 did not complete it; for Cohort 1, 1 of the 2 participants completed the study. The reasons for not completing were not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02046733 · results posted 8 November 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 153 people in total — 75 in an observation-only group and 78 in a group receiving a combination of two immunotherapy drugs, nivolumab and ipilimumab. The trial was looking at what happened after participants had already completed a standard course of chemoradiotherapy treatment. The main thing being measured was **progression-free survival** — that is, how long participants went without their disease getting worse or dying. The reported data shows that, for the primary measure of progression-free survival, the observation group went a median (middle value across all participants) of 14.5 months without disease progression, while the nivolumab plus ipilimumab group recorded a median of 10.7 months. For overall survival — how long participants lived from the time they joined the trial — the observation group had a median of 32.1 months, while a final figure for the combination treatment group was not reported in the data. Regarding how many participants had their tumour shrink or disappear (called an objective response), 8 people in the observation group and 6 in the treatment group had a complete response (no detectable tumour), while 22 and 20 respectively had a partial response (tumour shrank noticeably). The reported data also shows that adverse events (unwanted side effects of any kind) were recorded in 65 of 75 observation participants and 77 of 78 treatment participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05243628 · results posted 18 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT05243628) enrolled 28 people in total across three groups: 13 people received inhaled insulin (Afrezza) combined with an Automatic Insulin Delivery (AID) system, 10 people received Afrezza combined with a long-acting injected insulin called Insulin Degludec, and 5 people used an AID system alone as a comparison group. The trial was primarily measuring changes in a blood sugar marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly three months. It also tracked how often participants experienced episodes of low blood sugar (hypoglycaemia) at different severity levels, and how much time participants spent with their glucose levels in a target range. The reported data shows that HbA1c changed by an average of +0.32 percentage points in the Afrezza + AID group, +0.35 percentage points in the Afrezza + Insulin Degludec group, and +0.52 percentage points in the AID-only group — meaning average HbA1c increased slightly in all three groups over the course of the study. For time spent in the target glucose range (70–180 mg/dL), the Afrezza + AID group showed an average increase of 4.69 percentage points, while the Afrezza + Insulin Degludec group showed an average decrease of 3.89 percentage points, and the AID-only group showed an average increase of 1.99 percentage points. Regarding low blood sugar episodes, the reported counts for mild-to-moderate lows (below 70 mg/dL) were 12, 20, and 14 events across the three groups respectively, and for more significant lows (below 54 mg/dL) were 3, 5, and 4 events. No episodes of severe hypoglycaemia requiring another person's assistance were recorded in any group. It is worth noting that four participants in the Afrezza + AID group did not complete the trial, while all participants in the other two groups did complete it. Because the groups were quite small, these numbers should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04432090 · results posted 17 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04432090) looked at a drug called MBX-2982 and its effect on a hormone called glucagon during low blood sugar (hypoglycaemia). Glucagon is a hormone the body normally releases to help raise blood sugar when it drops too low. The trial involved people with Type 1 diabetes and healthy volunteers. A total of 110 people were assessed at the start, 36 were randomised (that is, assigned by chance to a treatment group), and 27 completed the study — 9 in each of the three groups. People with Type 1 diabetes either received MBX-2982 first then a dummy treatment (placebo), or the placebo first then MBX-2982, allowing the same people to be compared across both conditions. The reported data shows that during a controlled period of induced low blood sugar, the researchers measured glucagon levels in three ways. First, they looked at the peak (highest) glucagon level reached: for people with Type 1 diabetes taking MBX-2982 it was 19.9 pg/mL, compared with 22.5 pg/mL when those same participants were on the placebo, and 82.7 pg/mL in healthy volunteers. Second, they measured the total amount of glucagon released over a 20-minute window (expressed as an "area under the curve," meaning a combined measure of level over time): 6,624.6 units for the MBX-2982 group, 6,037.5 for the placebo group, and 15,923.2 for healthy volunteers. Third, they looked at how much glucagon rose *above* each person's own baseline: 327.9 units for MBX-2982, 467.8 for placebo, and 2,445.4 for healthy volunteers. These numbers reflect what was recorded during the study measurements only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03808376 · results posted 20 August 2024

According to the results reported on ClinicalTrials.gov, this trial looked at a continuous glucose monitoring (CGM) device called the Eversense® 180 system. A total of 181 people started the trial, 171 completed it, and 10 did not finish. A smaller subgroup of 43 participants also used an additional feature called the SBA sensor. The trial was measuring how closely the device's glucose readings matched reference (laboratory-style) glucose readings over 180 days, as well as tracking any serious unwanted events linked to the device or the procedure to insert or remove it. The reported data shows accuracy was measured using something called MARD (Mean Absolute Relative Difference) — in simple terms, this is the average percentage gap between what the device read and what the reference measurement read. A lower percentage means the device's readings were closer to the reference. For all participants, the reported MARD was 9.1%, and for the smaller SBA sensor subgroup it was 8.5%. For the safety endpoint, the reported data shows that zero serious adverse events (serious unwanted health events) that were related to the device or the insertion/removal procedure were recorded in either group over the 180-day period. It is worth noting that this trial had only one group — everyone used the Eversense® 180 CGM device — so there was no comparison group receiving a different or no treatment. The reported numbers reflect measurements taken within this single group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03058289 · results posted 13 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03058289) enrolled a total of 110 people with advanced or recurring solid tumours across nine separate groups. Some groups received the study drug INT230-6 on its own (monotherapy), while others received it in combination with either pembrolizumab or ipilimumab — two other cancer medicines. The trial was primarily measuring how often participants experienced serious unwanted reactions (called "adverse events" graded 3 or above on a 1–5 scale, where higher numbers mean more severe) that were linked to the study drug itself, rather than to their underlying illness. It also looked at things like how the disease responded to treatment and how the drug moved through the body. The reported data shows that, for the primary measure — the number of participants experiencing serious adverse events (grade 3 or higher) attributed to the study drug — the counts across groups were: 0 in Cohort A1 (6 participants), 0 in Cohort B1 (4 participants), 1 in Cohort EA (4 participants), 2 in Cohort EC (21 participants), 4 in Cohort EC-2 (20 participants), 0 in Cohort EC3 (9 participants), 1 in the first pembrolizumab combination group (6 participants), 6 in the second pembrolizumab combination group (22 participants), and 2 in the ipilimumab combination group (18 participants). For one of the secondary measures — disease control rate, meaning the percentage of participants whose disease was recorded as completely responding, partially responding, or staying stable — the reported figures were 83.3% for monotherapy participants who received higher doses, 50.0% for those who received lower doses, 64.3% for the combined pembrolizumab groups, and 83.3% for the ipilimumab combination group. The trial also tracked how the drug's three components moved through the bloodstream at various dose sizes; those blood-level measurements were reported across multiple dose volume categories, with figures varying considerably depending on the component and dose. The exploratory measure looking at non-injected tumours did not have results reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05403502 · results posted 26 July 2024

According to the results reported on ClinicalTrials.gov, 183 people with diabetes who used a Tandem t:Slim X2 insulin pump with Control-IQ 1.5 technology took part in this trial. The study was designed to measure certain safety-related events — specifically serious low blood sugar episodes (called severe hypoglycaemia), a serious complication called diabetic ketoacidosis (DKA), and any unexpected problems caused by the device. The trial had two phases: a lead-in period using one insulin (Humalog), followed by a treatment period using a different fast-acting insulin called Lyumjev in the same pump system. By the end of the study, 173 participants had completed the full trial. The reported data shows that during the Lyumjev treatment period, there were 3 reported severe hypoglycaemia events — meaning 3 occasions where a participant's blood sugar dropped so low they needed another person's help to treat it. No events of diabetic ketoacidosis requiring an overnight hospital stay were reported, and no unexpected device-related problems were recorded. The reported data also shows results from continuous glucose monitor (CGM) readings — a device that tracks blood sugar levels throughout the day. Participants spent approximately 0.26% of their time with blood sugar below a very low threshold (54 mg/dL, an extremely low level), and about 1.2% of their time below 70 mg/dL (a generally recognised low blood sugar level). Similar figures were recorded in the earlier Humalog phase for comparison. It is worth noting that because this trial had only one group — everyone used the same pump and eventually switched to Lyumjev — the reported data shows figures from each phase side by side, rather than comparing two separate groups of people. The data was not reported in a way that allows a direct before-and-after statistical comparison to be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04664205 · results posted 26 July 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04664205) involved 14 participants in total, split across three groups. It used a crossover design, meaning each person took part in all three sessions at different times: a high-intensity interval training session (short bursts of hard effort), a moderate-intensity continuous training session (steady, sustained effort), and a rest/control session. The trial was measuring how these different types of exercise affected the amount of energy burned during the workout, blood lactate levels (a chemical that builds up in the blood during harder exercise and gives a rough guide to how much carbohydrate the body is using), and blood sugar (glucose) levels after exercise and overnight. The reported data shows that during exercise, the high-intensity interval training group burned an average of 264.5 kilocalories, compared with 225.5 kilocalories for the moderate-intensity group. For blood lactate, the reported data shows two sets of readings — likely taken at different time points during exercise — with the high-intensity group recording values of 8.46 and 2.30 mmol/L, and the moderate-intensity group recording 7.11 and 1.75 mmol/L. No lactate value was reported for the control session group. For overnight blood sugar levels, the reported data shows average glucose readings (in mg/dL, a unit for measuring sugar concentration in the blood) of 155.2 for high-intensity, 146.9 for moderate-intensity, and 124.5 for the control group during one period, and 139.7, 165.6, and 150.3 respectively during another period. The data does not specify exactly which time points these two sets of readings correspond to. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02236754 · results posted 23 July 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT02236754) enrolled 23 people in total — 15 healthy volunteers (controls) and 8 people living with Type 1 diabetes (T1D). One person in the healthy volunteer group did not complete the trial, while all 8 participants with T1D finished. The trial was measuring something called VMAT2 functional binding capacity in the pancreas — a way of using a special type of medical imaging scan (PET scan) to estimate the amount of insulin-producing cells (called beta cells) in the pancreas. A higher number on this measure is meant to reflect a greater amount of those cells. The reported data shows one primary outcome was measured and compared between the two groups. The healthy volunteer group had a reported average VMAT2 binding capacity score of 103, while the group of people with longstanding Type 1 diabetes had a reported average score of 38. Both figures are reported without units, as the measure itself is calculated from a combination of factors that result in a unitless number. No secondary outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03046927 · results posted 10 July 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03046927) enrolled 36 children or young people recently diagnosed with type 1 diabetes — 18 in a group that received ergocalciferol (a form of vitamin D) and 18 in a group that received a placebo (an inactive substitute). The trial ran for 12 months and was measuring whether vitamin D supplementation had any effect on several things: how much insulin the body was still producing on its own (called "residual beta-cell function"), blood sugar control, and levels of certain proteins in the blood. Not everyone finished the trial — 13 of the 18 in the vitamin D group and 16 of the 18 in the placebo group completed it. The reported data shows that the main thing being measured — the body's own insulin production, estimated using a substance called C-peptide (measured in ng/ml, a standard unit of concentration) — appeared to decline over the 12 months in both groups. At the start, the vitamin D group measured 1.78 ng/ml and the placebo group 2.27 ng/ml; by 12 months, these figures had fallen to 1.05 and 1.15 ng/ml respectively. For blood sugar control (measured as HbA1c, a percentage reflecting average blood sugar over time), both groups recorded similar figures across the year, starting around 7.6% and 7.5% and ending at 7.65% and 8.03%. The reported data also shows measurements for two blood proteins — GLP-1 and Vitamin D Binding Protein — tracked across the same five time points (0, 3, 6, 9, and 12 months), with figures fluctuating in both groups throughout the year. A combined score called IDAA1c, which factors in both blood sugar and insulin dose, was also recorded at each time point and showed broadly similar trends across both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04308291 · results posted 8 July 2024

According to the results reported on ClinicalTrials.gov, this trial involved 290 people with diabetes who used a device called the MiniMed™ 780G System — an automated insulin delivery system. The trial was designed to measure changes in blood sugar control, as well as people's satisfaction with their treatment, quality of life, fear of low blood sugar episodes, and time spent with blood sugar levels below a certain threshold. Participants went through an initial run-in phase before entering the main study, which ran for 12 months. The primary thing being measured was "time in range" — that is, the percentage of time a person's blood sugar sat within a target range of 70–180 mg/dL (considered a healthy window for people with diabetes). The reported data shows that, on average, participants' time in range increased by 11.81 percentage points between the start of the study and the six-month mark. For context, this means that if someone started with their blood sugar in the target range 50% of the time, they would have been recorded at roughly 61.81% of the time at six months — though individual results would have varied. For the secondary outcomes — including treatment satisfaction, quality of life, fear of low blood sugar events, and time spent with blood sugar below 70 mg/dL — the reported data shows no numerical results were submitted to ClinicalTrials.gov, so those figures are not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04599075 · results posted 8 July 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 70 pregnant women with diabetes, split evenly into two groups of 35. One group received insulin through a drip into a vein (intravenous insulin infusion) during labour, while the other group used an insulin pump under the skin (continuous subcutaneous insulin infusion, or CSII — a small wearable device that delivers insulin continuously). All 70 participants completed the trial. The study was primarily looking at newborn blood sugar levels shortly after birth, and also tracked a range of other measurements in both mothers and babies. The reported data shows that the average blood sugar reading in newborns within two hours of birth was 49.2 mg/dL (a unit used to measure sugar in the blood) in the intravenous group, and 50.1 mg/dL in the insulin pump group. For the mothers, low blood sugar episodes (readings below 60 mg/dL) were recorded in 5 participants in the intravenous group and 1 participant in the insulin pump group. No participants in either group developed a serious complication called diabetic ketoacidosis (a dangerous build-up of acids in the blood) during labour. The reported data also shows that average newborn birth weight was 3,067.8 grams in the intravenous group and 3,293.3 grams in the insulin pump group. A birth complication called shoulder dystocia (where a baby's shoulder becomes briefly stuck during delivery) was recorded in 4 participants in the intravenous group and 1 in the insulin pump group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01773707 · results posted 6 June 2024

According to the results reported on ClinicalTrials.gov, this trial involved 212 people — 101 received abatacept (given as an intravenous drip, meaning through a vein) and 111 received a placebo (an inactive treatment used for comparison). Almost all participants finished the study: 99 in the abatacept group and 108 in the placebo group. The trial was measuring how long it took for participants to develop abnormal blood sugar levels, as detected by a standard sugar-drink test called an Oral Glucose Tolerance Test (OGTT). It also looked at levels of a substance called C-peptide, which is a marker of how much insulin the body is producing. The reported data shows that, on average, the time until abnormal blood sugar levels were detected was approximately 89.2 months in the abatacept group and 71.6 months in the placebo group. For the secondary measurement, C-peptide levels — recorded during the sugar-drink test — were reported as 2.16 nmol/L in the abatacept group and 2.07 nmol/L in the placebo group. The reported data does not include further detail on what these differences between groups mean statistically, so no further interpretation of those figures can be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04992312 · results posted 23 May 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 7 participants, all of whom received at least one dose of a 3 milligram (mg) nasal glucagon (a hormone delivered as a nasal spray that can raise blood sugar levels) and all 7 completed the study. The trial was measuring two main things: first, whether participants experienced any unwanted medical events (called adverse events) that the study doctors considered related to the nasal spray; and second, how the spray affected participants' blood sugar levels and how the body processed the medication over time. The reported data shows that 5 out of the 7 participants experienced at least one treatment-related adverse event (an unwanted medical event that appeared or worsened after taking the study drug), while none of the 7 participants experienced a serious adverse event considered related to the study drug. Regarding blood sugar levels, the reported data shows that, on average, blood sugar rose by approximately 132 mg/dL from the pre-dose starting point, reaching an average peak level of around 242 mg/dL. That peak blood sugar level was reached at an average of about 55.6 minutes after the dose was given. The trial also measured how much of the medication entered the bloodstream and how it moved through the body over time, though these figures are highly technical and are reported in the data without further plain-English context being available from the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03428945 · results posted 9 April 2024

According to the results reported on ClinicalTrials.gov, this trial looked at whether hydroxychloroquine (a medicine more commonly known for treating conditions like lupus and malaria) might affect how long it takes for people with a certain level of blood sugar concern to develop abnormal blood sugar or diabetes. A total of 273 people took part — 183 were given hydroxychloroquine and 90 received a placebo (a dummy treatment with no active ingredient). Of those, 168 in the hydroxychloroquine group and 77 in the placebo group completed the study. The reported data shows that the primary outcome being tracked was the length of time, measured in months, from when participants were assigned their treatment until they developed confirmed abnormal blood sugar levels or clinical diabetes. According to the results reported on ClinicalTrials.gov, the average time recorded was 19.7 months for those in the hydroxychloroquine group and 18.8 months for those in the placebo group. No additional secondary outcome data appears to have been included in the structured results submitted, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03748433 · results posted 22 March 2024

According to the results reported on ClinicalTrials.gov, this trial involved 35 people in total — 17 in one group and 18 in another. Participants were divided into two groups based on how their blood sugar levels were monitored: one group used a Continuous Glucose Monitor (CGM), which is a small wearable device that tracks blood sugar levels automatically throughout the day and night, while the other group used traditional Self Monitoring of Blood Glucose (SMBG), which involves finger-prick tests. By the end of the study, 16 people in the CGM group and 14 in the SMBG group had completed the trial. The primary (main) outcome the trial was measuring was the percentage of time participants spent in hypoglycaemia — that is, the proportion of time their blood sugar levels dropped below a low threshold (3.0 mmol/L). The reported data shows that the CGM group spent an average of 1.8% of their time below this threshold, while the SMBG group spent an average of 3.3% of their time below it. It is worth noting that the results submitted to ClinicalTrials.gov only included this one primary outcome measure. No secondary outcome measure data was reported in the structured results available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04588259 · results posted 20 March 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04588259) compared two insulin products — "faster aspart" and "NovoRapid" (a standard insulin aspart) — in people using an insulin pump. A total of 331 people entered an initial run-in period, of whom 300 moved forward. From those, 150 were assigned to faster aspart and 150 to NovoRapid for a 16-week treatment period. The trial's main thing being measured was the change in a blood marker called HbA1c — a measure of average blood sugar levels over roughly the past two to three months — after 16 weeks. Several secondary measurements were also taken, including blood sugar levels after a standardised meal and fasting blood sugar levels. The reported data shows that for the main outcome, both groups had a small reduction in HbA1c from where they started: the faster aspart group's HbA1c fell by an average of 0.57 percentage points (or 6.18 mmol/mol), while the NovoRapid group's fell by an average of 0.54 percentage points (or 5.89 mmol/mol). For blood sugar after a standardised meal, the reported data shows the faster aspart group had reductions at the 30-minute and 1-hour marks (−1.01 and −0.94 mmol/L respectively), while the NovoRapid group had small increases at those same points (+0.18 and +0.46 mmol/L). At 2 and 3 hours after the meal, both groups showed increases from their starting point, with broadly similar figures. For fasting blood sugar, both groups showed a small increase from baseline (faster aspart +0.39 mmol/L; NovoRapid +0.20 mmol/L). For the average blood sugar measured across multiple points throughout the day (the 7-9-7 point profile), both groups showed a similar small reduction (faster aspart −0.73 mmol/L; NovoRapid −0.76 mmol/L). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04623086 · results posted 28 February 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04623086) enrolled 47 people in total across three groups. Nineteen participants were in a group that received insulin glargine followed by insulin degludec, 18 were in a group that received insulin degludec followed by a placebo (an inactive substitute), and 10 were in an "unassigned group" who did not complete the study. The trial was measuring changes in blood sugar control — specifically how much time participants' glucose levels spent within a target range (70–180 mg/dL) — in the 48 hours before and after their first dose of insulin degludec, using a continuous glucose monitor worn on the body. The reported data shows the following changes in the primary outcome — the percentage of time spent within the target glucose range: the glargine-then-degludec group showed a change of +2 percentage points, while the degludec-then-placebo group showed a change of −6.1 percentage points. For the secondary outcomes, the reported data shows: the variability of glucose levels (how much they fluctuated) changed by +3 in the glargine-then-degludec group and −1.1 in the degludec-then-placebo group; overnight time in the target range changed by +5.1 and −7 respectively; time spent with glucose mildly above range (181–250 mg/dL) changed by +5.4 and +6.5; time spent with glucose well above range (above 250 mg/dL) changed by +2.2 and +1.9; and time spent with glucose mildly below range (54–70 mg/dL) changed by +1.1 and −1.5. All figures represent percentage-point changes from the 48 hours before to the 48 hours after the first insulin degludec dose. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01724190 · results posted 28 February 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT01724190) compared Vitamin D against a placebo in people with recently diagnosed Type 1 diabetes. A total of 37 participants were enrolled — 19 in the Vitamin D group and 18 in the placebo group. By the end of the study, 15 people in the Vitamin D group and 14 in the placebo group had completed the trial, with 4 people in each group not finishing. The trial's main focus was measuring something called the IDAA1c score at 9 months after diagnosis. This is a combined score that takes into account both a person's blood sugar control (HbA1c) and how much insulin they need — it is used as a way to assess whether someone may be in a "partial remission" phase, sometimes informally called a "honeymoon period," where the body still produces some of its own insulin. A score below 9 was used to indicate this partial remission. The reported data shows that 5 out of 15 participants in the Vitamin D group and 2 out of 14 participants in the placebo group had a score below 9 at 9 months. No secondary outcome data was reported in the submitted results. It is worth noting that this was a small trial, and only one outcome measure was included in the reported results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04120974 · results posted 22 February 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04120974) enrolled 90 people who use insulin injections to manage their diabetes. All participants received education and guidance on what the study called "optimal insulin injection technique." The trial had one main group (no comparison group), and it tracked participants over six months. Of the 90 who started, 82 completed the trial and 8 did not finish. The reported data shows the following numbers across the main and additional measurements. For the primary measure — a blood test called HbA1c, which gives an average picture of blood sugar levels over roughly three months (reported as a percentage) — the group's average reading was 8.99% at the start and 8.20% at six months. For total daily insulin dose, the reported averages were 49.5 units at the start, 49 units at three months, and 51.2 units at six months. Low blood sugar episodes (hypoglycaemic events) were counted during two-week windows at each time point and expressed as how many events would be expected per person over a full year; the reported figures across different categories of low blood sugar ranged from 56.15 down to 7.43 across the time points measured. Average blood glucose readings (measured by finger-prick meters) were reported as 10.28 mmol/L at the start, and 11.03 mmol/L at both three and six months. A quality-of-life score (on a scale of 0 to 1, where higher means better) was 0.76 at the start and 0.78 at six months. Finally, the number of participants who reported using a fresh needle for every injection was 4 at the start, rising to 66 at three months and 73 at six months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04476472 · results posted 14 February 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04476472) enrolled 80 participants, all of whom completed the study — none dropped out. The trial was measuring how well a diabetes management device helped people keep their blood sugar levels within a healthy range, and how often serious blood sugar events occurred. The key things being tracked included blood sugar control (measured by a blood test called HbA1c, which gives an average blood sugar level over a few months), how much time participants spent with their blood sugar in a target range, and how often dangerous low blood sugar episodes (severe hypoglycaemia) or a serious complication called diabetic ketoacidosis (DKA) occurred. The reported data shows that rates of both severe low blood sugar events and DKA were very low — recorded at 0 to 0.0007 events per person per month, meaning these events were rare during the study period. For the HbA1c blood test, the reported figures across different measurement points ranged from 6.9% to 7.4%. For time spent with blood sugar in the broader target range of 70–180 mg/dL (a unit used to measure blood sugar concentration), the reported figures ranged from approximately 56.9% to 81.0% across different timepoints and participant groups. For a tighter target range of 70–140 mg/dL, the reported figures ranged from approximately 36.2% to 57.7%. It is worth noting that because multiple measurements appear in the data without clearly labelled timepoints or subgroup descriptions, the full context of each individual number cannot be confirmed from the information provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03740698 · results posted 5 February 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03740698) was designed to compare three different approaches to managing blood glucose levels in people with diabetes: a sensor-augmented pump system running in open-loop (where the person manually controls insulin), and two versions of a bi-hormonal artificial pancreas system using different methods to calculate mealtime insulin doses. The trial planned to run for six months and aimed to measure how much time participants spent with their glucose levels in a target range of 3.9–10 mmol/L. However, the study was terminated early — only two participants were enrolled and they remained in the trial for just two weeks. No participants were recorded as completing the study. The reported data shows that, of the two participants who took part, one was in the "BiAP, Fixed Bolus Calculator" group and one was in the "BiAP, ABC4D" group. No participants were enrolled in the "SAP, Open-loop" group, so no data was reported for that arm. For the primary outcome — the percentage of time glucose levels stayed within the target range — the reported figure for the Fixed Bolus Calculator participant was 70% of the time, and for the ABC4D participant it was 77% of the time. Because the trial ended so early and involved only two people, no further outcome data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02518945 · results posted 24 January 2024

According to the results reported on ClinicalTrials.gov, this trial involved 26 people with Type 1 diabetes. Participants were split into two groups: 9 people received a placebo (a dummy treatment with no active ingredient) and 17 people received active medications — a combination of dapagliflozin and liraglutide added on top of their usual insulin. All 26 participants completed the 12-week trial. The main thing the trial was measuring was the change in HbA1c — a blood test that reflects average blood sugar levels over roughly three months — after 12 weeks of treatment. The reported data shows that the placebo group's average HbA1c did not change (a reported change of 0 percentage points), while the active drugs group's average HbA1c changed by −0.66 percentage points from where it started. For the secondary measurements, the active drugs group spent about 10 percentage points more of their time with blood sugar in the target range (70–160 mg/dL), compared to a change of −1.4 percentage points in the placebo group. The amount of glucose passed out in urine over 24 hours increased by approximately 66.9 grams per day in the active drugs group, versus 2.1 grams per day in the placebo group. The active drugs group's daily insulin dose changed by −3.5 units per kilogram of body weight, compared to −0.1 in the placebo group. Body weight changed by −1.9 kg in the active drugs group and +0.7 kg in the placebo group. Finally, the top number of blood pressure (systolic) changed by −12 mmHg in the active drugs group and −2 mmHg in the placebo group. It is worth noting that this was a relatively small trial with only 26 participants across both groups, which is important context when considering what the numbers mean. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01722240 · results posted 23 January 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT01722240) enrolled 69 people in total — 35 in the liraglutide group and 34 in the placebo group. The trial ran for 52 weeks and was mainly measuring a blood marker called HbA1c, which reflects average blood sugar levels over roughly the previous three months. It also tracked average weekly blood sugar readings (using a continuous glucose monitor worn by participants) and body weight. The reported data shows the following for the main measure, HbA1c (given as a percentage — a higher number means higher average blood sugar): at the start of the trial, the liraglutide group averaged 7.92% and the placebo group averaged 7.48%. After 52 weeks, the liraglutide group averaged 7.45% and the placebo group averaged 7.58%. For average weekly blood sugar readings (in mg/dL, a unit used to measure sugar in the blood), the liraglutide group started at 173 mg/dL and finished at 156 mg/dL, while the placebo group started at 160 mg/dL and also finished at 156 mg/dL. For body weight, the liraglutide group started at an average of 83.6 kg and finished at 80.5 kg, while the placebo group started at 84.1 kg and finished at 83.8 kg. It is worth noting that not everyone completed the trial — 9 people in the liraglutide group and 14 in the placebo group did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03379792 · results posted 5 January 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03379792) enrolled 36 people across six groups, divided by whether they had Type 1 diabetes or not (the "control" group), and then further divided by body weight category — lean, overweight, or obese. All 20 people with Type 1 diabetes completed the study, while 9 of the 12 people in the control groups completed it (one person from each control weight category did not finish). The trial was measuring energy expenditure — essentially, how many calories the body burns over a period of time — using a specially designed room that tracks the gases a person breathes in and out. The reported data shows the average number of calories burned (measured in kilocalories) for each group. Among those with Type 1 diabetes, the lean group burned an average of around 1,978 kilocalories, the overweight group around 1,970 kilocalories, and the obese group around 2,415 kilocalories. Among the control participants without diabetes, the lean group burned an average of around 1,498 kilocalories, the overweight group around 1,902 kilocalories, and the obese group around 2,671 kilocalories. Only this one primary outcome measure was included in the submitted results data; no secondary outcome data was reported in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01280682 · results posted 11 December 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT01280682) involved 120 people split into two groups: 90 participants received rituximab, and 30 were in a parallel control group (meaning they did not receive rituximab, for comparison purposes). All 30 control participants completed the study, while 77 of the 90 in the rituximab group completed it — 13 did not finish. The trial was measuring changes in something called C-peptide, which is a substance in the blood that reflects how much insulin the body is still producing on its own. Participants were tested at the start of the study and again at 6 months, using a standardised meal test to see how C-peptide levels changed over time. The reported data shows that, when looking at the primary measure — the average C-peptide level across the 3-hour meal test — the rituximab group had a very small change of −0.01 units (on a log scale used for the analysis), while the control group had a change of −0.35 units. Similar patterns were reported for the secondary measures: fasting C-peptide (before the meal) changed by −0.03 in the rituximab group versus −0.34 in the control group, and the peak C-peptide (highest level during the meal test) changed by −0.01 versus −0.29, respectively. In all three C-peptide measures, the numbers suggest a smaller decline was recorded in the rituximab group compared to the control group, though this summary does not include any statistical analysis of whether the difference was meaningful. The reported data also shows that HbA1c — a measure of average blood sugar levels over roughly the past three months, reported as a percentage — was 6.84% in the rituximab group and 9.35% in the control group at the time of measurement. No information about side effects or safety outcomes was included in the structured results data submitted to ClinicalTrials.gov, so that data was not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04503174 · results posted 8 December 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 3,061 participants of all ages (from 6 years old through to adults) who were living with diabetes and using a device called Control-IQ — an automated insulin delivery system. Of those who started, 2,998 completed the study. The trial was measuring how often serious low blood sugar episodes (called severe hypoglycaemia) and a serious complication called diabetic ketoacidosis (DKA, where harmful acids build up in the blood) occurred over time. It also looked at how often blood sugar levels stayed within a healthy target range, as measured by a continuous glucose monitor (CGM — a small sensor worn on the body that tracks blood sugar throughout the day). The reported data shows that, across different groups of participants, severe hypoglycaemia occurred at a rate of roughly 8 to 10 events per 100 patient-years (meaning if you followed 100 people for one year, you would expect to see around 8–10 such events among them). DKA rates varied more noticeably across groups — ranging from about 1 to 3.6 events per 100 patient-years, with higher rates reported in those who had no prior experience using a CGM before the trial. For the blood sugar time-in-range measure (the target range being 70–180 mg/dL), the reported data shows adults spent about 70.1% of the time in that range over 12 months, while younger participants aged 14–17 and 6–13 were reported at around 60.9% and 61.2% respectively, giving an overall figure of 67.3% across all participants. The reported data also shows that adults spent approximately 28.6% of the time with blood sugar above 180 mg/dL, compared to around 37% for both younger age groups, with an overall figure of 31.4%. Time spent above 250 mg/dL (a higher threshold indicating more significantly elevated blood sugar) was reported at 6.3% for adults, 12.8% for 14–17 year-olds, 12.7% for 6–13 year-olds, and 8.0% overall. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00385697 · results posted 5 December 2023

According to the results reported on ClinicalTrials.gov, this trial involved people with type 1 diabetes and was testing a drug treatment sometimes called the "Herold Regimen." The trial ran in two main stages. In the first, open-label stage (where everyone knew what treatment was being given), 38 people took part and 35 finished. In the second, double-blind stage (where neither participants nor researchers knew who was getting which treatment), 516 people were enrolled across four groups — three groups receiving different versions of the active treatment and one group receiving a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how many participants, at 52 weeks, had both a low daily insulin dose (under 0.5 units per kilogram of body weight per day) and a blood sugar control reading called HbA1c (a measure of average blood sugar over roughly three months) below 6.5%. The reported data shows that in the double-blind stage, the number of participants who met both of those targets at 52 weeks was: 41 out of 207 in the full-dose active treatment group, 14 out of 102 in the one-third-dose group, 22 out of 106 in the "curtailed" (shortened course) treatment group, and 20 out of 98 in the placebo group. For the average change in HbA1c from the start of the double-blind stage, the reported figures were small reductions across all groups: minus 0.42 percentage points for the full-dose group, minus 0.34 for the one-third-dose group, minus 0.36 for the curtailed group, and minus 0.43 for the placebo group. In the earlier open-label stage, 11 out of 35 participants met the combined target, and the average HbA1c change was a small increase of 0.25 percentage points. The reported data also included a secondary measure looking at the body's own insulin-producing ability, assessed through something called C-peptide levels (a marker of how much insulin the pancreas is making on its own). Across all four double-blind groups, C-peptide levels showed small declines from the start of the study — the reported changes ranged from minus 0.18 to minus 0.27 in the units used — and a decline of minus 0.45 was reported for the open-label group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04176731 · results posted 13 November 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04176731) enrolled 36 participants, all of whom completed the study — none dropped out. The trial was testing a hybrid closed-loop system (a device that automatically adjusts insulin delivery based on continuous glucose readings) and comparing it to standard therapy. The main things being measured were: how often participants experienced dangerously low blood sugar (severe hypoglycaemia) or a serious complication called diabetic ketoacidosis (DKA), and how much time participants spent with their blood sugar in a target range of 70–180 mg/dL (a level considered neither too high nor too low). The reported data shows that zero out of 36 participants experienced severe hypoglycaemia, and zero experienced DKA during the study. For the "time in range" measurements — that is, the percentage of time blood sugar stayed between 70 and 180 mg/dL — the reported figures varied depending on the period being looked at. During the standard therapy period, the reported time-in-range figures were around 58–59%. During the hybrid closed-loop phase, the reported figures were higher, ranging from roughly 62% to 73% depending on whether it was a "challenge day" (where specific blood sugar targets were tested) or a regular day, and which subgroup of participants was being looked at. The reported data also shows average blood sugar readings across the different periods, ranging from approximately 163 to 173 mg/dL. These figures are as submitted by the trial sponsor and cover the specific groups and time periods measured in this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04320069 · results posted 13 November 2023

According to the results reported on ClinicalTrials.gov, 25 people took part in this trial, which tested the Omnipod Horizon™ Automated Glucose Control System — a wearable insulin delivery device. The trial ran in two phases: first without a continuous glucose monitor (CGM, a small sensor that tracks blood sugar levels throughout the day), and then with one. All 25 participants completed both phases. The trial was measuring how much time participants spent with their blood sugar levels in various ranges — including too low, too high, or very high. The reported data shows the following results across the two phases (Phase 1 without CGM, then Phase 2 with CGM). For blood sugar levels below 70 mg/dL (considered low), participants spent an average of 2.8% and 2.1% of the time there respectively. For levels above 180 mg/dL (considered high), the reported figures were 32.1% and 34.0% of the time. The reported average blood sugar readings were 158.7 mg/dL and 163.3 mg/dL across the two phases. For very low blood sugar (below 54 mg/dL), participants spent 0.5% and 0.3% of the time at those levels. For very high readings above 250 mg/dL, the figures were 8.2% and 9.7%, and above 300 mg/dL, 2.0% and 2.6% of the time respectively. The reported data shows results from a single group only — there was no separate comparison group — so these numbers reflect what was observed in participants using the device, without a direct comparison to another treatment or approach. No comparison figures between the two phases were reported in the structured results beyond the individual measurements listed above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04200313 · results posted 7 November 2023

According to the results reported on ClinicalTrials.gov, this trial tested a device called the "bionic pancreas" (the iLet system) in people with diabetes. The main part of the trial — the randomised controlled trial (RCT), where participants are randomly assigned to different groups — enrolled 440 people across three groups: 219 used the bionic pancreas with one type of insulin (Aspart or Lispro), 114 used it with a different insulin (Fiasp), and 107 continued their usual diabetes care. The trial also included smaller separate phases involving additional participants in an ancillary study, a transition phase, and an extension phase. The main thing being measured over 13 weeks was HbA1c — a blood test that reflects average blood sugar levels over roughly three months — along with several measures from a continuous glucose monitor (CGM), a small wearable sensor that tracks blood sugar throughout the day. The reported data shows that at 13 weeks, the average HbA1c reading was 56 mmol/mol in the Aspart/Lispro bionic pancreas group, 54 mmol/mol in the Fiasp bionic pancreas group, and 61 mmol/mol in the usual care group. For the CGM readings, the average blood sugar level over 13 weeks was reported as 164 mg/dL, 155 mg/dL, and 181 mg/dL for those same three groups respectively. The reported data shows the percentage of time blood sugar stayed within a commonly referenced target range of 70–180 mg/dL was 65% for the Aspart/Lispro group, 71% for the Fiasp group, and 54% for usual care. The proportion of time blood sugar was very low (below 54 mg/dL) was 0.33%, 0.26%, and 0.24% across the three groups. Time spent with blood sugar above 180 mg/dL was 33%, 27%, and 44%, and time above 250 mg/dL was 8.5%, 4.8%, and 14.9% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05286450 · results posted 10 October 2023

According to the results reported on ClinicalTrials.gov, this study enrolled 153 diabetic university students at Sohag University in Egypt. All 153 participants completed the study, with no drop-outs recorded. The study was not testing a treatment; instead, it was measuring how well the students managed their diabetes day-to-day. This was done using a standardised questionnaire called the Diabetes Self-Management Questionnaire (DSMQ), which asks people about four areas of diabetes self-care: blood sugar (glucose) management, diet, physical activity, and use of health care services. The reported data shows how the 153 participants answered questions across each of those four areas. For glucose management, the number of participants giving each recorded response ranged from 1 to 108 across the different answer categories. For dietary control, participant counts per response category ranged from 12 to 71. For physical activity, counts ranged from 14 to 90 across the response categories. For health care use, counts ranged from 12 to 72. The specific question wording and response-category labels for each of these figures were not included in the data as submitted to ClinicalTrials.gov, so it is not possible to describe exactly what each individual number represents beyond the raw participant counts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05067270 · results posted 4 October 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT05067270) enrolled 40 participants in total — 8 people in each of five groups. It was a crossover study, meaning every participant received the same treatment delivered to five different injection sites over five separate periods: the upper arm, thigh, abdomen (using a 6 mm needle), abdomen (using a 9 mm needle), and buttock. All 40 participants completed every period of the trial. The study was measuring pain at the injection site for each body location, using a standard pain scale. The reported data shows that pain was measured using a Visual Analog Scale (VAS) — a simple 0 to 100 millimetre line where 0 means "no pain" and 100 means "the worst imaginable pain." According to the results reported on ClinicalTrials.gov, the scores across all five injection sites were very low. The reported figures for the arm were 3.4, 3.7, and 4.8; for the thigh, 2.0, 2.6, and 3.4; for the abdomen with a 6 mm needle, 1.8 and 2.3; for the abdomen with a 9 mm needle, 1.9 and 2.0; and for the buttock, 2.4 and 3.3. It should be noted that the data as submitted appears to include multiple measurements per site, but a full breakdown of all time points was not clearly reported for every site, so some figures may be incomplete as provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00913497 · results posted 18 September 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 16 people, all of whom received both insulin glulisine and insulin aspart at different points during the study (meaning the same group tried both treatments). Thirteen participants completed the study, and three did not finish. The trial was measuring blood sugar levels after meals — specifically how much blood sugar rose above the pre-meal level at two hours and four hours after eating — when using each of the two types of insulin over 20 study days. The reported data shows that, for blood sugar measured two hours after a meal, the average rise above the pre-meal level was 136.4 mg/dL (milligrams per decilitre, a standard unit for measuring sugar in the blood) with insulin glulisine, and 133.4 mg/dL with insulin aspart. At four hours after a meal, the reported average rise was 113.5 mg/dL with insulin glulisine and 98.6 mg/dL with insulin aspart. The trial also reported a figure of 5.5 and 4.4 mg/dL respectively for a third measurement point, though the data as submitted does not clearly label what time point this represents. As a secondary outcome, the trial also counted episodes of hypoglycaemia (low blood sugar). The reported data shows two sets of figures for each insulin: 8 events and 19 events were recorded for insulin glulisine, and 9 events and 26 events for insulin aspart — though the data does not clearly explain the difference between these two counts (for example, whether they reflect different severity levels or time periods). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03841526 · results posted 25 August 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03841526) enrolled 48 people in total across several treatment groups. The trial was looking at whether a ready-to-use form of glucagon (a hormone that raises blood sugar) — given just before exercise — could reduce the number of low blood sugar episodes (hypoglycaemia) in people with diabetes who use insulin pumps and who do moderate to high intensity aerobic exercise. Participants went through a supervised clinic phase and then a 12-week at-home (outpatient) phase, where they exercised at least two to three times per week and self-administered their assigned treatment shortly before each session. The reported data shows that during the outpatient phase, the group using glucagon with an insulin pump reduction experienced on average about 0.12 low blood sugar events per exercise session, with a mean of roughly 1.9 such events per person overall. The group using a placebo (called "vehicle") with an insulin pump reduction reported a higher average rate of about 0.39 events per session, and a mean of around 8.4 events per person. The group using glucagon without an insulin pump reduction reported approximately 0.16 events per session and a mean of about 2.9 events per person. Across all participants combined, the reported average was 0.24 events per session and 4.3 events per person. For the secondary measures, the reported data shows that low glucose readings (at or below 70 mg/dL) were recorded for 14 participants each in the glucagon-with-pump-reduction and placebo groups, and 12 in the glucagon-without-pump-reduction group, during the outpatient phase. Changes in insulin use across the study weeks varied between groups and time points, and the full pattern of those figures was not straightforward to summarise from the data as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04732780 · results posted 25 August 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04732780) involved 253 participants, all of whom completed the study with no drop-outs. The trial was measuring the emotional and psychological experiences of people living with diabetes, using a series of questionnaires. These questionnaires asked participants about things like worry around blood sugar levels going too high or too low, feelings of anxiety, low mood, and the general stress of managing diabetes day-to-day. The reported data shows the following average scores across the group. On the Hyperglycaemia Avoidance Scale — which measures how much people try to avoid high blood sugar, scored 0 to 96 — the average score was 44.6. On the GAD-7 anxiety questionnaire (scored 0 to 21), the average was 4. On the PHQ-9 low mood questionnaire (scored 0 to 27), the average was 5. On the State Trait Anxiety Inventory trait scale (scored 20 to 80), the average was 42.4. On the Hypoglycaemia Fear Survey behaviour section — which looks at actions people take to avoid low blood sugar, scored 0 to 60 — the average was 17.2. Finally, on the Problem Areas in Diabetes 5 scale, which measures diabetes-related stress (scored 0 to 20), the average was 8. In every case, a higher score on a given scale means more of that feeling or behaviour was reported. The worry section of the Hypoglycaemia Fear Survey was noted as reported separately, but those figures were not included in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01945060 · results posted 21 August 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT01945060) enrolled 20 people in total, split into two groups of 10. It used a "crossover" design, meaning each group tried both conditions — one group started with a treatment called hrCTR and then switched to no hrCTR, while the other group did it in the opposite order. By the end of the study, 18 of the 20 participants had completed it, with one person from each group not finishing. The trial was measuring something called the Low Blood Glucose Index (LBGI), which is a score used to capture how often and how severely a person's blood glucose dropped to low levels during the study period. The reported data shows that the LBGI is scored on a scale from 0 to 100, where a higher number means more frequent or more severe low blood glucose episodes. According to the results reported on ClinicalTrials.gov, the group receiving hrCTR recorded an average LBGI score of 1.4, while the group not receiving hrCTR recorded an average score of 1.9. No secondary outcome data appears to have been reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03199638 · results posted 14 August 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03199638) involved 14 people in total, split into two groups of 7: one group did exercise only, and the other did exercise combined with a supplement called glutamine. The trial was looking at blood sugar control in people with diabetes, using several measures including a blood test called HbA1c (which reflects average blood sugar levels over roughly three months), continuous glucose monitoring (a device worn to track blood sugar throughout the day), and insulin doses used at home. Of the 14 who started, 12 completed the trial — all 7 in the exercise-only group finished, while 2 of the 7 in the exercise-plus-glutamine group did not complete it. The reported data shows the following numbers for the main measure, HbA1c (reported as a percentage — a lower number generally means blood sugar has been closer to normal). At the start, the exercise-only group had an average HbA1c of 7.9% and the exercise-plus-glutamine group had 8.3%. At the end of the study, these figures were 8.0% and 8.4% respectively. For the continuous glucose monitoring results, the reported data shows that the proportion of time blood sugar stayed within a target range (70–180 mg/dL) was 63.7% (exercise only) and 57.6% (exercise + glutamine) at the start, changing to 46.4% and 69.2% by the end. Blood sugar readings below the target range were recorded at 7.2% and 3.1% at the start, and 7.2% and 4.4% at the end. Readings above the target range were 29.1% and 39.4% at the start, and 46.4% and 26.6% at the end. Average swings in blood sugar levels (called MAGE) were 129 and 108 mg/dL at the start, and 139 and 123 mg/dL at the end. Insulin doses (in units per kilogram of body weight per day) were 1.0 and 0.98 at the start, and 0.8 and 1.0 at the end. It is worth noting that this was a small trial with only 14 participants, and the data as submitted does not include information about whether any of these differences between or within groups were considered statistically meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00357890 · results posted 7 July 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people with type 1 diabetes — six in each group. One group used an insulin pump (called continuous subcutaneous insulin infusion, or CSII), while the other used multiple daily injections (MDI). All 12 participants completed the trial. The study was measuring two main things: how sensitive the body was to insulin, and how well the insulin-producing cells (called beta cells) were still working. It also tracked long-term blood sugar control (HbA1c — a standard blood test that reflects average blood sugar over roughly three months) and body fat percentage. The reported data shows the following numbers for the two primary outcomes. For insulin sensitivity — measured using a specialised test where glucose is carefully infused to keep blood sugar steady; a higher number means the body responds better to insulin — the pump group recorded values of 8.6 and then 5.8 mg/kg/min at different time points, while the injection group recorded 6.2 and then 4.8 mg/kg/min. For beta cell function — measured by a protein called c-peptide, where a higher number suggests more insulin-producing activity remaining — the pump group recorded 2.1 and then 1.1 ng/mL, while the injection group recorded 1.7 and then 1.6 ng/mL. For the secondary outcomes, HbA1c started at around 10% in both groups; the reported data shows the pump group's figures moved to 6.1% and then 6.8%, while the injection group's moved to 7.0% and then 7.5%. Body fat percentage started at roughly 20% and 21.6% respectively, and the reported data shows it moved to 18.5% and then 17.4% in the pump group, and 20.3% and then 20.5% in the injection group. It is worth noting that this was a very small trial — just six people per group — so the numbers above reflect a limited snapshot only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02700048 · results posted 27 March 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02700048) set out to study the effect of intra-nasal (nose-spray) naloxone compared to a placebo (an inactive substance) on the body's hormonal response during episodes of low blood sugar (hypoglycaemia). Specifically, it aimed to measure whether naloxone changed the peak level of a stress hormone called epinephrine (also known as adrenaline) that the body releases during these episodes. The trial had two groups — a placebo group and a naloxone treatment group. The reported data shows that no participants were enrolled in the placebo group (zero started, zero completed). In the naloxone treatment group, three participants started the trial, but none completed it, and all three were recorded as "not completed." Because of this, the reported data shows no numerical results for any of the outcome measures — the primary measure (peak epinephrine levels during low blood sugar) and both secondary measures (which looked at how the body absorbed and processed naloxone, described as "Cmax" — the highest level of the drug in the bloodstream — and "AUC," a measure of total drug exposure over time) all have no figures reported. In other words, the results data for what was actually measured was not reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04503564 · results posted 7 March 2023

According to the results reported on ClinicalTrials.gov, this trial involved 20 participants who each used a device called the Achilles infusion set — a type of wearable device used to deliver insulin under the skin. The trial was looking at how well this device held up over extended wear periods at home. Each participant completed three separate wear periods of up to seven days each: one week using the device with saline (salt water, used as a comparison), and two weeks using the device with insulin. All 20 participants completed every stage of the trial. The reported data shows that the primary outcome being measured was "infusion set survival at end of day 7" — meaning how many of the devices were still working properly after a full seven days of wear. The reported figure was 36 infusion sets out of the total number used across the study still functioning at that point. The reported data does not include a breakdown of the total number of infusion sets that were used across all participants and periods, so it is not possible to calculate a percentage from the information provided. No secondary outcome data appears to have been reported in the submitted results on ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03952130 · results posted 8 February 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03952130) compared two insulin products — a standard insulin called Insulin Lispro (Humalog) and an experimental insulin called LY900014 — in people with diabetes. A total of 178 people were assigned to the Insulin Lispro group and 176 to the LY900014 group, with the vast majority completing the trial (176 and 170 people respectively). The main thing the trial was measuring was a blood marker called HbA1c — a test that reflects average blood sugar levels over roughly three months — and how much it changed over the course of the study. The reported data shows that, on average, HbA1c fell by 0.28 percentage points in the Insulin Lispro group and by 0.21 percentage points in the LY900014 group. The trial also measured blood sugar levels after a standardised test meal. One hour after the meal, the reported rise in blood sugar above the fasting level was 102.8 mg/dL for Insulin Lispro and 85.0 mg/dL for LY900014; at two hours after the meal, the figures were 142.2 mg/dL and 116.7 mg/dL respectively. A blood marker linked to short-term blood sugar swings (called 1,5-AG) increased by 0.39 mg/L in the Insulin Lispro group and by 0.10 mg/L in the LY900014 group. The reported data also shows rates of low blood sugar episodes (hypoglycaemia). Serious episodes requiring another person's help occurred at a rate of 6.88 events per 100 participant-years for Insulin Lispro and 5.87 for LY900014. Rates of lower-level symptomatic low blood sugar episodes after meals were reported across several time periods, ranging from around 0.11 to 10.2 events per person per year for Insulin Lispro and from around 0.09 to 12.4 events per person per year for LY900014, depending on the time period measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03751007 · results posted 1 February 2023

According to the results reported on ClinicalTrials.gov, this trial tested an investigational treatment called AG019 — either on its own or combined with another drug called teplizumab — in people with type 1 diabetes. A total of 45 participants took part, made up of both adults and adolescents, spread across 12 groups that received different doses (low or high), different schedules (single or repeated), or a combination with teplizumab or matched dummy (placebo) treatments. The trial's main focus was on counting and recording any unwanted health events (called "treatment-emergent adverse events") that occurred during the study period. The reported data shows that the number of these unwanted health events varied considerably across the groups. In the single-dose adult and adolescent groups, as few as 1 event was recorded per group. In the repeat-dose groups, the numbers were higher — for example, 6 events in the low-dose repeat adult group, 19 in the high-dose repeat adult group, 28 in the low-dose repeat adolescent group, and 19 in the high-dose repeat adolescent group. The largest number — 91 events — was recorded in the adults who received the active AG019 and teplizumab combination, compared with 25 events in the adults who received the double placebo in that same combination group. For the secondary measures, the reported data shows that no participants had detectable levels of the live bacteria (used in AG019) or its secreted proteins entering the bloodstream. Some participants did show detectable traces of the bacteria in faecal (stool) samples. A separate measure looked at a marker of insulin-producing cell activity (called C-peptide, measured after a test meal) at 12 months; reported average values ranged from 0.25 to 0.89 nmol/L across the different groups, though the data was not reported in a way that allows direct comparison between groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03345004 · results posted 9 January 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03345004) enrolled 57 people in the active treatment arm and 52 people in the placebo arm, with nearly all participants completing the study (56 and 51 respectively). The trial focused on people with type 1 diabetes and ran for 15 months. A key focus was on a subgroup of participants who carried a specific genetic marker called HLA DR3-DQ2 (29 in the active arm, 19 in the placebo arm). The main thing being measured was whether the body's own insulin-producing cells — tracked using something called C-peptide, a marker of how much natural insulin the pancreas is still making — changed over the course of the study. The reported data shows that for the primary measure (C-peptide, expressed as a ratio of the 15-month level compared to baseline, where 1.0 would mean no change), the active arm had a ratio of 0.551 and the placebo arm 0.506 — meaning both groups showed a decline in this marker over 15 months. In the HLA DR3-DQ2 subgroup, the reported ratios were 0.663 (active) and 0.425 (placebo). For the secondary measures, the reported data shows changes in HbA1c (a standard blood sugar control measure) of 0.53 mmol/mol in the active arm versus 1.04 mmol/mol in the placebo arm. Daily insulin use was reported as 0.183 IU/kg/24h in the active arm and 0.094 in the placebo arm. Around 62.7% of the active arm and 61.4% of the placebo arm met a combined blood sugar and insulin dose target (IDAA1c ≤ 9), while in the HLA DR3-DQ2 subgroup those figures were 78.6% and 40.0% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04094064 · results posted 21 December 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT04094064) enrolled 20 adults who use hemodialysis (a kidney treatment that filters the blood through a machine). All 20 participants completed the study — none dropped out. The trial was looking at how closely readings from a Continuous Glucose Monitor (CGM) — a small wearable sensor that tracks blood sugar levels automatically — matched blood sugar readings taken by two other methods: finger-prick tests done at home, and blood samples taken directly from the dialysis line during treatment sessions. The reported data shows two main measurements, both expressed as a "Mean Absolute Relative Difference" (MARD) — which is simply the average percentage gap between the CGM reading and the comparison reading at any given moment. For the finger-prick tests done at home (684 matched pairs of readings), the reported average difference was **13.8%**. For the blood samples taken from the dialysis line during hemodialysis sessions (624 matched pairs of readings), the reported average difference was **14.3%**. No other outcome figures were included in the submitted results data. The reported data describes only how closely the CGM readings matched the other two measurement methods in this group of 20 people. No conclusions about whether the CGM should or should not be used in this setting can be drawn from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04436796 · results posted 2 December 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people in total — 19 in one group and 16 in another. It used a "crossover" design, meaning participants tried both approaches at different times: an **artificial pancreas** system (a device that automatically adjusts insulin delivery based on continuous glucose readings) and a **sensor-augmented pump with predictive low glucose suspend** (a pump that uses glucose sensor data and can pause insulin if levels are predicted to drop too low). The trial's main measurements focused on how much time participants spent with their blood glucose in a target range, and how much time they spent at a very low glucose level. The reported data shows that, on average, participants using the artificial pancreas spent about **69% of the time** with glucose in the target range of 70–180 mg/dL (roughly 3.9–10 mmol/L), compared with **66%** when using the sensor-augmented pump. For very low glucose levels (below 54 mg/dL, or roughly 3 mmol/L — a level considered particularly concerning), the reported time was **0.41%** with the artificial pancreas and **0.71%** with the sensor-augmented pump. The reported data also shows secondary measurements. Average glucose readings were **158 mg/dL** (artificial pancreas) versus **156 mg/dL** (sensor-augmented pump). Time spent above 180 mg/dL was **29%** versus **30%**, and time above 250 mg/dL was **9%** versus **8%**. Time spent below 70 mg/dL (a low glucose level) was **2.1%** with the artificial pancreas and **3.5%** with the sensor-augmented pump. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04075513 · results posted 14 November 2022

According to the results reported on ClinicalTrials.gov, this trial compared two long-acting insulin medications — Toujeo and Tresiba — in people with diabetes. A total of 172 people were assigned to the Toujeo group and 171 to the Tresiba group, making 343 participants in all. Most participants completed the trial: 164 in the Toujeo group and 167 in the Tresiba group. The main thing the trial was measuring was how much time participants spent with their blood sugar levels in a target range (between 70 and 180 milligrams per decilitre), tracked using a continuous glucose monitor that recorded readings every five minutes over roughly weeks 10 to 12 of the study. The reported data shows that, on average, participants in the Toujeo group spent about 52.74% of the tracked time with their blood sugar in the target range, while those in the Tresiba group spent about 55.09% of the time in that range. For several secondary measures, the reported numbers were also similar between the two groups. A measure of how much blood sugar levels varied day-to-day (called the coefficient of variation, or CV% — essentially a way of expressing how spread out the readings were) was reported as 39.91% for Toujeo and 41.22% for Tresiba. A blood sugar marker called HbA1c — which gives a rough picture of average blood sugar levels over several months — changed by minus 0.75 percentage points in the Toujeo group and minus 0.92 percentage points in the Tresiba group from the start of the trial to week 12. Fasting blood sugar (measured in the morning before eating) changed by minus 16.05 mg/dL in the Toujeo group and minus 34.55 mg/dL in the Tresiba group over the same period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03445533 · results posted 8 November 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03445533) enrolled 481 people in total — 243 in the group receiving ipilimumab alone (Arm A) and 238 in the group receiving a combination of tilsotolimod (IMO-2125) plus ipilimumab (Arm B). The trial was measuring two main things: how many participants' tumours responded to treatment (called the "objective response rate," or ORR — meaning whether tumours shrank or disappeared based on scan measurements), and how many participants were still alive over the course of the study (called overall survival). The reported data shows that for the tumour response outcome, independent reviewers assessed scans for 243 participants in Arm A and 237 in Arm B. In Arm A, 1 person had a complete response (tumour disappeared entirely), 20 had a partial response (tumour shrank by 30% or more), 45 had stable disease (no significant change), and 110 had progressive disease (tumour grew). In Arm B, the reported numbers were 1 complete response, 20 partial responses, 61 stable disease, and 89 progressive disease. For the overall survival outcome, the reported data shows that out of 166 participants assessed in Arm A, 77 had died by the time data was recorded; out of 165 participants assessed in Arm B, 73 had died. It is worth noting that a large number of participants did not complete the study — 128 in Arm A and 193 in Arm B — though the reasons for this were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04398030 · results posted 9 August 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 7 people in total, split into two small groups who each tried both types of insulin cannula (a small tube inserted under the skin to deliver insulin) in a set order, with a two-week break in between. One group tried the coil-reinforced soft polymer cannula first, then switched to the soft Teflon cannula; the other group did the reverse. The trial was measuring how well insulin was absorbed through each type of cannula over a week of wear — specifically, whether the cannula's performance changed (declined) the longer it was worn. The reported data shows that for the primary measurement — how quickly insulin absorption declined over the wear period — the coil-reinforced soft polymer cannula recorded a slope of –0.102 and the soft Teflon cannula recorded a slope of –0.097. These figures represent the rate of decline in insulin absorption over time; a figure closer to zero would suggest less decline. For the secondary measurements, the reported data shows that the time it took for insulin to reach its peak level in the body was around 65–68 minutes on day 0 (insertion day) for both cannulas, dropping to around 25–31 minutes by day 7. The peak insulin level recorded was approximately 58–62 mU/L on day 0 and 87–97 mU/L on day 7 for both types. Other time-related insulin absorption figures followed a similar pattern across both cannulas, and the total amount of insulin absorbed over 300 minutes was also reported for both devices at day 0 and day 7. It is worth noting that this was a very small trial with only 7 participants, and not all participants completed every stage. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03557151 · results posted 6 July 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03557151) enrolled 208 participants in total — made up of 104 adolescents with Type 1 diabetes and their 104 caregivers. They were split into two groups: 74 participants received "usual care" (standard diabetes management), while 134 participants received "transdisciplinary care," which involved a broader team of health professionals and could be delivered either in person or via telehealth. The trial ran for 12 months and was measuring blood sugar control, self-care behaviours, diabetes-related distress, and quality of life. The reported data shows that the primary measure — HbA1c, a blood test that reflects average blood sugar levels over roughly three months (expressed as a percentage, where lower numbers generally indicate better blood sugar control) — started at around 8.59% for the usual care group and 9.02% for the transdisciplinary care group. By the end of 12 months, the reported figures were approximately 8.45% for usual care and 8.97% for transdisciplinary care. For the secondary measures of self-care behaviour (scored 0–84, higher meaning better), adolescents in both groups reported scores in the low-to-mid 50s across the study period, with caregivers reporting similar figures. Additional pre-specified measures tracked diabetes-related distress and quality of life across three time points; the reported data shows the transdisciplinary care group's distress scores (for both adolescents and caregivers) were somewhat lower at later time points, and adolescent-reported quality of life scores appeared higher in the transdisciplinary group at later time points, compared with the usual care group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04150107 · results posted 2 June 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total (14 in one group and 16 in another). It was a crossover study, meaning every participant went through three phases in sequence: a placebo (dummy/inactive) period first, then one active treatment, then the other active treatment — just in different orders depending on which group they were in. The trial was primarily measuring how much insulin participants needed (broken into "basal" insulin, which is the steady background dose, and "bolus" insulin, which is the dose taken around meals) compared to when they were on the placebo. By the final phase, 3 participants had not completed the study (2 from one group, 1 from the other). The reported data shows the following for the primary outcomes, looking at the last ten days of each treatment period. For basal (background) insulin, the baseline average was 27.28 mg/dL; with Treatment A it was 25.84 mg/dL (a reported difference of −1.43 from baseline), and with Treatment B it was 27.32 mg/dL (a reported difference of +0.04 from baseline). For bolus (mealtime) insulin, the baseline average was 20.63 mg/dL; Treatment A showed 20.77 mg/dL (difference of +0.14), and Treatment B showed 20.54 mg/dL (difference of −0.09). For total insulin combined, the baseline was 47.92 mg/dL; Treatment A showed a difference of −0.127 and Treatment B a difference of −0.04 from baseline. The reported data shows that secondary outcomes — which included daytime average blood glucose, how much blood glucose varied during the day (called "coefficient of variation," meaning how widely the readings fluctuated), and a score measuring the risk of low blood glucose episodes (called the Low Blood Glucose Index, or LBGI) — were also measured using a continuous glucose monitor. Daytime average glucose at baseline was 168.72 mg/dL, rising by 6.12 with Treatment A and 1.02 with Treatment B. The variability score changed by +1.64 with Treatment A and −0.291 with Treatment B from a baseline of 45.287%. The LBGI (low glucose risk score) was 1.65 at baseline, changing by −0.12 with Treatment A and 0.00 with Treatment B. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03377699 · results posted 27 April 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03377699) enrolled 111 people in the insulin degludec group (called IDeg) and 114 in the insulin detemir group (called IDet) — a total of 225 pregnant women with type 1 diabetes. The trial compared two types of long-acting insulin to see how well each kept blood sugar levels controlled during pregnancy. The main thing being measured was a blood test called HbA1c (a measure of average blood sugar over several weeks) taken at the last scheduled check-up before giving birth. By the end of the study, 89 participants in each group had completed the trial. The reported data shows that average HbA1c levels just before delivery were very similar between the two groups. In the IDeg group the average was around 6.30–6.32%, and in the IDet group it was around 6.26%, depending on the observation period used. For a secondary measure looking at how many participants reached an HbA1c of 6.5% or below before delivery, the reported data shows 58 people in the IDeg group and 53 in the IDet group reached that level (with 26 and 31 respectively not reaching it). For the stricter target of 6.0% or below, 36 people in the IDeg group and 31 in the IDet group reached that level. The reported data also shows average blood sugar 90 minutes after meals was 7.37 mmol/L for IDeg and 6.96 mmol/L for IDet, while fasting blood sugar was 6.17 mmol/L for IDeg and 6.79 mmol/L for IDet. During the pregnancy period, the number of recorded low blood sugar episodes (hypoglycaemia) was 5,431 in the IDeg group and 5,982 in the IDet group across all participants in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04552470 · results posted 11 March 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT04552470) involved 37 people in total, split across four groups: 9 received a placebo (dummy treatment), 10 received a 40 mg dose of PF-06882961, 9 received an 80 mg dose, and 9 received a 120 mg dose. All 37 participants completed the trial. The study was measuring how the body responded to different doses of PF-06882961, looking at things like unwanted medical events, blood and urine test results, blood pressure, heart rate, heart rhythm, and how much of the drug was present in the blood over time. The reported data shows that when it came to unwanted medical events (called adverse events), 3 out of 9 placebo participants, 7 out of 10 in the 40 mg group, 9 out of 9 in the 80 mg group, and 9 out of 9 in the 120 mg group recorded at least one such event. No serious adverse events — meaning no deaths, hospitalisations, or life-threatening events — were reported in any group. For blood and urine laboratory abnormalities, the reported numbers were 9 of 9 (placebo), 10 of 10 (40 mg), 8 of 9 (80 mg), and 9 of 9 (120 mg). No participants in any group recorded concerning heart rhythm readings outside the pre-set thresholds. The reported data also shows how much of the drug was detected in the blood: on the first day, blood levels ranged from around 33 to 46 nanograms per millilitre across the three dose groups, rising to between roughly 206 and 552 nanograms per millilitre by a later measurement point, with higher doses generally associated with higher recorded blood levels. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03651622 · results posted 4 March 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 68 people in total across three diet groups: a low-carbohydrate calorie-restricted diet, a moderate low-fat calorie-restricted diet, and a Mediterranean-style diet with no calorie restriction. The trial used an unusual design where participants could be reassigned to a different diet group up to three times over roughly ten-and-a-half months in total (three periods of about three-and-a-half months each). The trial was measuring two main things at the end of each diet period: changes in body weight (in kilograms) and changes in a blood marker called HbA1c — a measure of average blood sugar levels over the previous few months. The reported data shows the following changes in weight over each diet period. In the first period, all three groups saw a small reduction in weight: the low-carbohydrate group lost an average of 1.6 kg, the low-fat group lost 1.8 kg, and the Mediterranean group lost 1.5 kg. In the second period, the reported data shows small average weight increases across all three groups (0.27 kg, 0.99 kg, and 0.86 kg respectively). In the third period, the low-carbohydrate group recorded a small average increase of 0.68 kg, while the low-fat and Mediterranean groups recorded small average decreases of 0.85 kg and 0.64 kg respectively. For HbA1c, the reported changes were also small across all three periods and groups, ranging from a reduction of 0.48 percentage points to an increase of 0.72 percentage points depending on the diet group and period. It is worth noting that a number of participants did not complete each diet period, and many were reassigned to different diets between periods, which makes direct comparisons between groups complex. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03376789 · results posted 3 March 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03376789) enrolled 219 participants across two groups. One group of 108 people received a version of MYL-1501D called the "Process V" product, and the other group of 111 people received a version called the "Process VI" product. MYL-1501D is a form of insulin glargine, and the trial was comparing these two manufacturing versions of the same product. The main thing being measured was a blood sugar marker called HbA1c — a measure of average blood sugar levels over roughly two to three months — along with several other blood sugar-related measures. By the end of the study, 103 people in the first group and 102 in the second group had completed the trial. The reported data shows that for the primary measure — the change in HbA1c from the start of the trial — the Process V group had an average change of +0.18 percentage points, while the Process VI group had an average change of +0.15 percentage points. For the secondary measures, the reported data shows that fasting blood sugar (a blood glucose reading taken after not eating) changed by +0.64 mmol/L in the Process V group and +0.01 mmol/L in the Process VI group. The average daily insulin dose per kilogram of body weight changed by −0.004 units/kg in the Process V group and +0.007 units/kg in the Process VI group. Finally, the average of eight self-monitored blood glucose readings taken throughout the day changed by +0.10 mmol/L in the Process V group and +0.11 mmol/L in the Process VI group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03143816 · results posted 22 February 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 26 in the Technosphere Insulin (also known as Afrezza, an inhaled insulin) group and 34 in the Aspart (an injected insulin, sold as Novolog) group. Of those, 22 people in the Technosphere Insulin group and all 34 in the Aspart group completed the study. The trial was measuring several things related to blood sugar control, tracked using a continuous glucose monitor (CGM) — a small wearable device that records blood sugar levels throughout the day and night. The reported data shows that for the main outcome — the percentage of time participants spent with blood sugar in the target range of 70–180 mg/dl — the Technosphere Insulin group recorded 58.4% of the time in range, compared with 53.5% for the Aspart group. For the secondary outcomes, blood sugar rise after meals (measured over one to four hours) was reported as 45 mg/dl for the Technosphere Insulin group and 60 mg/dl for the Aspart group. A measure of how much blood sugar levels fluctuated (called glucose variability, reported in mg/dl) was 57.8 for the Technosphere Insulin group and 66.3 for the Aspart group. A calculation called "area under the curve" — which captures the total rise in blood sugar over four hours after meals — was reported as 15,020 units for the Technosphere Insulin group and 20,020 units for the Aspart group. The reported change in HbA1c (a measure of average blood sugar over roughly three months, expressed as a percentage) was 0.25% for the Technosphere Insulin group and 0.02% for the Aspart group. Finally, the percentage of time blood sugar was above 180 mg/dl was reported as 38.1% for the Technosphere Insulin group and 41.2% for the Aspart group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03740919 · results posted 24 January 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 751 people in a lead-in period, after which 716 moved forward and were randomly assigned to one of three treatment groups for 26 weeks: 298 received Insulin Lispro (Humalog, taken just before meals), 280 received LY900014 (also taken just before meals), and 138 received LY900014 taken after meals. The trial was primarily measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly three months — over 26 weeks. It also tracked low blood sugar episodes (hypoglycaemia) at various thresholds. The reported data shows that for the primary outcome, average HbA1c changed by +0.09 percentage points in the Insulin Lispro group and +0.06 percentage points in the LY900014 (pre-meal) group from their starting levels over 26 weeks. For the post-meal LY900014 group, the reported change was +0.07 percentage points. Regarding low blood sugar episodes (measured at a blood glucose level of 70 mg/dL or below), the reported data shows that around 94% of the Insulin Lispro group, approximately 93% of the LY900014 pre-meal group, and about 88% of the LY900014 post-meal group experienced at least one such episode during the treatment period. The rate of these episodes per person per year was reported as 78.0, 75.1, and 76.1 for the three groups respectively. Rates for more severe low blood sugar (below 54 mg/dL) were also reported, at 16.6, 16.1, and 17.7 episodes per person per year across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01816165 · results posted 21 January 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people in total — 10 with type 1 diabetes and 8 without diabetes. It was a "crossover" study, meaning each person took both the active drug (acipimox, a medicine that lowers fatty acid levels in the blood) and a dummy pill (placebo) in a random order, with a roughly two-week break in between. One person with type 1 diabetes did not complete the study. The trial was measuring several things: how sensitive the body was to insulin, the level of fatty acids in the blood over 24 hours, how well a major arm artery expanded in response to increased blood flow (a measure of blood vessel health), how active the energy-producing parts of muscle cells (mitochondria) were, and levels of two markers linked to inflammation in the body. The reported data shows the following numbers across the four groups. For insulin sensitivity (where a higher number means more sensitivity to insulin), people with type 1 diabetes recorded 4.65 on acipimox and 3.67 on placebo; people without diabetes recorded 8.80 on acipimox and 9.05 on placebo. For 24-hour average fatty acid levels in the blood, people with type 1 diabetes recorded 343 on acipimox and 297 on placebo, while people without diabetes recorded 298 on acipimox and 335 on placebo. For the artery expansion measure, people with type 1 diabetes recorded 8.21% on acipimox and 8.82% on placebo; people without diabetes recorded 5.88% on acipimox and 7.32% on placebo. For mitochondrial activity, multiple sets of measurements were reported across different fuel sources, ranging from roughly 25 to 80 units across all groups, with no large differences apparent between acipimox and placebo in either group. For the inflammation markers, IL-6 levels were 2.8 (type 1 diabetes, acipimox), 4.2 (type 1 diabetes, placebo), 2.6 (no diabetes, acipimox), and 3.5 (no diabetes, placebo); TNF-alpha levels were 1.76, 1.71, 1.56, and 0.91 respectively. It is worth noting that this was a very small study, and the reported data does not include the type of statistical detail (such as measures of uncertainty or significance) that would normally be needed to draw broader conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03993379 · results posted 1 December 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03993379) was testing a drug called CX-072 given in combination with other anti-cancer treatments. The trial was divided into four groups (called cohorts), covering different treatment combinations and patient situations. The main thing the trial set out to measure was the "overall response rate" — that is, how many participants' tumours shrank or disappeared to a meaningful degree, judged by a standard imaging measurement tool called RECIST v1.1. Only 3 participants were recorded as having started the trial, all of them in one group (Cohort A2: CX-072 in combination with ipilimumab). No participants were recorded as completing the study, and none were enrolled in the other three cohorts. The reported data shows that the primary outcome — the number of participants whose tumours responded to treatment by RECIST criteria — was zero across all groups. A secondary outcome used a slightly different measurement tool (irRECIST) to look for signs of anti-tumour activity; again, the reported number of participants showing a response was zero in every group. For the other secondary outcome, which tracked how many participants experienced side effects thought to be related to the treatment, the reported data shows that 1 participant in Cohort A2 was recorded in one category of treatment-related side effects, and 2 participants were recorded in two further categories — though given only 3 people were enrolled in total, the data was not reported in a way that allows for broader conclusions to be drawn. It is worth noting that because so few people were enrolled and none completed the study, the reported results reflect a very early and limited dataset. The data was not reported for most of the planned cohorts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02722499 · results posted 5 November 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total, split evenly into three groups of 20. Each group received financial incentives (money rewards) at different frequencies — high, moderate, or low — as part of a study looking at blood sugar management. The main thing the trial was measuring was a marker of average blood sugar levels over time, known as HbA1c, from the start of the trial to the three-month point. Nearly all participants completed the trial: 18 out of 20 in the high-frequency group, all 20 in the moderate-frequency group, and 19 out of 20 in the low-frequency group. The reported data shows that, on average, HbA1c levels changed from the starting point to three months by minus 1.73 units in the high-frequency incentive group, minus 1.73 units in the moderate-frequency incentive group, and minus 1.25 units in the low-frequency incentive group. A negative number here means the average blood sugar marker went down over that period. The trial also tracked healthcare costs as a secondary measure. The reported average costs over the same period were approximately US$3,315 for the high-frequency group, US$4,650 for the moderate-frequency group, and US$3,766 for the low-frequency group. No further breakdown of what contributed to these costs was included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03987191 · results posted 13 September 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people in total — 17 in a group following a standard care approach to switching insulin delivery methods, and 15 in a group following an investigational (experimental) approach. Two participants in the investigational group did not complete the study, leaving 13 who finished. The trial used a continuous glucose monitor (CGM) — a small device that tracks blood sugar levels throughout the day — to compare how blood sugar levels differed between the two groups over a seven-day period after they were assigned to their group. The reported data shows that for the main measurement — the percentage of time participants spent with blood sugar levels above 180 mg/dL (a level considered high) — the standard care group recorded 46.3% of the time above that threshold, while the investigational group recorded 38.5%. For time spent within a target blood sugar range (between 70 and 180 mg/dL), the standard care group recorded 47.8% and the investigational group recorded 56.5%. Time spent with blood sugar below 70 mg/dL (a low level) was reported as 3.9% for the standard care group and 2.1% for the investigational group. The reported data also shows that no participants in either group experienced a severe low or high blood sugar event requiring hospitalisation. The average number of extra insulin doses given per day to correct high blood sugar in the first 72 hours was reported as 6.5 for the standard care group and 4.0 for the investigational group. Finally, both groups scored 3.9 out of 5 on a satisfaction survey about their insulin delivery system. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03302234 · results posted 10 September 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03302234) enrolled 568 people in total — 284 in each group. Participants were randomly assigned to receive either pembrolizumab combined with ipilimumab, or pembrolizumab combined with a placebo (an inactive substitute). The trial was primarily measuring two things: how long participants lived overall (called "overall survival"), and how long they lived before their cancer showed signs of growing or spreading (called "progression-free survival"). A number of secondary outcomes were also tracked, including how many participants' tumours shrank, how long those responses lasted, how long it took for certain symptoms to worsen, and how many people experienced any unwanted medical events during the study. The reported data shows that for overall survival, the median time (meaning the point at which half the participants had passed away and half had not) was 21.4 months in the pembrolizumab-plus-ipilimumab group and 21.9 months in the pembrolizumab-plus-placebo group. For progression-free survival, the reported median was 8.2 months versus 8.4 months respectively. The proportion of participants whose tumours shrank to a meaningful degree was reported as 45.4% in both groups. Among those whose tumours did shrink, that response lasted a median of 16.1 months in the combination group and 17.3 months in the placebo group. For the symptom deterioration outcome (cough, chest pain, and shortness of breath), a median time to worsening was not reported for the ipilimumab group, while the placebo group recorded approximately 20 months. Regarding unwanted medical events, 272 out of 284 participants in the ipilimumab group and 263 out of 284 in the placebo group were reported to have experienced at least one such event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02293837 · results posted 17 August 2021

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called tocilizumab (TCZ) in people recently diagnosed with type 1 diabetes. It involved 136 participants in total — 54 children and young people received tocilizumab, 27 received a placebo (an inactive dummy treatment), 35 adults received tocilizumab, and 20 adults received the placebo. The trial was measuring whether tocilizumab could help preserve the pancreas's ability to produce its own insulin, using a substance called C-peptide as a marker — higher C-peptide levels indicate the pancreas is still making more insulin. Participants were tracked over the course of a year. The reported data shows that, for the primary outcome in children and young people, both groups saw a decline in C-peptide levels over the year. The tocilizumab group's average C-peptide measure fell by 0.337 pmol/mL, while the placebo group's fell by 0.391 pmol/mL. For secondary outcomes across both age groups, similar patterns of decline were reported in both the tocilizumab and placebo groups, with no large numerical differences between them. The reported data also shows that insulin use — the amount of insulin participants needed to inject — increased over the year in all groups, with figures reported as broadly comparable between tocilizumab and placebo groups in both children and adults. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01269034 · results posted 4 August 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 13 people in total, split across four groups: one person in Part A, two in Part B, one in Part C, and nine healthy volunteers used as a comparison group. The trial was set up to look at blood sugar levels after meals in people receiving different treatments — specifically comparing a medicine called exenatide with insulin alone — and to examine related measures such as the hormone glucagon (which raises blood sugar) and how quickly the stomach empties after eating. The reported data shows that, unfortunately, the actual results for all three outcome measures — the main (primary) measure and both additional (secondary) measures — are no longer available. According to the entry on ClinicalTrials.gov, the lead researcher has since left their institution, and all attempts to recover the data have been unsuccessful. This means no numbers for blood sugar changes, glucagon levels, or stomach emptying can be reported here, as the data was not submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00179777 · results posted 30 July 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 5,156 babies — 2,613 who were given a hydrolysed infant formula (where the milk proteins are broken down into smaller pieces) and 2,543 who were given a standard, non-hydrolysed infant formula. The trial was looking at whether the type of formula a baby received in early life had any connection to the later development of Type 1 diabetes or certain proteins in the blood called "autoantibodies," which are sometimes detected before Type 1 diabetes develops. Around 2,159 participants completed the study, while a large number did not complete it — the data does not explain the reasons for non-completion. The reported data shows that, for the primary outcome — the number of children who developed Type 1 diabetes — 91 participants in the hydrolysed formula group and 82 participants in the non-hydrolysed formula group were recorded as developing the condition. For the secondary outcome measuring diabetes-related autoantibodies, the reported data shows four separate sets of figures across both groups, though the data as submitted does not clearly label what each individual set of numbers refers to. The reported counts across the non-hydrolysed and hydrolysed groups were: 373 vs 394, 162 vs 183, 186 vs 207, and 102 vs 115 participants respectively. The reported data shows slightly higher numbers in the hydrolysed formula group across most of these measures, though no further analysis of what those differences mean is included in the structured data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03040414 · results posted 20 April 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 113 people in total (57 in one group and 56 in the other), with 111 completing the study. The trial used a "crossover" design, meaning participants tried both approaches at different times: one was a standard automated insulin delivery system (called the PID algorithm) and the other added an extra layer of decision-making to that system (called the PID + Fuzzy Logic algorithm). The main things being measured were how often participants' blood sugar levels were above a high threshold (above 10.0 mmol/L) during the day, and how often levels dropped below a very low threshold (below 3.0 mmol/L) over a full 24-hour period. The reported data shows that, for daytime high blood sugar readings, participants spent about 37% of the time above 10.0 mmol/L with the standard algorithm, compared with about 34% with the combined algorithm. For very low blood sugar (below 3.0 mmol/L) over 24 hours, both groups spent less than 1% of the time at that level — roughly 0.50% with the standard algorithm and 0.46% with the combined algorithm. The reported data also shows several secondary measurements: average blood sugar levels were recorded as 166 mg/dL (about 9.2 mmol/L) with the standard algorithm and 159 mg/dL (about 8.8 mmol/L) with the combined algorithm. The proportion of time blood sugar sat in a commonly used target range (3.9–10.0 mmol/L) was reported as 63% for the standard algorithm and 67% for the combined algorithm. A blood test called HbA1c — which gives a rough picture of average blood sugar over several months — was reported as 7.6% for the standard algorithm group and 7.4% for the combined algorithm group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00679042 · results posted 6 April 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 21 participants, all in a single treatment group. The trial was measuring two main things: first, whether participants experienced unwanted medical events (called adverse events) related to the procedure, the transplanted cell preparation, or the medicines used to prevent rejection; and second, whether participants reached a combined goal of having their blood sugar (HbA1c — a measure of average blood sugar over several months) at or below 6.5% and having no serious low blood sugar episodes in the year following their transplant. The study also tracked whether participants could stop using insulin injections and how often and how severely they experienced low blood sugar events over time. The reported data shows that, for the safety-related primary outcome, adverse events were recorded across all 21 participants at various points — with figures of 21, 11, 16, and 0 participants reported across different event categories (the data does not label each category individually, so a more detailed breakdown cannot be provided here). For the combined blood sugar goal, the reported data shows 8 out of 21 participants reached it by one year after their first transplant, and 11 out of 21 reached it by one year after their last transplant. Regarding insulin independence at the one-year mark, the reported figures vary across the several specific criteria measured, ranging from 3 to 12 participants depending on the particular measurement used. For low blood sugar episodes, a scoring system was used where a higher number means more severe problems — the reported average score was 266 at the start, dropping to around 40.6 and then 18.7 at later follow-up points. The reported data also shows reductions in that score of around 66% and 90% compared to the starting point, depending on the time of measurement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03338023 · results posted 29 March 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03338023) enrolled 272 people with diabetes — 137 in a group taking an insulin called LY2963016 (a biosimilar insulin glargine) combined with insulin lispro, and 135 in a group taking the brand-name insulin Lantus® also combined with insulin lispro. The trial's main focus was measuring changes in a blood test called HbA1c, which reflects average blood sugar levels over roughly two to three months. Most participants completed the study: 128 in the LY2963016 group and 125 in the Lantus® group. The reported data shows that, on average, HbA1c levels changed from the start of the study by minus 0.20 percentage points in the LY2963016 group and minus 0.08 percentage points in the Lantus® group. For blood sugar readings taken at various points throughout the day (up to seven checks), the reported data shows reductions in several readings for the LY2963016 group, while some readings in the Lantus® group showed small increases from their starting levels — the exact figures varied depending on the time of day measured. Regarding the proportion of participants reaching commonly referenced HbA1c targets, the reported data shows that about 30.7% of the LY2963016 group and 32.8% of the Lantus® group had an HbA1c below 7%, while about 15.7% and 22.4% respectively reached 6.5% or below. A measure of how much an individual's blood sugar varied across the day changed by minus 2.9 mg/dL in the LY2963016 group and minus 2.6 mg/dL in the Lantus® group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03911843 · results posted 23 March 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03911843) involved two groups of people with Type 1 diabetes: 26 newly diagnosed patients from 2017 (the "Cases" group, of whom 22 completed the study) and 38 people diagnosed previously (the "Controls" group, of whom 37 completed the study). The trial was measuring how much insulin participants needed each day, their blood sugar control over time (using a measure called HbA1c — a percentage that reflects average blood sugar levels over roughly three months), and how many participants met a threshold called "partial remission," meaning their bodies may still have been producing some of their own insulin. The reported data shows that at 12 months, the Cases group had an average daily insulin need of 0.49 units per kilogram of body weight per day, compared to 0.63 in the Controls group. For pre-meal insulin specifically, the reported figures were 0.22 (Cases) versus 0.34 (Controls). Regarding HbA1c, the Cases group recorded an average of 7.4% and the Controls group 7.8% — in both instances, lower numbers indicate better average blood sugar levels over the period. For the combined score used to assess partial remission (called IDAA1c, where a score below 9 is considered to meet the threshold), 12 out of 22 participants in the Cases group and 7 out of 37 in the Controls group were reported as falling below that threshold. It is important to note that these numbers are simply what was recorded and submitted by the trial's sponsors — they describe differences between the two groups as measured in this specific study. No conclusions about whether any treatment caused these differences should be drawn from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03617770 · results posted 5 March 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03617770) enrolled 14 people in total — 9 in a group called "Sleep-Opt-In" and 5 in a "Healthy Living" group. One person in the Sleep-Opt-In group did not finish the study, while all five in the Healthy Living group completed it. The trial was measuring two main things related to sleep — how long people slept each night (tracked using a wrist-worn movement monitor) and how regular their sleep patterns were — as well as several diabetes-related measures including blood sugar control, blood sugar variability, and emotional stress related to managing diabetes. The reported data shows that for sleep duration, the Sleep-Opt-In group recorded an average of 385 minutes per night and the Healthy Living group recorded 388 minutes per night. For sleep regularity (how much the timing of sleep varied night to night), the Sleep-Opt-In group had a variability figure of 46 minutes compared to 56 minutes in the Healthy Living group. On the secondary measures, the reported HbA1c (a measure of average blood sugar levels over roughly three months, expressed as a percentage) was 6.48% for Sleep-Opt-In and 6.7% for Healthy Living. Glucose variability (how much blood sugar levels fluctuated day to day) was reported as 34.4% for Sleep-Opt-In and 31.6% for Healthy Living. For diabetes distress — scored on a scale where under 2.0 suggests little distress and 3.0 or above suggests high distress — the Sleep-Opt-In group recorded 1.2 and the Healthy Living group recorded 3.1. It is worth noting that this was a very small trial with just 14 participants across both groups, which is important context when considering what these numbers mean. The reported figures are simply the values observed in each group at the time of measurement; no further detail about how the groups compared statistically was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03216226 · results posted 16 February 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 57 people in the dasiglucagon (ZP4207) group and 55 people in the GlucaGen group, with 52 and 50 people respectively completing the study. The trial was measuring whether either medicine caused the body to produce "antidrug antibodies" (ADA) — these are proteins the immune system can sometimes make in response to a medicine. Specifically, the trial looked at whether new antibodies appeared after treatment, whether any pre-existing antibodies increased significantly, and whether any such antibodies could interfere with the medicine's action. The reported data shows that, out of 56 people assessed in the dasiglucagon group and 54 people assessed in the GlucaGen group, zero participants (0 out of each group) tested positive for antidrug antibodies. This applied across all three measured categories: antibodies newly triggered by the treatment, antibodies that were already present and increased substantially after treatment, and the combination of both. Because no participants in either group tested positive for antidrug antibodies, the additional follow-up measures — such as whether any antibodies could neutralise the medicine or react with the body's own glucagon — were not reported, as there were no positive cases to assess. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01467063 · results posted 29 January 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 13 people in total — 6 in one group and 7 in the other. It was a crossover study, meaning participants tried both glutamine (a type of amino acid) and a placebo (an inactive substitute) at different times. The trial was measuring two things: insulin sensitivity (how well the body responds to insulin, which helps regulate blood sugar) and levels of a gut hormone called GLP-1 (Glucagon-like Peptide 1), which is involved in blood sugar control. Twelve of the 13 participants completed the study; one person in the glutamine-first group did not finish. The reported data shows that insulin sensitivity — measured using a specialised medical test called a hyperinsulinemic-euglycemic clamp — produced a value of 0.10 (in units of mL/kg/min per uU/mL) during the glutamine period, compared with 0.07 during the placebo period. For the secondary measure, GLP-1 levels were reported as 2.3 pmol/L (a unit measuring the concentration of the hormone in the blood) during the glutamine period, compared with 1.8 pmol/L during the placebo period. No further statistical detail (such as whether these differences were considered meaningful by standard testing) was included in the data submitted to ClinicalTrials.gov. It is worth noting that this was a very small study — just 13 participants — and the reported data does not include information about variability or statistical significance, so the numbers should be interpreted with that context in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03760068 · results posted 27 January 2021

According to the results reported on ClinicalTrials.gov, this trial compared two insulin products: MYL-1601D (a biosimilar candidate) and NovoLog® FlexPen (a well-established rapid-acting insulin), both at 100 units per millilitre. A total of 478 people took part — 238 in the MYL-1601D group and 240 in the NovoLog® group. The trial's main focus was on measuring whether participants' immune systems produced antibodies in response to the insulin (called a "treatment emergent antibody response," or TEAR — essentially a sign that the body has recognised the medicine as foreign). Secondary measurements looked at changes in blood sugar control markers and insulin doses over 24 weeks. The reported data shows that 59 out of 238 participants (roughly 25%) in the MYL-1601D group had a positive antibody response, compared with 67 out of 240 (roughly 28%) in the NovoLog® group. For blood sugar control, the average change in HbA1c (a measure of blood sugar levels over roughly three months) from the start of the trial to Week 24 was +0.10 percentage points for the MYL-1601D group and +0.04 percentage points for the NovoLog® group. Fasting blood glucose (sugar measured after not eating) changed by an average of +0.400 mmol/L for MYL-1601D and +0.599 mmol/L for NovoLog®. Small changes in insulin doses were also reported across both groups, with the MYL-1601D group showing slightly larger average increases in mealtime, basal (background), and total daily insulin doses compared with the NovoLog® group, though all changes were very small in absolute terms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03830281 · results posted 22 January 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03830281) compared two forms of insulin — standard Insulin Lispro (brand name Humalog) and a newer formulation called Ultra-Rapid Lispro — in people with diabetes. The trial began with a two-week lead-in period where 471 participants used the standard insulin. After that, 432 people who completed the lead-in were randomly assigned to one of the two groups for a 16-week treatment period: 217 people in the standard Insulin Lispro group and 215 in the Ultra-Rapid Lispro group. The main thing being measured was a blood test called HbA1c — a marker that reflects average blood sugar levels over roughly three months. The reported data shows that, by week 16, both groups had a small reduction in their HbA1c levels from where they started. The standard Insulin Lispro group's HbA1c fell by an average of 0.09 percentage points, while the Ultra-Rapid Lispro group's fell by 0.06 percentage points. For blood sugar measured one hour after a standardised test meal, the reported data shows the standard insulin group saw an average reduction of 2.2 mg/dL, compared with a reduction of 26.3 mg/dL in the Ultra-Rapid Lispro group. At the two-hour mark after the same test meal, the reported reductions were 4.2 mg/dL for the standard insulin group and 32.0 mg/dL for the Ultra-Rapid Lispro group. The reported data also shows the percentage of time participants spent with their glucose sensor reading in the target range (70–180 mg/dL) was broadly similar between the two groups, at around 58–59%. For low blood sugar episodes (hypoglycaemia), the reported rate of severe events was 2.95 per 100 participant-years in the standard insulin group and 6.36 in the Ultra-Rapid Lispro group. Milder but symptomatic low blood sugar events with a glucose reading below 54 mg/dL were reported at a rate of 30.7 episodes per person per year in the standard insulin group and 24.6 in the Ultra-Rapid Lispro group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02443155 · results posted 11 January 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 307 people across four groups. Participants were randomly assigned to receive either a combination of two investigational treatments (NNC0114-0006 plus liraglutide), NNC0114-0006 alone, liraglutide alone, or a placebo (an inactive dummy treatment). The trial ran for 54 weeks and was primarily measuring how well the insulin-producing cells in the pancreas were still working over that time — assessed by tracking a substance called C-peptide, which is released alongside insulin and is used as a marker of how much insulin the body is still making on its own. Between 61 and 67 participants in each group completed the full study. The reported data shows the main result as a ratio comparing each group's C-peptide levels at week 54 to where they started — a ratio of 1.0 would mean no change, while a lower number means a decline. For the combination group (NNC0114-0006 plus liraglutide), the reported ratio was 0.934, meaning C-peptide levels were about 93% of what they were at the start. For NNC0114-0006 alone the ratio was 0.783 (about 78% of baseline), for liraglutide alone it was 0.709 (about 71%), and for the placebo group it was 0.660 (about 66%). The reported data for the secondary measures followed a broadly similar pattern across the groups — including shorter time-window C-peptide readings and peak C-peptide levels — all showing ratios below 1.0 (i.e., some decline from baseline) in every group. For blood glucose levels after a meal, the combination group showed a ratio below 1.0 (around 0.90–0.94), while the other three groups showed ratios at or above 1.0, meaning little change or a slight rise compared to baseline. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03478254 · results posted 11 January 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 300 adults with Type 1 Diabetes Mellitus (T1DM), and all 300 completed the study. The trial was measuring how well this group of patients followed regional guidelines recommending that adults with T1DM receive three specific vaccinations: influenza (flu), pneumococcal (a vaccine against a type of serious bacterial infection), and hepatitis B. The reported data shows that, out of the 300 participants, 165 were recorded as adhering to the vaccination guidelines in some way. Breaking this down further, the data reports figures of 54, 51, and 30 participants across what appear to be the individual vaccination categories — though the reporting structure does not clearly label which number corresponds to which specific vaccine, so these figures should be interpreted with caution. The reported data also shows that the average ages associated with these vaccination groups were approximately 43.5, 39.7, 28.3, and 44.5 years respectively, suggesting the participants spanned a broad adult age range. For a secondary measure looking at sick leave, the reported data shows that 17 participants had taken sick leave related to the conditions being studied. It is worth noting that some details of how the measurements were grouped and labelled were not fully clear in the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02017171 · results posted 20 November 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02017171) enrolled 267 people in the allopurinol group and 263 people in the placebo group — a total of 530 participants. The trial was measuring kidney function over time, specifically looking at how well the kidneys filter blood (called the glomerular filtration rate, or GFR — a higher number generally means the kidneys are filtering more). Participants were treated for three years and then followed for a further two-month "wash-out" period (a time after stopping treatment to see what happened next). The main question the trial was trying to answer was whether kidney filtering rates differed between the two groups at the end of that wash-out period. The reported data shows that at the end of the wash-out period — the primary thing being measured — both groups had almost identical kidney filtering scores: 61.2 ml/min/1.73 m² in the allopurinol group and 61.2 ml/min/1.73 m² in the placebo group. The secondary measurements told a similar story. At four months into treatment, kidney filtering was 70.3 in the allopurinol group and 70.0 in the placebo group. At the end of the three-year treatment period, the figures were 61.3 versus 61.0. Both groups also showed a gradual decline in kidney filtering over the course of the study: roughly −3.0 units per year in the allopurinol group and −2.5 units per year in the placebo group (as measured by one method), and −2.4 versus −2.1 per year (as measured by a second method). Regarding a more serious outcome — the kidney filtering rate dropping to half its starting level, or progressing to kidney failure — 13 participants in the allopurinol group and 11 in the placebo group experienced this event, according to the reported data. It is worth noting that 62 participants in the allopurinol group and 46 in the placebo group did not complete the study, though the reasons were not detailed in the data provided here. All figures above have been reported as adjusted for each participant's starting kidney function level. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02927639 · results posted 20 November 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 165 young people with diabetes — 83 in the intervention group and 82 in the control group. The trial was measuring whether a particular approach made a difference to how well participants managed their diabetes over six months. Two things were tracked: a self-care score (based on a questionnaire asking how often people followed their diabetes management routines) and a blood sugar measure called HbA1c (a test that reflects average blood sugar levels over time). It is worth noting that only 10 people in the intervention group and 13 in the control group were recorded as completing the study, with the large majority not completing it. The reported data shows that at six months, the average self-care questionnaire score was 3.57 out of 5 for the intervention group and 3.62 out of 5 for the control group. On this scale, a higher number reflects more frequent self-care behaviours. For the second measure — the HbA1c blood sugar test — no results data was reported to ClinicalTrials.gov, so those figures are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02888691 · results posted 9 November 2020

According to the results reported on ClinicalTrials.gov, this trial compared two different diets — a low carbohydrate diet and a high carbohydrate diet — in people with (presumably) diabetes, to see how each diet affected blood sugar levels over time. A total of 14 participants were enrolled across two groups of 7. The trial used a "crossover" design, meaning participants moved through two separate diet periods. Not everyone completed both periods — in the first period, 13 of 14 participants finished, and in the second period, 10 of 12 who started finished. The main thing the trial measured was the percentage of time participants spent with their blood sugar in a target range (between 4.0 and 10.0 mmol/L, which researchers call "euglycemia" — essentially a normal, stable range). The reported data shows that participants on the low carbohydrate diet spent about 68.6% of the time in that target range, compared to 65.3% for those on the high carbohydrate diet. For the secondary measurements, the reported average blood sugar was 8.8 mmol/L on the low carbohydrate diet and 8.9 mmol/L on the high carbohydrate diet. The reported data also shows figures for how much blood sugar levels varied: on the low carbohydrate diet, the spread of readings (standard deviation) was 2.9 mmol/L versus 3.3 mmol/L on the high carbohydrate diet, and a related variability measure (coefficient of variation, meaning how much readings fluctuated relative to the average) was 32.7% versus 37.5%. The time spent with blood sugar at a low level (at or below 3.9 mmol/L) was reported as 1.9% on the low carbohydrate diet and 3.6% on the high carbohydrate diet. One secondary measure — the "mean amplitude of glycemic excursions" (a measure of the size of blood sugar swings) — was listed but no numbers were reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04020822 · results posted 16 September 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT04020822) enrolled 19 participants, all of whom completed the study. All participants wore a device called the Guardian Sensor (3), which is a continuous glucose monitor — a small sensor worn on the body that measures blood sugar levels automatically. The trial was looking at how closely the sensor's glucose readings matched readings taken from a standard finger-prick blood glucose meter, specifically around the time participants took acetaminophen (a common pain relief medication, known in Australia as paracetamol). This was done to understand whether taking acetaminophen had any influence on how accurately the sensor reported glucose levels. The reported data shows accuracy was measured using something called "Mean Absolute Relative Difference" (MARD) — in simple terms, this is the average percentage gap between what the sensor read and what the finger-prick meter read. A lower percentage means the two readings were closer together. The results were pooled across several testing days (days 3, 5, and 6). Three separate MARD figures were reported: 9.46%, 12.02%, and 16.98%. The trial report does not clearly specify which of these three figures corresponds to which time period or testing day, so the data as submitted does not allow a direct before-and-after comparison to be described with certainty. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01030861 · results posted 5 August 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 76 people in total — 44 received teplizumab (the treatment being studied) and 32 received a placebo (an inactive comparison infusion). All 76 participants completed the trial. The trial was measuring how often people in each group went on to develop type 1 diabetes over time, as well as tracking any unwanted health events that occurred during the study. The reported data shows that, for the primary measure — the rate at which participants developed diabetes — the teplizumab group had a reported rate of 43 cases per 100 participant-years, compared with 72 cases per 100 participant-years in the placebo group. ("Participant-years" is simply a way of accounting for how long each person was followed during the study.) For the secondary measure, the reported data shows that 43 out of 44 participants in the teplizumab group and 23 out of 32 participants in the placebo group experienced at least one adverse event (an unwanted health occurrence noted during the trial). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02632747 · results posted 24 July 2020

According to the results reported on ClinicalTrials.gov, this trial involved 31 adults in total, split into two groups in a "crossover" design — meaning each person took both the active medicine (empagliflozin 25 mg) and a dummy pill (placebo) in sequence, with a washout break in between. All participants were also taking a blood pressure medicine called ramipril throughout. The trial was measuring how well the kidneys filter blood — known as the glomerular filtration rate, or GFR, which is simply a measure of how much blood the kidneys clean per minute — after four weeks on each treatment. The reported data shows that after four weeks, the average kidney filtration rate was 124.0 mL/min/1.73m² in participants while taking empagliflozin, and 132.5 mL/min/1.73m² while taking the placebo. For a secondary measure looking at how many participants had a filtration rate below a certain threshold (120 mL/min/1.73m²), the reported data shows 1 participant fell below that level while on empagliflozin, compared with 0 on placebo; a separate part of that same measure recorded 1 participant (empagliflozin) and 2 participants (placebo), though the breakdown of these two sub-counts was not fully detailed in the submitted data. Importantly, the trial's own notes state that the planned statistical analysis — the formal comparison of the two groups — was not carried out, because there were too few participants in the specific subgroup the trial was designed to study (people whose kidneys were filtering at a higher-than-normal rate, called "hyperfilterers"). This means the numbers above are descriptive figures only, and no formal conclusion was drawn from them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02556554 · results posted 21 July 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 67 people across five groups: a routine care group (8 people), a group using a continuous glucose monitor called the Dexcom G4 Platinum (14 people), a group using the same monitor with a sharing feature called Share™ (19 people), and two "follower" groups — people (such as family members or carers) who could remotely view the glucose readings of the monitor-only group (12 people) or the Share™ group (14 people). The trial was measuring things like how much time participants spent with their blood sugar in a healthy range, how worried they felt about low blood sugar episodes, changes in a long-term blood sugar measure called HbA1c (a percentage that reflects average blood sugar over several months), and certain outcomes for mothers and babies. The reported data shows that, for time spent with blood sugar in range, the Dexcom-alone group recorded around 52.8% at one point and 50.7% at another, while the Share™ group recorded around 59.8% and 56.6%. For time spent with blood sugar too low, the Dexcom-alone group recorded around 7.5% and 5.0%, and the Share™ group around 7.3% and 5.3%. For the fear-of-low-blood-sugar questionnaire (where higher scores mean more fear or behaviour changes), the reported total scores for the Dexcom-alone group were 73.8 and 65.8, and for the Share™ group were 61.9 and 63.4. The reported HbA1c figures were 6.85% for routine care, 6.84% for the Dexcom-alone group, and 6.19% for the Share™ group. For maternal and infant outcomes, the reported data shows numbers of participants in each group experiencing various events, though the labels for each specific event were not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03465878 · results posted 18 June 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 81 participants in total across two parts (Part A and Part B). Participants ranged from children aged 2–11, adolescents aged 12–17, and adults aged 18–64, all of whom had type 1 diabetes. The trial was a crossover study, meaning each participant received both treatments being compared — an insulin called LY900014 (also known as ultra-rapid lispro) and a comparator insulin called Humalog (insulin lispro) — at different times. The trial was measuring how the body absorbed and responded to each insulin by tracking drug levels in the blood and blood sugar changes over several hours after a dose. The reported data shows that for the primary measure — the total amount of insulin lispro that entered the bloodstream over roughly seven hours (a measure called "area under the curve," which is simply a way of adding up drug levels over time) — the numbers were broadly similar between LY900014 and Humalog across all age groups and both study parts. For example, in children in Part A, the reported figures were 755 units for LY900014 and 754 for Humalog; in adolescents in Part A, 962 versus 908; and in adults in Part A, 987 versus 975. Similar patterns were seen in Part B. For the secondary measure — tracking how blood sugar levels changed over five hours after dosing — the reported figures also showed broadly comparable numbers between the two insulins across most groups, with some variation between age groups. For instance, in children in Part A, the blood sugar change figure was 384 for LY900014 and 492 for Humalog; in adolescents in Part A, 577 versus 651; and in adults in Part A, 372 versus 351. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02679287 · results posted 9 June 2020

According to the results reported on ClinicalTrials.gov, this trial involved 93 people in total (47 in Group A and 46 in Group B) who were living with diabetes and using insulin pumps. The trial was testing whether a "closed-loop control" system — where a device automatically adjusts insulin delivery overnight using sensor readings — could reduce the amount of time a person's blood sugar spent dangerously low (below 70 mg/dL), compared with a standard sensor-augmented pump that requires more manual management. Participants moved through several periods of the study, with around 79 people completing all phases. The reported data shows that, looking at both groups combined, the percentage of time blood sugar was below 70 mg/dL was 4.0% in one measurement period and 2.2% in another (the data as submitted does not specify which period each figure belongs to). For the blood sugar control marker known as HbA1c — a measure of average blood sugar over roughly three months, where lower generally means closer to a normal range — the reported figures were 7.42% and 7.11% across the two measurement points. For the secondary outcomes, the reported data shows that time spent in the healthy target range (70–180 mg/dL) was 58.6% with standard pump therapy, 67.6% with evening and overnight closed-loop control, and 69.5% with around-the-clock closed-loop control. Time spent with blood sugar above 180 mg/dL was reported as 37.4%, 30.1%, and 28.7% for those same three approaches respectively. Average blood sugar readings were 9.3, 8.82, and 8.74 mmol/L, and a risk index for low blood sugar (where a lower number suggests lower risk) was reported as 1.04, 0.66, and 0.57 across the three approaches. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03056456 · results posted 1 May 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants in total, split into four groups of six. It was a crossover-style study, meaning participants went through multiple periods and received different study treatments at different times. The trial was measuring two things: how much of an insulin product called LY900014 (an experimental fast-acting insulin) got into the bloodstream compared with an already-approved insulin called insulin lispro (brand name Humalog), and how blood glucose levels changed after a test meal. These measurements were taken after two different ways of delivering the insulin dose — a "single-wave" bolus (all at once) and a "dual-wave" bolus (partly all at once, partly spread out over time). The reported data shows that when insulin was delivered as a single-wave bolus, the total amount of LY900014 measured in the blood over five hours was reported as 1,040 and 1,050 units (picomoles per litre, multiplied by hours), while the comparator insulin lispro recorded 1,040 and 1,040 units across the two reported measurements. For the dual-wave bolus, LY900014 recorded 985 and 1,010 units, while insulin lispro recorded 956 and 969 units. Regarding blood glucose changes after a test meal (measured as the change from a starting level over five hours), the reported data shows that for the single-wave bolus, LY900014 recorded values of 16.8 and 140, while insulin lispro recorded 38.9 and 175 (in milligrams per hour per decilitre). For the dual-wave bolus, LY900014 recorded -1.87 and 188, while insulin lispro recorded 106 and 286 in the same units. The data does not provide additional context explaining the two separate measurements within each group, so further detail on this point was not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03214367 · results posted 1 May 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03214367) involved a lead-in period and a treatment period. In the lead-in phase, 1,316 people started using a standard mealtime insulin called insulin lispro (Humalog), of whom 1,222 completed that phase. A smaller separate group of 76 people also went through a lead-in under a "maximum extended enrolment" track. Those who completed the lead-in were then assigned to one of three treatment groups for 26 weeks: 442 people received LY900014 (a faster-acting insulin lispro) taken just before meals, 451 received LY900014 taken after meals, and 329 continued on standard insulin lispro taken before meals. Smaller numbers in each group were part of an extended enrolment sub-track. The main thing the trial was measuring was change in a blood sugar marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly three months. The reported data shows that at 26 weeks, the before-meal LY900014 group had an average change of −0.13 percentage points, the after-meal LY900014 group had a change of +0.08 percentage points, and the standard insulin lispro group had a change of −0.05 percentage points from where they each started. The trial also measured blood sugar spikes after a test meal. The reported data shows that one hour after the meal, the before-meal LY900014 group had an average reduction of 28.6 mg/dL in their post-meal blood sugar rise, compared with an increase of 12.5 mg/dL in the after-meal LY900014 group and a reduction of 0.7 mg/dL in the standard insulin lispro group. At two hours after the meal, reductions were 34.7, 10.2, and 3.5 mg/dL respectively. The reported data also includes figures for low blood sugar (hypoglycaemia) events. Severe hypoglycaemia — meaning episodes serious enough to need someone else's help — was reported at a rate of 16.50 events per 100 person-years for before-meal LY900014, 13.70 for after-meal LY900014, and 18.34 for standard insulin lispro. Less severe but still symptomatic low blood sugar events were reported at rates of 6.71, 7.75, and 7.35 episodes per person per year respectively. A short-term blood sugar marker called 1,5-AG was also tracked; the before-meal LY900014 group showed an average change of +0.19 mg/L, the after-meal group −0.38 mg/L, and the standard insulin lispro group −0.22 mg/L. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03449433 · results posted 30 April 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03449433) enrolled 80 people across five groups: four groups of people with Type 1 diabetes (17, 16, 18, and 17 participants respectively) and one group of 12 healthy participants. The trial was comparing four different fast-acting insulin products — an investigational insulin called LY900014, a standard insulin lispro (Humalog®), and two insulin aspart products (NovoRapid® and Fiasp®). The study was looking at how these insulins move through the body (how much gets absorbed and over what time) and how blood sugar levels change after eating a mixed meal. The reported data shows that the primary measure — the total amount of insulin detected in the blood over seven hours — was 786 units (picomoles × hour per litre) for LY900014, 756 for Humalog®, 938 for NovoRapid®, and 928 for Fiasp®. For the secondary measure — how much blood sugar rose above baseline over five hours after a meal — the reported figures were 81.5 units (milligrams × hour per decilitre) for LY900014, 141 for Humalog®, 157 for NovoRapid®, 101 for Fiasp®, and 44.1 for the healthy participants group. These numbers simply describe what was measured and recorded; they do not on their own tell us whether one insulin is better or worse than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03020069 · results posted 16 March 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03020069) enrolled 13 young people (children or adolescents) with diabetes. Nine were given a glucose meter to use, and four were not. All nine in the glucose meter group completed the trial, while three of the four in the no-glucose-meter group completed it. The trial was measuring four things over a three-month period: diabetes-related quality of life (using a questionnaire called the PedsQL 3.2), a blood marker called HbA1c (which reflects average blood sugar levels over roughly two to three months), actual blood sugar levels, and a sense of confidence in managing diabetes (using a questionnaire called the DES-SF). The reported data shows the following changes from the start of the trial to three months later. On the quality-of-life questionnaire (scored 0–3,300, where higher means fewer problems), the glucose meter group's score went up by 6.4 points on average, while the no-glucose-meter group's score went down by 3.8 points. For HbA1c (measured in mmol/mol, where a lower number generally means lower average blood sugar), the glucose meter group's level dropped by 9.4 on average, and the no-glucose-meter group's level dropped by 36. For actual blood sugar levels (in mg/dL), the glucose meter group showed a change of −0.1 and the no-glucose-meter group showed no change (0). On the diabetes confidence questionnaire (scored 1–5), the glucose meter group's average score changed by +0.375, while the no-glucose-meter group's score changed by −0.25. It is worth noting that this was a very small trial with just 13 participants in total, which means the numbers reported here should be interpreted with considerable caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02227862 · results posted 9 March 2020

According to the results reported on ClinicalTrials.gov, this trial compared two insulin glargine products in people with diabetes: a version made by Mylan and the already-approved brand Lantus®. A total of 280 people were assigned to the Mylan insulin group and 278 to the Lantus® group, making 558 participants in all. The main thing being measured was the change in a blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over roughly three months) after 24 weeks. By the end of the study, 261 people in the Mylan group and 256 in the Lantus® group had completed the trial. The reported data shows that, for the primary outcome, HbA1c changed by 0.14% in the Mylan group and 0.11% in the Lantus® group over 24 weeks. For the secondary outcomes, the reported data shows a range of other measurements were also tracked. Changes in fasting blood sugar levels (measured in mmol/L, a standard blood glucose unit) were reported as −0.81 mmol/L for the Mylan group and +0.09 mmol/L for the Lantus® group at one time point. Self-monitored blood glucose readings at eight points across the day showed small changes in both groups. Daily insulin dose per kilogram of body weight increased slightly in both groups over time. The rate of low blood sugar episodes (hypoglycaemia) per 30 days was also tracked; the reported figures were negative numbers for both groups at both time points, which the data presents as changes from an earlier baseline rate, though the full context for those numbers was not provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00419562 · results posted 18 February 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 560 people in total — 283 who received 7.5 mg oral insulin capsules and 277 who received a placebo (dummy) capsule. Around 250 and 246 people respectively completed the study. The trial was measuring how often type 1 diabetes was diagnosed over time in people who were considered to be at risk of developing it. Participants were divided into groups called "strata" based on their level of risk, and the main number tracked was the rate at which diabetes was diagnosed per year of follow-up. The reported data shows that in the main group being studied (called the "primary stratum"), the rate of type 1 diabetes diagnosis was 0.088 per year in the oral insulin group compared with 0.102 per year in the placebo group. For a secondary higher-risk group (stratum 2), the reported rates were 0.181 per year for oral insulin and 0.341 per year for placebo. For another secondary group (strata 3 and 4 combined), the reported rates were 0.051 per year for oral insulin and 0.047 per year for placebo. These figures represent the proportion of participants per year in each group who were diagnosed with type 1 diabetes during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03260868 · results posted 7 January 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03260868) compared two ways of running a clinical study — a "virtual" approach (conducted remotely) versus a "traditional" approach (in-person) — in people with diabetes. A total of 15 people started the trial across both groups (8 in the virtual group and 7 in the traditional group), though only 9 completed it (5 virtual, 4 traditional). The trial's main focus was on measuring a blood sugar marker called HbA1c — a measure of average blood sugar levels over roughly three months — at 24 weeks, along with several other measures tracked along the way. The reported data shows that, for the primary measure (change in HbA1c at 24 weeks), the virtual group's HbA1c changed by +0.10 percentage points from their starting level, while the traditional group's changed by +0.33 percentage points — meaning both groups' HbA1c readings were slightly higher at 24 weeks than at the start. At the 16-week mark, a similar pattern was reported: +0.23 percentage points for the virtual group and +0.45 for the traditional group. For fasting plasma glucose (a measure of blood sugar after not eating), the reported data shows more variation: at 16 weeks, the virtual group's levels changed by −0.660 mmol/L and the traditional group's by −0.200 mmol/L; at 24 weeks, the virtual group's changed by −3.625 mmol/L and the traditional group's by +2.900 mmol/L. For the remaining secondary outcomes — including participant satisfaction, work productivity, and overall study experience questionnaires — no numerical results were reported in the data submitted to ClinicalTrials.gov. It is worth noting that this was a very small trial, and several participants did not complete it, so the numbers above are based on a limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03015220 · results posted 30 December 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 458 adults across four groups: three groups received different doses of an oral (tablet) form of semaglutide — 3 mg (131 people), 7 mg (132 people), or 14 mg (130 people) — and a fourth group of 65 people received an injectable medicine called dulaglutide (0.75 mg). The trial ran for 52 weeks of treatment plus a 5-week follow-up period. The primary thing researchers tracked was the total number of unwanted medical events (called adverse events) that occurred while participants were on treatment. Secondary measurements included changes in blood sugar control (using a measure called HbA1c — a percentage that reflects average blood sugar over roughly three months), fasting blood sugar levels, blood sugar readings at seven points throughout the day, blood sugar rises after meals, and body weight. The reported data shows that the total number of treatment-related adverse events recorded were 330 in the 3 mg group, 350 in the 7 mg group, 324 in the 14 mg group, and 178 in the dulaglutide group. For blood sugar control (HbA1c), the reported changes from the starting point at 26 weeks were −1.1%, −1.7%, −2.0%, and −1.6% for the four groups respectively; at 52 weeks these figures were −0.8%, −1.4%, −1.8%, and −1.4%. Fasting blood sugar levels (measured in mmol/L, a standard unit for blood sugar) also showed reductions across all groups at both 26 and 52 weeks, with the largest reported reductions in the 14 mg semaglutide group (−2.72 mmol/L at week 26; −2.18 mmol/L at week 52). Similarly, the average blood sugar reading across seven daily time points decreased in all groups at both timepoints, ranging from −1.8 to −3.5 mmol/L at week 26 and −1.7 to −3.3 mmol/L at week 52. Blood sugar rises after meals also decreased across groups. For body weight, the reported changes at 52 weeks were 0.0 kg (3 mg), −0.9 kg (7 mg), −1.7 kg (14 mg), and +1.0 kg (dulaglutide). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00786825 · results posted 18 December 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people in total — 5 in a group that received somatostatin (a substance used in the study to help control certain hormone levels) and 5 described as healthy controls (people without the condition being studied, used as a comparison group). All 10 participants completed the trial with none dropping out. The trial was measuring something called "brain glycogen turnover rate" — in plain terms, this is the speed at which the brain breaks down and rebuilds its stored sugar (glycogen), measured in milligrams per kilogram of body weight per minute. The reported data shows that the brain glycogen turnover rate in the somatostatin group was measured at 0.31 mg/kg/min, while the healthy controls group recorded a rate of 0.28 mg/kg/min. Only this one primary outcome measure was included in the submitted results data. No secondary outcome measures were reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01753362 · results posted 17 December 2019

According to the results reported on ClinicalTrials.gov, this trial involved 84 people in total — 36 received a placebo (an inactive treatment) and 48 received a medicine called liraglutide. The trial ran for 26 weeks and was mainly measuring changes in HbA1c, which is a blood test that gives an average picture of blood sugar levels over roughly the previous two to three months. A secondary measurement looked at average daily glucose (blood sugar) levels. The reported data shows that for HbA1c, the placebo group started at 7.77% and finished at 7.64% — a small decrease of about 0.13 percentage points. The liraglutide group started slightly higher at 7.94% and finished at 7.60% — a decrease of about 0.34 percentage points. For average daily blood sugar levels (measured in mg/dL, a standard unit for blood sugar), the placebo group went from 183 at the start to 172 at 26 weeks, while the liraglutide group went from 173 at the start to 171 at 26 weeks. Not all participants finished the trial — 10 people in the placebo group and 8 in the liraglutide group did not complete it, though the reasons were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02737722 · results posted 19 November 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02737722) involved 30 people in total who had diabetic foot ulcers. Participants were divided into four groups: 8 people received a low dose (0.1%) of a gel called Bisphosphocin Nu-3, 8 received a medium dose (1%), 8 received a high dose (2%), and 6 received a placebo (an inactive gel). All but one participant — who was in the 2% group — completed the study. The trial was measuring things like unwanted side effects, changes in bacterial cultures taken from the ulcers, ulcer severity scores, wound infection scores, and changes in ulcer size. The reported data shows that for the primary outcome looking at treatment-related side effects, zero participants in any of the four groups recorded any such events. For the bacterial culture results, the data as submitted to ClinicalTrials.gov was not presented in a fully labelled way for the 0.1% group, so those figures cannot be clearly reported here. For the other groups at various time points during the study, the numbers of participants with abnormal versus normal cultures varied across visits. On the secondary outcome measures, the reported data shows average changes in ulcer severity scores across all groups were small, ranging from a change of +0.13 (a slight increase in severity) in the 0.1% group to −0.33 (a slight decrease) in the placebo group on a scale of 0 to 4. For the wound infection score (which runs from 0 to 19), all groups showed average decreases, ranging from −1.50 in the 1% group to −3.00 in the placebo group. Ulcer area reductions were also reported across all groups, with the percentage reduction in ulcer area ranging from an average of 10.8% in the 1% group to 54.0% in the 2% group, and 41.0% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02531035 · results posted 19 November 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02531035) enrolled 1,405 people with type 1 diabetes — 705 in the placebo group and 700 in the sotagliflozin 400 mg group. The trial was measuring whether, after 24 weeks, participants could reach a blood sugar control target (a measure called A1C below 7.0%) without experiencing a serious low blood sugar episode (severe hypoglycaemia) or a dangerous complication called diabetic ketoacidosis (DKA, a build-up of acids in the blood). It also tracked several other things, including overall blood sugar control, body weight, blood pressure, and insulin dose. The reported data shows that for the main goal — reaching the A1C target without either serious complication — 15.2% of participants in the placebo group met this combined target, compared with 28.6% in the sotagliflozin group. For the additional measures, the reported data shows that average A1C changed by −0.33 percentage points in the placebo group and −0.79 percentage points in the sotagliflozin group (a negative number means A1C went down from where it started). Body weight changed by +0.77 kg in the placebo group and −2.21 kg in the sotagliflozin group. Among participants who started with higher blood pressure (at or above 130 mmHg), systolic blood pressure (the top number in a blood pressure reading) changed by −5.7 mmHg in the placebo group and −9.2 mmHg in the sotagliflozin group. Finally, the average daily bolus insulin dose (the insulin taken around meals) changed by +6.62% in the placebo group and −5.71% in the sotagliflozin group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01881009 · results posted 14 November 2019

According to the results reported on ClinicalTrials.gov, this trial involved two separate phases. In the first phase, 16 people took part in an overnight inpatient stay lasting 22 hours, and all 16 completed it. In the second phase, 22 people took part in a six-day summer camp session, with 21 completing it and one not finishing. The trial was measuring how much time participants' blood sugar levels (tracked by a continuous glucose sensor) spent within certain target ranges overnight, comparing nights when a "closed loop" automated insulin system was used against nights when it was not (called "control nights"). The reported data shows the following numbers for the main (primary) measures: during the inpatient overnight phase, blood sugar readings were within the target range of 70–150 mg/dL (a common blood sugar target range) about 63% of the time. During the summer camp phase, blood sugar readings were in that same 70–150 mg/dL range about 66.4% of the time on closed loop nights, compared with about 50.6% of the time on control nights. For a secondary measure using a slightly wider target range of 70–180 mg/dL during the camp phase, the reported figures were approximately 79.9% of the time on closed loop nights versus 60.0% of the time on control nights. No other outcome figures were included in the data submitted to ClinicalTrials.gov, so no further numbers can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02733991 · results posted 6 November 2019

According to the results reported on ClinicalTrials.gov, this trial involved 153 participants in total — 76 in the treatment group and 77 in the control group. The trial was measuring blood sugar levels using a continuous glucose sensor, with a particular focus on how often participants experienced low blood sugar episodes (readings at or below 55 mg/dL, which is a level considered dangerously low). It also tracked how much time participants spent with very low blood sugar, and how much time they spent with blood sugar in a target range of 70–180 mg/dL. The reported data shows that, on average, participants in the treatment group experienced approximately 1.12 low blood sugar episodes per week, compared to 4.13 per week in the control group. For time spent with very low blood sugar, the treatment group averaged around 13 minutes per day, while the control group averaged around 60 minutes per day. Regarding time spent in the target blood sugar range, the treatment group averaged roughly 863 minutes per day (about 14.4 hours) and the control group averaged roughly 832 minutes per day (about 13.9 hours). The reported data covers only the numbers submitted to ClinicalTrials.gov, and what these figures mean in a broader sense — including any risks or benefits — was not assessed here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02397265 · results posted 1 November 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02397265) involved a total of 6 participants, divided into three groups of 2. It was a crossover study, meaning each participant went through all three approaches in sequence: a bihormonal closed loop system (an automated system using two hormones to manage blood sugar), a standard open loop insulin pump (where the person manages their own dosing), and an insulin-only approach. The trial was measuring the percentage of time participants spent with their blood glucose level within a target range of 3.9–10.0 mmol/L over a 24-hour period. The reported data shows the following average percentages of time spent within that target blood sugar range: the bihormonal closed loop group recorded 2%, the standard open loop pump group recorded 4.7%, and the insulin-only group recorded 1.3%. It is worth noting that only the primary outcome measure was reported in the submitted results, and no secondary outcome data was included — that information was not reported on ClinicalTrials.gov. Given that only 2 participants were in each group, these figures come from a very small number of people, and no further statistical context was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02421510 · results posted 30 October 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 782 people across three groups — 258 received a placebo (dummy treatment), 261 received sotagliflozin at a 200 mg daily dose, and 263 received sotagliflozin at a 400 mg daily dose. All participants had Type 1 diabetes and were already using insulin. The trial ran for 24 weeks and was primarily measuring changes in a blood sugar marker called HbA1c (a percentage figure that reflects average blood sugar levels over roughly three months — a lower number generally means lower average blood sugar levels). A number of secondary things were also measured, including body weight, insulin dose, fasting blood sugar levels, and how satisfied participants were with their diabetes treatment. The reported data shows that, for the main measure, average HbA1c changed by −0.02 percentage points in the placebo group, −0.39 percentage points in the 200 mg group, and −0.37 percentage points in the 400 mg group — all representing small reductions from where participants started, with the placebo group's change being very close to zero. For the secondary measures, the reported data shows that around 15% of placebo participants, 31% of 200 mg participants, and 32% of 400 mg participants reached an HbA1c below 7.0% without experiencing a severe low blood sugar episode or a serious complication called diabetic ketoacidosis. Body weight changed by +0.11 kg in the placebo group, −1.88 kg in the 200 mg group, and −2.47 kg in the 400 mg group. The amount of bolus (mealtime) insulin used per day fell by 1.19 units in the placebo group, 4.38 units in the 200 mg group, and 4.78 units in the 400 mg group. Fasting blood sugar levels rose by 8.8 mg/dL in the placebo group and fell by 12.8 mg/dL and 16.9 mg/dL in the 200 mg and 400 mg groups respectively. Treatment satisfaction scores (on a scale of 0–36) changed by −0.1 points in the placebo group, +1.9 points in the 200 mg group, and +1.6 points in the 400 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02383940 · results posted 30 October 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 44 people in the placebo group and 43 people in the sotagliflozin 400 mg group, for a total of 87 participants. The trial was measuring changes in blood sugar control over 12 weeks in people with diabetes who were also using insulin. The main thing being tracked was a blood test called HbA1c (a measure of average blood sugar levels over roughly three months), along with several other blood sugar-related measures. The reported data shows that, at week 12, both groups had lower HbA1c levels than when they started. On average, the placebo group's HbA1c fell by 0.99 percentage points, while the sotagliflozin group's fell by 1.33 percentage points. For blood sugar measured two hours after a standardised meal, the placebo group's reading changed by almost nothing (+0.2 mg/dL), while the sotagliflozin group's reading fell by 56.4 mg/dL on average. The reported data also shows changes in daily insulin doses: the sotagliflozin group reduced their mealtime (bolus) insulin by about 4.89 units per day on average, compared to about 2.96 units per day in the placebo group; background (basal) insulin changed by +3.26 units per day in the placebo group and +2.03 units per day in the sotagliflozin group. Regarding periods of high blood sugar tracked by a continuous glucose monitor, the sotagliflozin group showed a larger reported reduction. For low blood sugar episodes (readings at or below 70 mg/dL) measured by fingerstick, both groups showed very small changes — a reduction of about 0.042 episodes per day in the placebo group and 0.001 in the sotagliflozin group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02171130 · results posted 15 October 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02171130) enrolled 129 people with diabetes who were at risk of low blood sugar (hypoglycaemia) episodes. Of those, 87 actually received at least one dose of the nasal glucagon — a powder sprayed into the nose — and all 87 experienced a low blood sugar episode during the study period, which is when the treatment was used. The trial's main goal was to measure how often people woke up or returned to a normal state within 30 minutes of being given the nasal spray during a moderate or severe low blood sugar episode, with caregivers (such as family members or support people) answering questions to track this. The reported data shows that in 95.7% of the low blood sugar episodes treated with nasal glucagon, the person returned to a normal state or woke up within 30 minutes. Caregivers also completed questionnaires about how easy the device was to use; the reported data shows a spread of responses across a 1–7 scale (where 1 meant "very difficult" or "strongly disagree" and 7 meant "very easy" or "strongly agree"), though the detailed breakdown of each question is complex and not fully labelled in the submitted data. Blood sugar levels were also measured over time: the reported average readings were approximately 48 mg/dL just before the dose was given, rising to around 84 mg/dL at 15 minutes, 113 mg/dL at 30 minutes, and 123 mg/dL at 45 minutes after the dose. The reported data also shows that 82.8% of participants reported at least one nasal-related symptom (such as a runny nose, sneezing, or watery eyes) through a questionnaire — these were tracked as solicited events of interest. Additionally, the data shows that 0% of participants developed antibodies against the glucagon component of the treatment, meaning none of the tested participants showed that particular immune response. These numbers describe what was measured and recorded in this trial only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02199028 · results posted 11 October 2019

According to the results reported on ClinicalTrials.gov, this trial involved 30 people who used insulin pumps and were divided into two groups of 15. It used a "crossover" design, meaning each person tried both conditions at different times — one group started with Hylenex (a drug containing hyaluronidase, an enzyme) and then switched to the control (no hyaluronidase), while the other group did it in reverse order. The trial was measuring how long participants could wear their insulin infusion set (the small needle and tube that delivers insulin under the skin), as well as how blood sugar levels changed after meals and how much pain people felt at the injection site. The reported data shows that, on average, people wore their infusion set for 5.7 days when using hyaluronidase, compared to 5.4 days in the control condition. For blood sugar excursions after meals (a combined score measuring how high blood sugar rose and how quickly), the reported figures were 43.5, 36.9, and 56.4 mg/dL at various measured points for the hyaluronidase group, compared to 69.5, 72, and 51.6 mg/dL for the control group. The trial noted that a score below 80 mg/dL is generally considered acceptable for people with Type 1 diabetes. Regarding pain at the injection site, participants recorded their pain on a scale of 0 (no pain) to 5 (worst pain imaginable). The reported diary entries show 58 entries rated 0, 34 rated 1, 11 rated 2, 4 rated 3, and none rated 4 or 5. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03339453 · results posted 23 September 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT03339453) enrolled 70 adults in total, split into two groups of 35. It was a crossover study, meaning each participant received both treatments at separate visits — one group received nasal glucagon first and then an injected (intramuscular) form of glucagon, while the other group received them in the opposite order. The trial was measuring how well each form of glucagon raised blood sugar levels during a controlled episode of low blood sugar (hypoglycaemia) that was deliberately brought on as part of the study. "Treatment success" was defined as blood sugar rising to at least 70 mg/dL, or rising by at least 20 mg/dL from its lowest point, without needing any extra steps to raise blood sugar. The reported data shows that for the primary outcome — the number of participants considered to have achieved "treatment success" — 66 out of 66 participants met the definition for the nasal glucagon, and 66 out of 66 participants met the definition for the injected glucagon. For secondary outcomes, the reported data shows the maximum rise in blood glucose was 132 mg/dL for nasal glucagon and 161 mg/dL for injected glucagon. The time it took for blood glucose to reach its peak was reported as 1.00 hour for nasal glucagon and 1.50 hours for injected glucagon. On measures of how much glucagon was absorbed into the bloodstream over time, nasal glucagon recorded a value of 2,740 and injected glucagon recorded 3,320 (in standard measurement units). The peak glucagon level in the blood was reported as 6,130 for nasal glucagon and 3,750 for injected glucagon, and the time taken to reach that peak was the same for both — 0.25 hours (about 15 minutes). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02024750 · results posted 18 September 2019

According to the results reported on ClinicalTrials.gov, this trial involved 214 participants in total — 106 in the "Tailored Resources" group (who received a personalised information intervention) and 108 in the "Usual Care" group (who received standard care). The study was focused on children with diabetes and their parents, and it tracked three main things over time: blood sugar control (measured using a test called HbA1c, which gives an average of blood sugar levels over a few months), quality of life for the children, and quality of life for the parents. A secondary measure looked at how worried parents were about their child experiencing a low blood sugar episode (hypoglycaemia). Almost all participants completed the study — 104 in the Tailored Resources group and 107 in the Usual Care group. The reported data shows that for blood sugar control (HbA1c), both groups showed a very small upward trend (meaning levels were slowly rising) during the intervention period — 0.014 percentage points per month for Usual Care and 0.018 for Tailored Resources. After the intervention ended, the Usual Care group's rate of change was reported as 0.035 per month, compared to 0.025 for the Tailored Resources group. For children's quality of life (scored out of 100, where higher is better), both groups showed a slowly improving trend during the intervention (0.194 per month for Usual Care and 0.217 for Tailored Resources), but after the intervention, both trends slowed considerably (0.083 for Usual Care and 0.010 for Tailored Resources). For parents' quality of life, during the intervention Usual Care showed a rate of 0.115 per month and Tailored Resources 0.078; after the intervention, both were similar at 0.182 and 0.172 respectively. The reported data shows that for parents' worry about low blood sugar episodes, during the intervention the Usual Care group showed a slight decrease in worry (−0.088 per month) while the Tailored Resources group showed a slight increase (0.046 per month). After the intervention, both groups showed a small decrease in worry (−0.074 for Usual Care and −0.080 for Tailored Resources). It is worth noting that all of these monthly changes are very small numbers relative to the overall scales used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01534013 · results posted 28 August 2019

According to the results reported on ClinicalTrials.gov, this trial compared two approaches to delivering insulin in people with diabetes: a "closed-loop" system (where a device automatically adjusts insulin delivery based on continuous glucose readings) and an "open-loop" system (where insulin delivery is managed in the more traditional way, without that automatic adjustment). A total of 14 people were enrolled — 8 in the closed-loop group and 6 in the open-loop group. Of those, 12 completed the study (6 in each group), while 2 people in the closed-loop group did not complete it. The trial's main focus was on how much time participants spent with their blood sugar in a healthy range (called "euglycaemia"). The reported data shows that, for the primary outcome, participants in the closed-loop group spent an average of 71% of the monitored time with their blood sugar in the healthy range, while those in the open-loop group spent an average of 66.9% of the time in that range. For all of the secondary outcomes — including time spent with blood sugar too low (hypoglycaemia), time spent with blood sugar too high (hyperglycaemia), measures of how much blood sugar levels varied, and measures of blood sugar risk — no numerical results were reported in the data submitted to ClinicalTrials.gov. It is worth noting that this was a small trial with only 14 participants across both groups, so the reported numbers reflect a limited sample. The data was not reported for most of the secondary measures, so a full picture of what was tracked cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02299050 · results posted 21 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people with type 2 diabetes whose blood sugar levels were not well controlled despite already taking one of two injectable diabetes medications (Bydureon or Victoza). The trial looked at whether adding a medicine called Cycloset (bromocriptine) to their existing treatment made any difference to their blood sugar levels and a range of other body measurements. Of the 23 people who started the trial, 15 completed it and 8 did not finish. The reported data shows that the main blood sugar measure — HbA1c, a test that reflects average blood sugar over roughly three months — was recorded at 8.3 mmol/mol at the start and 7.7 mmol/mol at a later point for participants in the Cycloset group. A second primary measure looked at how the body processed glucose during a meal test, recorded as 1.1 mg/kg\*min at the start and 0.7 mg/kg\*min at a later point. For the secondary measures, pulse pressure (a marker related to blood vessel function) was reported as 54 mmHg at the start and 51 mmHg later; body weight was reported as 88.1 kg at the start and 87.1 kg later; and percentage body fat was 39.1% at the start and 39.3% later. Blood pressure readings were reported as 134/78 mmHg at the start and 126/73 mmHg at a later point. The reported data does not include details about the timing of these measurements or the number of participants included in each individual measurement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01483560 · results posted 3 June 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01483560) enrolled 428 people — 219 in the metformin group and 209 in the placebo group. By the end of the study, 193 people in the metformin group and 194 in the placebo group had completed it. The trial was measuring whether metformin, a medicine commonly used in type 2 diabetes, had any effect on the thickness of the wall of a major artery in the neck (called the carotid artery) — a measurement sometimes used to track blood vessel changes over time. Several other things were also tracked, including blood sugar control, cholesterol, kidney function, eye changes, and body weight. The reported data shows that artery wall thickness (measured in millimetres) started at around 0.773 mm in the metformin group and 0.791 mm in the placebo group, and by 36 months had reached 0.793 mm and 0.820 mm respectively. For blood sugar control (measured as HbA1c — a percentage that reflects average blood sugar over roughly three months), both groups started at around 8.0–8.1% and finished at similar levels. The reported data shows LDL cholesterol (a type of fat in the blood) started at similar levels in both groups and finished at 2.07 mmol/L in the metformin group and 2.21 mmol/L in the placebo group. A measure of kidney filtering ability started at 92.9 and 91.1 in the two groups respectively, finishing at 92.1 and 87.2. For eye (retina) changes, 8 out of 191 participants in the metformin group and 10 out of 190 in the placebo group showed a meaningful worsening in a specific eye grading scale over 36 months. Body weight in the metformin group went from an average of 83.9 kg to 82.0 kg, while the placebo group went from 83.5 kg to 83.2 kg. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02984709 · results posted 24 April 2019

According to the results reported on ClinicalTrials.gov, this trial involved 48 young people with diabetes, split into two groups of 24. One group took part in a **Positive Psychology Intervention** — a programme focused on building positive thinking and emotional skills — while the other group received a standard **diabetes education programme**. All 48 participants who started the trial completed it. The trial was primarily looking at blood sugar control (measured by a test called A1C, which gives an average picture of blood sugar levels over the previous two to three months), and also tracked a range of other things including mood, how often participants checked their blood sugar, family arguments about diabetes management, quality of life, and how they coped with diabetes-related stress. The reported data shows that, for the main measure, the Positive Psychology group had an average A1C of 8.60% compared to 9.35% in the education group. For the other measures: positive mood scores (on a scale of 15–60, where higher means more positive) were 40.6 for the Positive Psychology group and 42.8 for the education group. Blood sugar checking frequency was 3.8 times per day for the Positive Psychology group and 3.2 times per day for the education group. Family conflict around diabetes (on a scale of 19–57, where higher means more conflict) was reported at two points in time — the Positive Psychology group scored 30 then 23.8, while the education group scored 36 then 30.4. Diabetes-related quality of life scores (on a scale of 0–100, higher being better) were 71 for both groups. For coping style, the ratio scores for "primary control coping" (such as problem-solving) were 0.18 for the Positive Psychology group and 0.20 for the education group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03028220 · results posted 16 April 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT03028220) enrolled 40 adults in total, split evenly into two groups of 20. One group used Real Time Continuous Glucose Monitoring (a device that automatically checks blood sugar levels continuously and alerts the user), and the other used Flash Glucose Monitoring (a device where the user scans a sensor to get a reading). All 40 participants completed the trial. The trial was measuring changes in the amount of time participants spent with blood sugar levels that were too low (hypoglycaemia), in a healthy range, or too high (hyperglycaemia), comparing where each person started to where they ended up. The reported data shows the following changes in time spent at various blood sugar levels. For the primary measure — time spent with very low blood sugar (below 3.3 mmol/L) — the Real Time Continuous Glucose Monitoring group saw a change of −3.0 percentage points (meaning they spent less time at that level compared to their starting point), while the Flash Glucose Monitoring group saw a change of +1.3 percentage points. For an even lower blood sugar threshold (below 2.8 mmol/L), the reported changes were −1.2 percentage points for the Real Time group and +1.3 percentage points for the Flash group. For a slightly higher low blood sugar threshold (below 3.9 mmol/L), the changes were −2.7 and +0.6 percentage points respectively. Regarding time spent in a healthy blood sugar range, the Real Time group showed changes of +10.6 percentage points (range 3.9–7.8 mmol/L) and +12.7 percentage points (range 3.9–10 mmol/L), compared with +5.9 and +5.3 percentage points for the Flash group. For time spent with high blood sugar (above 10 mmol/L), the reported changes were −8.6 percentage points for the Real Time group and −7.0 percentage points for the Flash group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02284009 · results posted 25 March 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02284009) enrolled 67 people in total — 17 in the placebo group and 50 in the albiglutide group. Of those, 11 and 40 respectively completed the study. The trial was looking at whether albiglutide, a weekly injectable medicine, affected the body's remaining ability to produce insulin in people with recently diagnosed type 1 diabetes. The main thing being measured was a substance called C-peptide — a marker in the blood that reflects how much insulin the pancreas is still making on its own — assessed at 52 weeks using a standardised meal test. The reported data shows that for the primary outcome, both groups saw a small decline in C-peptide levels from their starting point by week 52. The placebo group's average change was −0.16 nanomoles per litre, while the albiglutide group's average change was −0.13 nanomoles per litre. A third reference group from a related study (DEFEND-1 placebo) showed a change of −0.27 nanomoles per litre. For the secondary outcomes, the reported data shows that by week 64, both groups had similar average changes in C-peptide (−0.22 nanomoles per litre each). Glucagon — a hormone that raises blood sugar — appeared to change differently between the groups at various time points, though the reported figures varied across the measurement visits. The percentage of participants meeting certain blood sugar and insulin-use targets, and those considered to be in a "partial remission" phase of their diabetes, also shifted over time in both groups, with the reported numbers for both groups broadly similar across most time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01771250 · results posted 11 March 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people in total across two groups. It used a "crossover" design, meaning participants tried both treatments — one called insulin peglispro (also known as LY2605541) and one called insulin glargine — in two separate periods. One participant did not receive any study drug in the first period, so 14 people completed the full trial. The trial was measuring how each insulin affected fat particles called VLDL-triglycerides (a type of fat carried in the blood), specifically looking at their concentration in the blood, how fast they were being produced, how fast they were being broken down for energy, and how fast they were being cleared from the blood. The reported data shows the following numbers at steady state (meaning once the body had settled into a stable pattern with each insulin). For VLDL-triglyceride concentration in the blood, the reported average was 0.27 µmol/L with insulin peglispro and 0.17 µmol/L with insulin glargine. For the rate at which these fat particles were being produced (secretion rate), the reported figures were 38.79 µmol/min with insulin peglispro and 25.61 µmol/min with insulin glargine. For the rate at which they were being burned for energy (oxidation rate), the reported figures were 20.13 µmol/min with insulin peglispro and 15.34 µmol/min with insulin glargine. For the rate at which they were being cleared from the blood (clearance rate), the reported figures were 142.16 mL/min with insulin peglispro and 155.11 mL/min with insulin glargine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02109029 · results posted 6 March 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02109029) involved a total of 24 participants split across two parts. Part A included 12 people who were assigned to different dose groups of an experimental insulin called insulin peglispro. Part B included 12 people who were split into two groups of 6, with each group receiving both insulin peglispro and a standard human insulin at different times (a "crossover" design, meaning each person tried both). The trial was measuring how these insulins moved through the body — specifically, how much of each insulin ended up in the fluid surrounding fat tissue (called interstitial fluid, or ISF) compared to the bloodstream. The reported data shows two primary measurements, both from Part B. The first looked at the steady-state concentration — that is, the stable level reached after repeated dosing — of each insulin in the fat tissue interstitial fluid. The reported figure for insulin peglispro was 11,200 picomoles per litre (a picomole is an extremely tiny unit of measurement), compared to 425 picomoles per litre for human insulin. The second measurement looked at the absolute concentration of each insulin in the same fat tissue fluid. The reported figure for insulin peglispro was 1,428.4 picomoles per litre, compared to 137.9 picomoles per litre for human insulin. No outcome data was reported for Part A of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01868594 · results posted 4 March 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 151 adults — 76 in the Subetta group and 75 in the placebo group. Most participants completed the trial (72 in each group). The trial was measuring changes in blood sugar control in people with type 2 diabetes who were already using insulin. The main thing being tracked was a blood test called HbA1c — a measure of average blood sugar levels over roughly three months, expressed as a percentage. A number of secondary measures were also tracked, including fasting blood sugar, daily blood sugar readings taken by participants at home at seven points throughout the day, blood fats (cholesterol and triglycerides), and insulin doses. The reported data shows that, for the primary measure (HbA1c), the Subetta group's average HbA1c fell by figures ranging from −0.59 to −0.71 percentage points across the time points reported, while the placebo group's average fell by figures ranging from −0.20 to −0.49 percentage points. For fasting blood sugar, the reported data shows the Subetta group's readings changed by between −0.5 and −0.8 mmol/L across time points, while the placebo group's readings changed by between +0.3 and +1.1 mmol/L. For the seven-point home blood sugar monitoring, changes in both groups were small, ranging from 0.0 to −0.3 mmol/L in the Subetta group and from −0.2 to +0.1 mmol/L in the placebo group. For blood fats, the reported changes were also small and broadly similar across both groups. For insulin doses, the reported data shows small changes in both groups across basal, prandial, and total daily doses, with the total dose in the Subetta group reported as changing by −1.2 IU and in the placebo group by 0.0 IU; total insulin by body weight changed by −0.02 IU/kg in the Subetta group and −0.01 IU/kg in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02152384 · results posted 1 March 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02152384) involved 28 participants in total — 14 in each of two groups. It used a "crossover" design, meaning each person received both treatments at different times: one group started with insulin peglispro (also called LY2605541) and then switched to insulin glargine, while the other group did the reverse. The trial was measuring how the body responded — in terms of blood sugar levels and how insulin moved through the body — when people took different doses of a mealtime insulin (insulin lispro) alongside each of these two background insulins. A small number of participants (three in total) did not complete the first treatment period, but all who moved into the second period finished it. The reported data shows that the main thing being measured was the rise in blood sugar after a meal, tracked over five hours, at five different doses of mealtime insulin. At the lowest mealtime insulin dose (25% of a person's normal dose), the reported blood sugar rise was 677.84 units for the insulin peglispro group and 716.52 units for the insulin glargine group. At the highest dose (150% of normal), those figures were 174.38 and 123.97 units respectively (measured in mg\*h/dL — a way of capturing how high and for how long blood sugar was elevated). The reported data also shows that the amount of mealtime insulin detected in the bloodstream over five hours was very similar between the two groups (850 vs 852 pmol\*h/L). Separately, a "clamp" procedure — a controlled test used to measure how sensitive the body is to insulin — recorded average glucose infusion rates of 52.8 vs 56.3 (high-dose step) and 13.9 vs 18.8 (low-dose step), measured in µmol/kg/min for the peglispro and glargine groups respectively. The reported data also includes some additional measurements. Appetite and hunger ratings, scored on a scale of 0–100, were reported across several questions; scores for the peglispro group generally ranged from about 27 to 56, and for the glargine group from about 32 to 59, with the glargine group tending to score slightly higher on most measures (higher scores indicating more hunger or larger perceived appetite). Paracetamol levels in the blood — used in this type of trial as an indirect measure of how quickly food moves through the stomach — were 33,400 vs 33,600 ng\*hr/mL, and triglyceride levels after the meal were 6.85 vs 6.01 ng\*hr/mL for the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01857973 · results posted 28 February 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 78 participants, all of whom used a hybrid closed-loop insulin delivery system — a type of automated pump that adjusts insulin based on continuous glucose sensor readings. The trial was divided into several phases, each testing the system under different conditions such as missed meal doses, exercise, and other real-world challenges. Of the 78 who started, 73 completed the trial. The main thing being measured across the phases was the percentage of time participants' glucose levels stayed within a target range of 70–180 mg/dL (milligrams per decilitre), which is generally considered a healthy blood sugar range for people with diabetes. The reported data shows the following results across the different phases. In the primary measure — Phase 3, which used the Next Generation Pump platform over 12 days in a monitored clinic or house setting — participants spent an average of 69.3% of the time within the target glucose range. In the earlier Exploratory A phase (an overnight test), that figure was reported as 90.7%. Phase 2 recorded 65.8% of time in range, while Phase 4 recorded 76.1%. In the Exploratory B phase, which tested a feature designed to prevent very low blood sugar (below 50 mg/dL) by capping insulin delivery, the reported data shows that 5 out of 9 participants still had a glucose reading dip below that level. In Phase 1, 13 out of 17 participants were deliberately given an inaccurate sensor reading as part of a test of the system's response to sensor errors. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03662334 · results posted 1 February 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT03662334) looked at whether adding an enzyme called hyaluronidase to insulin delivered by a continuous pump (a small device worn on the body that delivers insulin through the skin) would change how quickly the insulin acted. The trial was designed in three parts, but the reported data shows that only Part 2 enrolled any participants — 7 people in each of the two groups, for 14 participants in total. The other two parts (Part 1 and Part 3) recorded zero participants started or completed, so no results from those parts were reported. The reported data shows that Part 2 was measuring how long it took for blood sugar levels to fall by 80 mg/dL (a unit used to measure the amount of sugar in the blood) after an insulin dose was given. According to the results reported on ClinicalTrials.gov, the trial was stopped earlier than planned because it proved difficult to maintain a stable, elevated blood sugar level during the procedure — a technical requirement for the test to work properly. Because of this early stop, only 14 of the intended 24 participants were enrolled, and a full statistical analysis was not carried out. Instead, the data reported shows only the longest time it took for any single participant to reach that blood sugar drop: in the group that received hyaluronidase first, the maximum times recorded across the two treatment periods were 5.58 hours and 4.63 hours; in the group that received the sham (dummy) injection first, the maximum times were 5.23 hours and 5.32 hours. No results were reported for the primary or secondary outcome measures relating to Parts 1 and 3. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02372253 · results posted 30 January 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people in total — 13 in the verapamil group and 13 in the placebo group. Two people in the verapamil group did not complete the trial, while everyone in the placebo group finished. The trial was measuring whether taking verapamil daily for 12 months had any effect on the body's remaining insulin-producing capacity in people with type 1 diabetes. The main thing being measured was a substance called C-peptide, which acts as a signal of how much insulin the body is still producing on its own. The reported data shows that after 12 months, the verapamil group had a C-peptide reading of 0.74 nmol/L, compared with 0.46 nmol/L in the placebo group. For the secondary measurements — things tracked alongside the main goal — the reported data shows that the verapamil group's external insulin needs (injected insulin) rose by around 27% from where they started at 12 months, while the placebo group's rose by around 70%. At 12 weeks, those figures were 5.9% and 26.0% respectively. A blood sugar control marker called HbA1c (a percentage that reflects average blood sugar levels over time) was reported as 6.4% for verapamil and 6.9% for placebo at 12 months, and 6.0% versus 6.6% at 12 weeks. Low blood sugar episodes were reported at 0.55 events per month in the verapamil group and 2.72 events per month in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02660827 · results posted 11 January 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 151 participants who were children aged 2 to 13 years old with diabetes, and all of them used a device called the MMT-670G insulin pump (an automated insulin delivery system). Of the 151 who started, 150 completed the main three-month study period. A second, optional continuation phase was also offered; 145 participants entered it and 120 finished it. The trial was mainly measuring changes in a blood sugar control marker called A1C (a blood test that gives an average picture of blood sugar levels over roughly three months), as well as how much time participants spent with their blood sugar in different ranges. The reported data shows that, on average, participants' A1C levels changed by −0.37 percentage points from the start to the end of the three-month study period — meaning the average reading was lower at the end than at the beginning. For the secondary measures, the reported data shows the average time spent with blood sugar in the target range (70–180 mg/dL, sometimes called the "in-range" zone) increased by 8.58 percentage points. The average time spent with blood sugar above that range (above 180 mg/dL, known as high blood sugar or hyperglycaemia) decreased by 7.39 percentage points. The average time spent with blood sugar below 70 mg/dL (low blood sugar, or hypoglycaemia) decreased by 1.19 percentage points. The reported data also shows that zero severe low blood sugar events and zero episodes of a serious complication called diabetic ketoacidosis (DKA) were recorded during the three-month study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02673138 · results posted 29 November 2018

According to the results reported on ClinicalTrials.gov, 10 people took part in this trial and all 10 completed it. The trial was looking at what happens to certain substances in the blood when a person's insulin pump is paused — once while taking insulin alone, and once while also taking a medication called canagliflozin (a type of diabetes tablet). The researchers measured blood glucose (blood sugar), a substance called beta-hydroxybutyrate (BHB, which the body produces when it breaks down fat for energy instead of sugar), free fatty acids (fats released into the blood), and glucagon (a hormone that raises blood sugar). The reported data shows that when insulin was paused without canagliflozin, the average blood glucose reading was 197 mg/dL, compared with 99 mg/dL when canagliflozin was also being taken. For BHB, the reported average was 1.2 mmol/L without canagliflozin and 1.5 mmol/L with canagliflozin. For free fatty acids, the reported figures were 0.8 mmol/L without canagliflozin and 0.7 mmol/L with canagliflozin — a very small numerical difference. For glucagon, the reported average was 14 pg/mL without canagliflozin and 36 pg/mL with canagliflozin. The reported data shows these numbers as averages across the 10 participants under the two different conditions. No further details about the spread of individual results or statistical analysis were included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02502071 · results posted 20 November 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02502071) involved 45 participants, all of whom completed the study with no drop-outs. Every participant received sodium bicarbonate. The trial was measuring two things related to uric acid in urine — uric acid is a natural waste product that can sometimes form crystals in the body. Specifically, the study looked at the concentration (amount) of uric acid in urine, and how many participants had visible uric acid crystals present in their urine samples. The reported data shows that urine uric acid concentration was measured at two points, with figures of 23.81 mg/dl and 22.30 mg/dl recorded for the group. Regarding uric acid crystals detected under a specialised microscope, the reported data shows that 14 participants had crystals present at one measurement point, compared to 3 participants at another measurement point. The data does not include labels clarifying which of these figures represent measurements taken before versus after the intervention, so the precise timing of each reading cannot be confirmed from the information provided. It is worth noting that the reported data does not include a comparison group (sometimes called a control or placebo group), which means these numbers reflect only the single group that received sodium bicarbonate. No additional detail about side effects or other outcomes was included in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02414958 · results posted 20 November 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 730 people in total — 243 received a placebo (a dummy pill), 243 received empagliflozin at a 10 mg dose, and 244 received empagliflozin at a 25 mg dose. The trial ran for 26 weeks and was primarily measuring changes in a blood sugar marker called HbA1c (glycated haemoglobin), which reflects average blood sugar levels over roughly two to three months. It also tracked things like episodes of low blood sugar, body weight, and how much time participants spent with their blood sugar in a target range. The reported data shows that, at 26 weeks, the adjusted average HbA1c level rose slightly in the placebo group (by about +0.09 percentage points), while it fell by about 0.44 percentage points in both the 10 mg and 25 mg empagliflozin groups. For body weight, the placebo group showed an adjusted average change of roughly −0.1 kg, compared with −2.79 kg in the 10 mg group and −3.37 kg in the 25 mg group. Regarding low blood sugar episodes (confirmed by a blood sugar reading below a set threshold), the reported rate per patient-year from week 5 to 26 was approximately 8.92 for the placebo group, 6.64 for the 10 mg group, and 6.48 for the 25 mg group. For time spent in the target blood sugar range (measured over weeks 23–26), the placebo group showed an adjusted average change of −1.13 percentage points, while the 10 mg group showed +10.73 and the 25 mg group showed +11.74 percentage points. The reported data also shows that the spread of blood sugar fluctuations (measured by a continuous glucose monitor) changed over weeks 23–26: the placebo group's fluctuations increased slightly (by about +1.62 mg/dL on the scale used), while the 10 mg group's fell by about 15.30 mg/dL and the 25 mg group's fell by about 17.41 mg/dL. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03091673 · results posted 16 November 2018

According to the results reported on ClinicalTrials.gov, this trial involved 31 children and teenagers with diabetes who received a glucagon injection called G-Pen. The trial was split into two dosing stages: 31 participants received a 0.5 mg dose in the first stage, and 11 participants received a 1.0 mg dose in the second stage. The children were grouped into three age bands — 2 to under 6 years, 6 to under 12 years, and 12 to under 18 years. The main thing the trial was measuring was how much blood sugar levels changed after the injection, with a particular focus on the change seen 30 minutes after dosing. The reported data shows that, on average, blood sugar levels rose by 81.4 mg/dL in the youngest age group (2 to under 6 years), by 84.2 mg/dL in the middle age group (6 to under 12 years), and by 54.0 mg/dL in the oldest age group (12 to under 18 years) over that 30-minute window. The reported data also shows how quickly blood sugar rose by at least 25 mg/dL from the starting level — this took an average of around 16 minutes in the two younger groups and about 27 minutes in the oldest group. Researchers also tracked how the glucagon medication itself moved through the body over time; the peak level of glucagon recorded in the blood was around 199–216 mg/dL across all age groups, and the time it took to reach that peak ranged from roughly 67 minutes in the youngest group to about 81 minutes in the oldest group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02580591 · results posted 2 November 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02580591) enrolled 977 people in total, spread across four groups: one group received a placebo (a dummy pill with no active ingredient), and the other three groups received different doses of empagliflozin — 2.5 mg, 10 mg, or 25 mg. All participants already had type 1 diabetes and were using insulin. The trial ran for 26 weeks and was primarily measuring changes in a blood sugar marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly three months — as well as a number of secondary measures including body weight, blood pressure, insulin dose, and rates of low blood sugar episodes. The reported data shows that, after 26 weeks, the placebo group's HbA1c figure rose slightly (by around 0.20–0.21 percentage points on average), while the empagliflozin groups showed average reductions: approximately 0.09–0.06 percentage points in the 2.5 mg group, 0.25–0.23 percentage points in the 10 mg group, and 0.33–0.30 percentage points in the 25 mg group (two slightly different analysis methods produced the small ranges shown). For body weight, the placebo group averaged a gain of about 0.21 kg, while the empagliflozin groups averaged losses of approximately 1.55 kg (2.5 mg), 2.83 kg (10 mg), and 3.22 kg (25 mg). For blood pressure, the reported data shows the placebo group had little to no change, while the empagliflozin groups showed modest average reductions in systolic pressure (the top number) of roughly 1.7 to 3.5 mmHg, and in diastolic pressure (the bottom number) of roughly 0.4 to 1.8 mmHg. Daily insulin doses also showed small average reductions across the empagliflozin groups compared to placebo. The reported data shows that rates of low blood sugar episodes (episodes with a confirmed very low blood glucose reading and/or severe symptoms) were recorded across all groups, with rates per patient per year ranging from approximately 5.77 to 8.33 events depending on the group and the time window measured — notably, these rates were not lower in the empagliflozin groups compared to placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01856595 · results posted 1 November 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01856595) tested an investigational medicine called PF-06291874 and involved 117 participants in total. The trial was split into two parts: Part A, which tested several different doses (5 mg, 15 mg, 50 mg, 100 mg, and 150 mg) compared to a placebo (a dummy treatment with no active ingredient), and Part B, which tested two doses (15 mg and 30 mg) again compared to a placebo. The trial measured a number of things related to how the body responded to the medicine, including episodes of low blood sugar (called hypoglycaemic events), heart rhythm readings (via ECG — a trace of the heart's electrical activity), and basic physical measurements like blood pressure and pulse rate. The reported data shows the following for low blood sugar episodes: in Part A, 2 participants in the placebo group, and between 1 and 2 participants in each of the active dose groups, experienced a low blood sugar event. In Part B, 7 participants in the placebo group, 4 in the 15 mg group, and 13 in the 30 mg group experienced such an event. For heart rhythm readings flagged as potentially concerning, the reported data shows zero participants in any group met those criteria in Part A, and in Part B, zero participants met criteria in most categories, with the exception of one specific heart rhythm measure where 1 participant in the placebo group, 1 in the 15 mg group, and 2 in the 30 mg group were flagged. For blood pressure and pulse readings of potential concern, only a small number of participants across both parts were flagged — mostly 0 or 1 per group — with the placebo group accounting for some of those instances. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02655666 · results posted 21 September 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 16 participants, all of whom used the Medtronic MiniMed Paradigm® REAL-Time System — a combined insulin pump and continuous glucose monitor. The trial ran for one year and was measuring changes in blood sugar control over that time. Notably, only 4 of the 16 participants completed the study, while 12 did not complete it; the data was not reported separately for those who finished versus those who did not. The reported data shows that the main thing being measured was a blood marker called HbA1c (glycosylated haemoglobin), which reflects average blood sugar levels over roughly three months — a higher number generally indicates higher average blood sugar. The reported change in HbA1c from the start to the end of the study was 0.9 percentage points. For the continuous glucose monitoring readings, the reported average glucose values across four different time periods during the study were 9.8, 10.4, 9.5, and 8.0 mmol/L respectively. The reported spread (variability) of glucose readings also changed across those periods, with the average spread starting at 3.5 mmol/L and reaching 2.0 mmol/L by the final period. The reported average number of low blood sugar episodes (readings at or below 3.9 mmol/L) per person across the four periods were 0.5, 0.3, 0.1, and 0.2 events respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01834144 · results posted 20 September 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled a very small number of participants — 1 person in the "Moderate Intensity Exercise" group and 3 people in the "Moderate + Vigorous Intensity Exercise" group, for a total of 4 participants. The trial was looking at what happens to blood sugar levels in the 12 hours after exercise in people using continuous glucose monitors, specifically measuring the amount of time blood sugar dropped below 4.0 mmol/L (a level considered low). A secondary measure looked at how much blood sugar levels fluctuated up and down after exercise. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for either the primary outcome (time spent with low blood sugar after exercise) or the secondary outcome (the degree of blood sugar fluctuation). The measurements fields for both outcomes are empty in the submitted data. This means the actual numbers from the study were not reported in the registry, so it is not possible to describe what the monitoring found. One participant in the combined exercise group also did not complete the trial, though the reason was not reported in the data. It is worth noting that with only 4 participants in total, this was an extremely small study — far smaller than most clinical trials — which the researchers would typically acknowledge as a significant limitation when interpreting any results. Because no outcome numbers were submitted, no conclusions about the measurements can be drawn from the registry entry alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02509065 · results posted 31 August 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02509065) enrolled 24 participants in total. It tested a "bionic pancreas" — an automated device that manages blood sugar levels — comparing different settings of the device against each other and against usual care (participants managing their own diabetes as they normally would). The device was tested in two versions: one that delivers only insulin ("insulin only"), and one that delivers both insulin and glucagon, a hormone that raises blood sugar ("bihormonal"). The trial looked at different target blood sugar set points ranging from 100 to 145 mg/dl (milligrams per decilitre, a measure of sugar in the blood). The main things being measured were average blood sugar levels, and the amount of time participants spent with dangerously low blood sugar (below 60 mg/dl). The reported data shows that average blood sugar levels (measured over two days by a continuous monitor worn on the body) varied across the different settings. Under usual care, the reported average was 158 mg/dl. Among the device settings, the reported averages ranged from 136 mg/dl (100 mg/dl set point, bihormonal) up to 174 mg/dl (145 mg/dl set point, insulin only). For time spent with very low blood sugar (below 60 mg/dl), usual care showed 1.38% of the time, while device settings ranged from about 0.4% (110 mg/dl bihormonal) to 1.34% (110 mg/dl insulin only). For an in-clinic exercise test, the reported data shows that 3 out of the participants in the 110 mg/dl insulin-only arm had two or more consecutive very low blood sugar readings (below 60 mg/dl), compared with 1 participant in the 110 mg/dl bihormonal arm, and 0 in either 130 mg/dl arm. Nausea, rated on a 0–10 scale, was reported as low across all groups, with scores ranging from 0.26 to 1.2 — all under the mild threshold of 3. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01755416 · results posted 21 August 2018

According to the results reported on ClinicalTrials.gov, this trial involved 18 people in total, split into two groups of 9. It used a "crossover" design, meaning each person tried both approaches at different times — one period using a closed-loop insulin delivery system on its own, and another period using the same system with the addition of a medicine called liraglutide. A closed-loop system is an automated way of delivering insulin that continuously monitors and adjusts blood sugar levels. The trial was measuring blood sugar levels under each of these two conditions. The reported data shows that during the period when participants used the closed-loop system with insulin alone, the average blood sugar level recorded was 159.7 mg/dL (milligrams per decilitre, a standard unit for measuring sugar in the blood). During the period when liraglutide was added to the closed-loop insulin system, the average blood sugar level recorded was 144.6 mg/dL. These are the only outcome figures reported in the submitted data. No secondary outcome measure results were included in the data provided, so those figures cannot be described here. It is also worth noting that not all participants completed both stages — a small number dropped out during the first intervention period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02688933 · results posted 20 August 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 638 people with diabetes — 320 assigned to an insulin called HOE901-U300 (also known as insulin glargine 300 units/mL) and 318 assigned to a comparator insulin called Lantus. The trial used a continuous glucose monitor (CGM) — a small device that checks blood sugar levels automatically every five minutes — to track how well each insulin kept blood sugar within a target range over roughly 16 weeks. The reported data shows that the main thing being measured was the proportion of time participants spent with their blood sugar in the range of 70–180 mg/dL (a commonly used target range). The HOE901-U300 group spent about 55.4% of the time in that range, while the Lantus group spent about 55.2% of the time there. For secondary measurements, the reported data shows that around 70.8% of HOE901-U300 participants and 68.3% of Lantus participants experienced documented symptomatic low blood sugar overnight (between midnight and 6 am) at some point during the study. The rate of those overnight low blood sugar episodes was reported as approximately 11.38 events per person-year for HOE901-U300 and 11.39 for Lantus. In the four hours before the next day's insulin injection, average blood sugar levels changed by about −2.0 mg/dL in the HOE901-U300 group and +5.7 mg/dL in the Lantus group from where they started. Other measures of blood sugar variability (how much levels fluctuated) were broadly similar between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02258373 · results posted 9 August 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 226 people in total — 149 in a group using a continuous glucose monitor (CGM) only, and 77 in a group using a CGM together with a traditional finger-prick blood glucose meter (BGM). Of those, 142 and 75 people respectively completed the study. The trial was primarily measuring how much time participants' blood sugar levels spent within a target range of 70 to 180 mg/dL (a common target range for people managing diabetes), as tracked by the CGM device. The reported data shows that, for the main outcome, the CGM-only group spent an average of 63% of the time with blood sugar in that target range, while the CGM+BGM group spent 65% of the time in range. For the secondary outcomes, the average blood sugar level was reported as 162 mg/dL in the CGM-only group and 158 mg/dL in the CGM+BGM group. A measure of how much blood sugar levels varied up and down (called the coefficient of variation — essentially how spread out the readings were) was 37% in both groups. The reported data also shows the percentage of time blood sugar readings fell below certain lower thresholds: below 70 mg/dL, the CGM-only group recorded 3.0% of the time and the CGM+BGM group 3.7%; below 60 mg/dL, it was 1.3% versus 1.6%; and below 50 mg/dL, it was 0.4% versus 0.5%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01781975 · results posted 8 August 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01781975) enrolled 67 people in total — 45 in the imatinib mesylate (a tablet medication) group and 22 in the placebo (inactive treatment) group. The trial was measuring whether imatinib mesylate had any effect on the insulin-producing cells in people with type 1 diabetes. The main thing being tracked was a substance called C-peptide, which is a marker of how much insulin the body is still producing on its own. Participants were followed for two years, with a key measurement taken at one year. The reported data shows that at the one-year mark, the average C-peptide level (measured during a standard meal test) was 0.834 nmol/L in the imatinib group and 0.775 nmol/L in the placebo group. At two years, the reported figures were 0.472 nmol/L for the imatinib group and 0.389 nmol/L for the placebo group. For a separate measure of blood sugar control called HbA1c (a percentage that reflects average blood sugar over several months), the reported data shows figures of 6.33% (imatinib) and 6.51% (placebo) at one year, and 6.44% (imatinib) and 7.03% (placebo) at two years. The reported insulin dose used per kilogram of body weight per day was 0.307 units/kg (imatinib) versus 0.413 units/kg (placebo) at one year, and 0.389 units/kg versus 0.488 units/kg at two years. The number of severe low blood sugar episodes reported was 2 in the imatinib group and 3 in the placebo group over the whole study. The reported data also shows that the total number of adverse events (any unwanted medical occurrences noted during the study) was 172 in the imatinib group and 28 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01421225 · results posted 7 August 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01421225) enrolled 10 people in total — 4 started in the "Standard Insulin Pump Therapy First" group and 6 started in the "Closed-Loop Insulin Therapy First" group. One participant in the second group did not complete the trial. The study used a crossover design, meaning participants tried both approaches at different times. The trial was measuring how well each approach kept blood sugar levels within a target overnight range (110–200 mg/dL, as defined by the American Diabetes Association for this age group), as well as blood sugar levels around mealtimes and how often low blood sugar episodes needed to be treated overnight. The reported data shows that for the primary outcome — the number of hours spent within the target overnight blood sugar range — participants using standard insulin pump therapy averaged 3.2 hours in range, while those using closed-loop insulin therapy averaged 5.3 hours in range, out of a 10-hour overnight window (10 PM to 8 AM). For the secondary outcomes, the reported data shows the peak blood sugar after breakfast was 353 mg/dL for the standard pump group and 367 mg/dL for the closed-loop group. The number of overnight low blood sugar episodes requiring treatment was 4 for the standard pump group and 5 for the closed-loop group. Blood sugar measured just before lunch was reported as 273 mg/dL for the standard pump group and 189 mg/dL for the closed-loop group. It is worth noting that this was a very small trial with only 10 participants, so these numbers reflect a limited snapshot of data. The reported figures describe what was measured in this specific group under these specific study conditions and should be understood in that context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02660242 · results posted 7 August 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 16 participants and used a crossover design — meaning each person tried all four approaches on separate occasions so they could be compared. The four approaches tested around exercise were: doing nothing extra (Control), reducing the background insulin dose before exercise (Basal Insulin Reduction), taking glucose tablets before exercise (Glucose Tabs), and receiving a small injection of glucagon using a device called the G-Pen Mini™ (Glucagon Injection). The trial was measuring how blood sugar levels behaved during exercise and in the hours that followed. The reported data shows that during exercise and the early recovery period, blood sugar levels (measured in mg/dL — a standard unit for blood sugar) were notably higher in the Glucose Tabs group (reported as 174 mg/dL, then 222 mg/dL at two time points) and the Glucagon Injection group (161 mg/dL, then 163 mg/dL), compared with the Control and Basal Insulin Reduction groups (both around 85–92 mg/dL across those same time points). For the secondary outcomes, the reported data shows that low blood sugar episodes (below 70 mg/dL, which is considered hypoglycaemia) during exercise and early recovery occurred in 6 participants in the Control group and 5 in the Basal Insulin Reduction group, but in 0 participants in either the Glucose Tabs or Glucagon Injection groups. High blood sugar episodes (at or above 250 mg/dL, known as hyperglycaemia) were reported in 5 participants in the Glucose Tabs group and 1 in the Glucagon Injection group, with none reported in the Control or Basal Insulin Reduction groups. The reported data for the later recovery period (tracked by a continuous glucose monitor worn on the body) shows that the lowest blood sugar readings reached were similar across all four groups (ranging from 44 to 51 mg/dL), as were the peak readings (239 to 269 mg/dL) and average readings (129 to 147 mg/dL). These figures suggest blood sugar continued to fluctuate during late recovery regardless of which approach was used, though the trial was not designed to draw firm conclusions from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02280863 · results posted 3 July 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02280863) tested an automated insulin delivery system — sometimes called a "closed-loop" or "artificial pancreas" system — in people with type 1 diabetes. The trial had two groups: an adult cohort and an adolescent cohort. Eight adults used an Android-based version of the system, nine adults used an integrated (all-in-one) version, and 15 adolescents used the integrated version. All eight adults in the Android group and all nine adults in the integrated group finished their phase of the trial; 14 out of 15 adolescents completed theirs. The primary outcome was a strict safety benchmark — it counted how many participants went through the trial without certain concerning blood sugar events (such as glucose dropping below 50 mg/dL, glucose staying above 300 mg/dL for more than an hour on more than two occasions, dangerous ketone levels, seizures, or loss of consciousness). The reported data shows that, of the three sub-groups, only 1 participant (in the adolescent cohort) met all of those criteria; none of the adult sub-groups reported any participants meeting the full set of criteria, though the data as reported does not explain why. For the secondary outcomes, the reported data shows average blood glucose levels (measured by a continuous sensor worn under the skin) ranged from around 142 to 171 mg/dL across the groups and time points. The proportion of time participants' glucose stayed within the target range of 70–180 mg/dL ranged from about 55% to 72% depending on the group and time point measured. Finger-prick readings below 70 mg/dL (a low blood sugar threshold) made up between roughly 1% and 14% of all finger-prick tests, varying by group and time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02555631 · results posted 28 June 2018

According to the results reported on ClinicalTrials.gov, 29 people took part in this trial, which looked at a lifestyle intervention program for men who had been identified as pre-diabetic. The program ran for 16 weeks, and the trial was measuring things like weight change, how many men could be recruited within 8 weeks, and how often participants attended sessions. Of the 29 who started, 25 completed the study, and 4 did not finish. The reported data shows that, on average, participants lost 3.8% of their starting body weight over the course of the program. The trial had set a goal of losing 5–7% of starting body weight, so the reported average fell below that target. For attendance, the reported data shows that participants attended an average of 11.7 out of 16 sessions. The trial had set a goal of attending at least 9 out of 16 sessions on average, and the reported figure was above that mark. The reported data also shows that 29 men were enrolled within the 8-week recruitment period, and 25 participants took part in each session on average by the end of the program. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00331162 · results posted 6 June 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 222 people who were receiving kidney or pancreas transplants. They were split into two groups: 113 people received a preparation medicine called Alemtuzumab before their transplant, and 109 people received a different preparation medicine called Anti-Thymocyte Globulin. The trial was measuring how many participants survived, whether their transplanted organ continued to function (called "graft survival"), how many experienced their body trying to reject the new organ (called "acute rejection"), and how many experienced certain unwanted events such as infections or other medical complications. The reported data shows that, out of 113 people in the Alemtuzumab group, 109 survived, compared with 104 out of 109 in the Anti-Thymocyte Globulin group. For transplanted organ survival, the reported numbers varied depending on the type of transplant — for kidney-alone transplants, 78 participants in the Alemtuzumab group and 84 in the Anti-Thymocyte Globulin group had the organ continue functioning; for combined pancreas-kidney transplants, the figures were 21 versus 13; and for pancreas-after-kidney transplants, 4 versus 0. The reported data shows that 16 people in the Alemtuzumab group experienced acute rejection compared with 28 in the Anti-Thymocyte Globulin group. For infectious events, the numbers reported for various infection types (including viral and bacterial) were broadly similar between groups, though some individual infection categories showed differences. For other reported complications such as certain cancers or lymph-related disorders, the numbers were very small (0–2 participants across both groups). The data for haematological (blood-related) unwanted events was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01464346 · results posted 30 May 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 90 people across three groups, depending on where a continuous glucose monitoring sensor (the Enlite sensor) was placed on their body — either the abdomen, the buttock, or both. The trial was measuring how accurately the sensor's glucose readings matched readings taken from blood samples analysed by a laboratory device (called a YSI analyser, which acts as the reference standard). The researchers looked at this accuracy under two different calibration schedules: once every 12 hours (the minimum), and 3–4 times per day. Almost all participants completed the trial — only one person did not finish. The reported data shows that when sensors were calibrated just once every 12 hours, across both body sites combined, an average of 88.01% of the sensor's readings fell within 30% of the reference blood sample reading. When sensors were calibrated more frequently — 3 to 4 times per day — that figure rose slightly to 90.52%. The trial also reported a separate measure called Mean Absolute Relative Difference (MARD), which is simply the average percentage gap between the sensor's reading and the reference reading — a smaller number means the readings were closer together. For the abdomen site with frequent calibration, the reported MARD was 13.6%, and with 12-hourly calibration it was 14.7%. For the buttock site, the reported MARD was 15.5% with frequent calibration and 18.2% with 12-hourly calibration. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02862730 · results posted 17 May 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02862730) enrolled 25 participants in total across seven groups, each of whom tried up to four different approaches to managing blood sugar levels using insulin pump technology. The four approaches being compared were: Sensor Augmented Pump therapy (SAP, a standard pump with a glucose sensor), Predictive Low Glucose Suspend (PLGS, a pump that can pause insulin delivery if low blood sugar is predicted), Single Hormone Closed-loop (SH, an automated system using insulin only), and Dual Hormone Closed-loop (DH, an automated system using both insulin and glucagon). Each participant wore a continuous glucose monitor (a small device that tracks blood sugar levels) and each approach was tested over an 84-hour (3.5-day) period, with rest periods in between. The trial was primarily measuring how much time participants' blood sugar spent below 3.9 mmol/L (a low blood sugar level) and how much time it stayed within the target range of 3.9–10 mmol/L, both across the full 84-hour period and in the four hours after exercise. The reported data shows the following results for time spent with blood sugar below 3.9 mmol/L across the full 84 hours: PLGS recorded 1.8% of the time, DH recorded 1.2%, SH recorded 2.7%, and SAP recorded 3.0%. In the four hours after exercise specifically, the reported figures were: PLGS 6.9%, DH 3.5%, SH 7.5%, and SAP 4.0%. For time spent in the target blood sugar range (3.9–10 mmol/L) over the full 84 hours, the reported data shows: PLGS 62.9%, DH 72.7%, SH 75.6%, and SAP 63.1%. In the four hours after exercise, the figures reported were: PLGS 78.0%, DH 84.6%, SH 84.4%, and SAP 79.4%. Among the secondary outcomes, the reported average blood sugar level (measured in mg/dL) was 165.9 for PLGS, 154.1 for DH, 146.8 for SH, and 161.9 for SAP. The reported number of times per day participants needed to treat low blood sugar with carbohydrates was 1.3 for PLGS, 0.8 for DH, 1.6 for SH, and 1.4 for SAP. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01454284 · results posted 17 April 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,114 people in total — 664 were assigned to receive an experimental insulin called LY2605541 combined with insulin lispro, and 450 received a standard insulin called insulin glargine also combined with insulin lispro. The trial was primarily measuring HbA1c — a blood test that gives an indication of a person's average blood sugar level over roughly two to three months. Around 548 people in the first group and 377 in the second group completed the study. The reported data shows that, at a key measurement point, the average HbA1c reading was 7.38% in the LY2605541 group and 7.61% in the insulin glargine group. At 52 weeks, the reported change from participants' starting HbA1c was a decrease of 0.46 percentage points in the LY2605541 group and a decrease of 0.24 percentage points in the insulin glargine group. For the secondary outcome looking at the proportion of participants reaching an HbA1c of 7.0% or below, the reported figures were approximately 45% in the LY2605541 group and 35% in the insulin glargine group at one time point. The reported data also shows that low blood sugar episodes (recorded when blood sugar dropped to a certain level or when symptoms were reported) were very common in both groups — occurring in approximately 99% of participants in each group across the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02702011 · results posted 2 April 2018

According to the results reported on ClinicalTrials.gov, this trial involved 48 people in total, split across four groups: 11 received a placebo (a dummy treatment with no active ingredient), 13 received a low dose of empagliflozin (2.5 mg), 12 received a medium dose (10 mg), and 12 received a high dose (25 mg). The trial was measuring how much glucose (sugar) participants passed out of their bodies in their urine over a 24-hour period after seven days of treatment. This measurement is known as urinary glucose excretion. Almost all participants completed the study — only one person in the 2.5 mg group did not finish. The reported data shows the change in the amount of sugar passed in urine over 24 hours, compared to each participant's starting level before treatment began. In the placebo group, the average change was a slight decrease of 0.46 grams per 24 hours — meaning their urinary sugar levels stayed roughly the same. In the empagliflozin groups, the reported average increases were: 64.63 grams per 24 hours in the 2.5 mg group, 80.73 grams per 24 hours in the 10 mg group, and 97.64 grams per 24 hours in the 25 mg group. No secondary outcome measure results were included in the data submitted to ClinicalTrials.gov, so those figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02268214 · results posted 29 March 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 833 people in total across three groups: 277 people took dapagliflozin 5 mg alongside insulin, 296 took dapagliflozin 10 mg alongside insulin, and 260 took a placebo (a dummy pill with no active ingredient) alongside insulin. The trial ran for 24 weeks and was primarily measuring changes in a blood marker called HbA1c — a measure of average blood sugar levels over roughly three months. It also tracked a number of secondary measurements, including daily insulin dose, body weight, and continuous glucose monitor readings (a device that tracks blood sugar levels throughout the day). The reported data shows that, at 24 weeks, the average HbA1c figure fell by 0.45 percentage points in the 5 mg dapagliflozin group and by 0.47 percentage points in the 10 mg dapagliflozin group, compared with a fall of just 0.03 percentage points in the placebo group. For the secondary measurements, the reported data shows the average daily insulin dose changed by −7.74 units in the 5 mg group and −12.16 units in the 10 mg group, while it rose by 1.16 units in the placebo group. Average body weight changed by −3.00 kg and −3.67 kg in the 5 mg and 10 mg groups respectively, compared with a very small increase of 0.05 kg in the placebo group. Continuous glucose monitor readings also showed reported differences between groups: average 24-hour glucose levels dropped by 10.28 and 12.97 mg/dL in the two dapagliflozin groups but rose by 5.06 mg/dL in the placebo group. The measure of how much glucose levels swung up and down during the day (called Mean Amplitude of Glucose Excursions) fell by 14.92 and 16.55 mg/dL in the dapagliflozin groups, while it rose by 2.38 mg/dL in the placebo group. Finally, the proportion of time blood sugar stayed within a commonly tracked range (between 70 and 180 mg/dL) increased by 6.98% and 8.52% in the two dapagliflozin groups, while it decreased by 2.13% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02637037 · results posted 13 March 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 80 healthy adult participants in total — 40 in Part 1 and 40 in Part 2. The trial was comparing two combination tablets (containing dapagliflozin and metformin, used together to manage type 2 diabetes) made at two different manufacturing sites: one in Mt. Vernon, USA, and one in Humacao, Puerto Rico. The goal was to test whether tablets from both factories behaved the same way in the body — this is called "bioequivalence" testing, meaning the study was checking whether the two versions of the tablet absorbed into the bloodstream in a similar way. Tests were done both when participants had fasted (not eaten) and after a meal. The reported data shows that 36 of 40 participants in Part 1 and 39 of 40 in Part 2 completed the trial. The reported data shows that the main measurements looked at how much of each active ingredient (dapagliflozin and metformin) entered the bloodstream and how quickly it peaked. For dapagliflozin, the total drug exposure in the blood (measured as area under the concentration–time curve, a way of tracking how much drug was in the body over time) ranged from roughly 236 to 517 units (h·ng/mL) across the different tablet doses and conditions tested. For metformin, those same exposure figures were in the range of approximately 4,398 to 5,484 units. The peak blood concentration of dapagliflozin ranged from about 40 to 133 ng/mL, and for metformin from about 503 to 574 ng/mL, depending on dose and whether participants had eaten. The secondary measurements showed that dapagliflozin tended to reach its peak level in the blood within 1 to 3 hours, while metformin took around 4 to 6 hours, and the time it took for drug levels to fall by half ranged from roughly 12 to 17 hours across all conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00884611 · results posted 28 February 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people, of whom 19 completed the study (one person was enrolled but did not receive treatment). The trial tested a "predictive suspend" system — a device that used a continuous glucose monitor (a sensor worn on the body that tracks blood sugar levels around the clock) combined with an algorithm to predict when blood sugar might drop too low overnight, and automatically paused insulin delivery to try to prevent that from happening. Three versions of the algorithm were tested, each with a different "look-ahead" time (70 minutes, 50 minutes, and 30 minutes ahead). Each participant's nights were split into "control nights" (no automatic suspension) and "intervention nights" (automatic suspension active), so the same group of people provided both sets of data. The reported data shows the main thing being measured was how often blood sugar dropped below 60 mg/dL overnight — a level considered undesirable. On control nights (no intervention), this happened on roughly 22–25% of nights depending on which algorithm version was being compared. On intervention nights, the reported figures were lower: 12% for the 70-minute algorithm, 11% for the 50-minute algorithm, and 8% for the 30-minute algorithm. A secondary measure looked at how often blood sugar went above 180 mg/dL overnight — also considered undesirable. The reported data shows this occurred more often on intervention nights than control nights across all three algorithms (for example, 78% versus 63% for the 70-minute version, and 60% versus 49% for the 30-minute version). The trial also measured morning blood sugar levels; the reported averages on intervention nights were higher than on control nights across all three algorithms, ranging from 144–158 mg/dL on intervention nights compared with 125–138 mg/dL on control nights. The study noted that a desirable morning blood sugar range was 70–180 mg/dL. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01301456 · results posted 9 February 2018

According to the results reported on ClinicalTrials.gov, this trial tested an investigational medicine called PF-04856883 and was run in two stages. In Stage 1, participants received a single dose at one of six different dose levels (4 mg, 8 mg, 12 mg, 18 mg, 24 mg, or 36 mg), or a placebo (a dummy treatment with no active ingredient). In Stage 2, participants received either a placebo or one of three different multi-dose schedules, where the dose was gradually increased over time. In total, 52 people took part across both stages. The trial was primarily measuring things like unwanted medical events, physical examination findings, heart tracing (ECG) changes, vital signs (such as blood pressure and pulse), and blood and urine test results. It also measured how much of the medicine appeared in participants' blood after dosing. The reported data shows that, for the primary outcomes, zero participants in any group experienced a treatment-emergent adverse event (an unexpected medical occurrence during or shortly after treatment) or a serious adverse event. Zero participants had clinically significant findings on physical examination across all groups. For heart tracings (ECGs), zero participants had concerning changes in Stage 1, while in Stage 2, one participant in the placebo group and one participant in one of the active dose groups had a potentially notable ECG finding. For vital signs and laboratory (blood and urine) tests, the numbers reported reflected the total number of participants in each group rather than the number with abnormalities — meaning the data as submitted does not allow a clear count of how many individuals had abnormal results for those two measures specifically. The reported data also shows that the peak level of PF-04856883 measured in participants' blood (called Cmax, or maximum concentration) increased as the dose went up in Stage 1: approximately 181 nanograms per millilitre at 4 mg, rising to around 2,006 nanograms per millilitre at 36 mg. No equivalent blood level figures were reported for Stage 2 in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01831765 · results posted 23 January 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01831765) enrolled 1,143 adults across three groups. One group received a faster-acting form of insulin aspart taken at mealtimes ("Faster Aspart Meal"), a second group received the same faster-acting insulin but taken after meals ("Faster Aspart Post"), and a third group received the existing insulin NovoRapid at mealtimes ("NovoRapid Meal"). The trial's main focus was on measuring HbA1c — a blood test that reflects average blood sugar levels over roughly three months — after 26 weeks of treatment. Around 1,030 to 1,050 participants completed the trial across the three groups. The reported data shows that for the primary measure, average HbA1c levels at the start of the trial were similar across all three groups (around 7.6%). After 26 weeks, the reported average HbA1c was 7.31% in the Faster Aspart Meal group, 7.51% in the Faster Aspart Post group, and 7.42% in the NovoRapid Meal group. For the secondary measure of blood sugar rise in the two hours after a meal, the starting values were also similar across groups (around 6.1–6.2 mmol/L), and after 26 weeks the reported figures were 5.88 mmol/L for Faster Aspart Meal, 6.73 mmol/L for Faster Aspart Post, and 6.55 mmol/L for NovoRapid Meal. The reported data also shows that average body weight changed only slightly across all three groups over 26 weeks (increases of less than 1 kg in each group). Low blood sugar episodes (hypoglycaemia) were recorded as a rate per 100 patient-years and were reported as approximately 5,899 for Faster Aspart Meal, 5,443 for Faster Aspart Post, and 5,865 for NovoRapid Meal. General adverse events (unwanted medical occurrences during the trial) were reported at rates of 445.8, 441, and 411 events per 100 patient-years for the three groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01787916 · results posted 5 January 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01787916) involved 15 people with type 1 diabetes who were overweight and using a basal/bolus insulin regimen (a type of insulin treatment involving background and mealtime doses). It used a "crossover" design, meaning all participants tried both liraglutide (a medication given by injection) and a placebo (an inactive substitute) at different times, with a short break in between. Eight people started with liraglutide first, and seven started with placebo first. All 15 participants completed every stage of the trial. The reported data shows that the trial's main measurement was HbA1c — a blood test that reflects average blood sugar levels over roughly three months, reported as a percentage. According to the results reported on ClinicalTrials.gov, the change in HbA1c over 24 weeks was reported as 0.3 percentage points in the liraglutide group and 0.2 percentage points in the placebo group. The trial also intended to measure changes in body fat (adipose tissue) as a secondary outcome, however no numerical data for that measurement was reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01113801 · results posted 13 December 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 417 people across four groups: one group received a placebo (a dummy treatment with no active ingredient), and the other three groups received different doses of an experimental drug called LY2382770 — either 2 mg, 10 mg, or 50 mg. The trial ran for 12 months and was primarily looking at changes in kidney function over time, measured through a blood marker called serum creatinine (a waste product the kidneys filter out — higher levels can suggest the kidneys are working less well). Around 62–66 people in each group completed the full study, with roughly 37–41 in each group not completing it. The reported data shows that for the primary measure — the change in serum creatinine levels from the start to the 12-month mark — all four groups showed a small increase over time. The placebo group's figure was 0.13 (on a mathematical scale used to analyse the data), while the three LY2382770 groups each recorded figures of 0.17–0.18. For the secondary measures, the reported data shows changes in a urine protein ratio (another marker linked to kidney health) were similarly small across all groups: 0.06 for placebo, 0.05 for the 2 mg and 10 mg groups, and −0.01 for the 50 mg group. The rate at which kidney filtration capacity (eGFR — a standard measure of how well kidneys filter the blood) changed per month was reported as −0.37 for placebo, −0.37 for the 2 mg group, −0.56 for the 10 mg group, and −0.40 for the 50 mg group. Drug exposure levels in the blood were also measured and increased with higher doses, though no placebo figure applies for that measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02105324 · results posted 20 October 2017

According to the results reported on ClinicalTrials.gov, this trial involved 19 people in total — 9 in one group and 10 in another. It used a "crossover" design, meaning everyone tried both approaches at different times: one period using a device called the "bionic pancreas" (an automated system that monitors and adjusts blood sugar levels automatically) and one period receiving their usual diabetes care. The trial was measuring blood sugar levels using a continuous glucose monitor (CGM), a small sensor that records a reading every five minutes. All 19 participants completed both periods of the trial with no drop-outs reported. The reported data shows that for the main outcomes (measured over days 2 to 5 of each period), the average blood sugar reading was 136.8 mg/dL during the bionic pancreas period compared to 167.4 mg/dL during usual care. The reported data also shows that participants spent an average of 1.2% of the time with their blood sugar below 60 mg/dL (a very low level) during the bionic pancreas period, compared to 2.8% of the time during usual care. For the secondary measures, the reported data shows that during days 2 to 5, participants spent about 80.6% of their time with blood sugar in the target range of 70–180 mg/dL with the bionic pancreas, compared to 57.6% with usual care. The proportion of time spent with blood sugar above 180 mg/dL was reported as 16.5% with the bionic pancreas and 36.3% with usual care. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00575159 · results posted 9 October 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 participants, and all 10 completed the study. The trial was examining a drug called GSK189075 (tested at three different doses: 50 mg, 150 mg, and 500 mg) and comparing it to two control groups — one receiving a placebo (a dummy treatment with no active ingredient) and one receiving a placebo plus a fast-acting insulin. Because each participant went through multiple treatment periods, the numbers reported for each group can exceed 10. The trial was primarily measuring things related to monitoring and tolerability, including any unwanted medical events (called adverse events), episodes of low blood sugar (hypoglycaemia), changes in blood pressure and heart rate, heart tracing (ECG) results, and blood test results. The reported data shows that the number of participants who experienced one or more adverse events ranged from 3 (in the placebo group) to 6 (in the 150 mg GSK189075 group), with no serious adverse events reported in any group. For low blood sugar episodes, the reported numbers ranged from 3 participants (in the 50 mg GSK189075 group) to 6 participants (in the 500 mg GSK189075 group), with 5 participants each in the placebo and placebo-plus-insulin groups. The reported data shows changes in blood pressure across groups ranged from small increases to small decreases (for example, systolic blood pressure changed by between −5.1 and +1.6 mmHg depending on the group), and heart rate changes ranged from approximately −5.4 to +1.7 beats per minute. Abnormal ECG findings were reported in 0 to 3 participants depending on the group, and abnormal blood chemistry results were reported in 4 to 8 participants across the various groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00678886 · results posted 3 October 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 272 participants in total across four groups: 10 adolescents who received a placebo, 19 adolescents who received the study drug otelixizumab, 81 adults who received a placebo, and 162 adults who received otelixizumab. All 29 adolescents completed the study, while 9 adults in each group (placebo and otelixizumab) did not complete it. The trial was measuring whether otelixizumab had any effect on insulin production and blood sugar control in people with type 1 diabetes, by tracking a protein called C-peptide (a marker of how much insulin the body is still making on its own), HbA1c levels (a measure of average blood sugar over roughly three months), and daily insulin use over 12 months. The reported data shows that for the primary outcome — the change in the body's own insulin production (measured via C-peptide) from the start of the trial to month 12 — both the placebo group and the otelixizumab group showed the same result: a decrease of 0.21 nanomoles per litre. For the secondary outcomes, the reported data shows that at the 12-month mark, 56 out of the otelixizumab participants met the combined target of good blood sugar control and low insulin use, compared with 34 in the placebo group. Average daily insulin use was reported as similar between groups at each time point (for example, at month 12: 0.39 units per kg per day for otelixizumab versus 0.42 for placebo). HbA1c levels at month 12 were also similar: 6.54% for otelixizumab and 6.45% for placebo. The reported data also shows counts of low blood sugar (hypoglycaemia) events across several categories. For example, the most common category — documented low blood sugar episodes — totalled 9,962 events in the otelixizumab group and 3,092 in the placebo group over the study period; however, the groups were of very different sizes, which the data as reported does not fully adjust for in this summary. The number of participants who experienced any documented low blood sugar was reported as 163 in the otelixizumab group and 78 in the placebo group. Severe hypoglycaemia (requiring help from another person) was reported in 4 otelixizumab participants and 2 placebo participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01123083 · results posted 15 September 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 179 people in total — 61 received a placebo and 118 received a drug called otelixizumab. Of those, 50 and 103 participants respectively completed the trial. The trial was looking at people with type 1 diabetes and was primarily measuring changes in the body's own insulin production over 12 months. Insulin production was tracked using a substance called C-peptide — a protein released alongside insulin — measured through a standardised meal test. The reported data shows that, for the main outcome at 12 months, C-peptide levels (a measure of the body's own insulin production) changed by −0.14 nanomoles per litre in the placebo group and −0.23 nanomoles per litre in the otelixizumab group — meaning both groups showed a decline from their starting levels, with the otelixizumab group showing a slightly larger decline. For secondary outcomes, the reported data shows that at various earlier time points (week 12 and month 6), both groups also generally showed changes in C-peptide levels, with figures shifting in different directions at different time points. A "responder" measure — defined as having a blood sugar control reading (HbA1c) at or below 6.5% and relatively low daily insulin use — was recorded in 19 placebo and 42 otelixizumab participants at one time point, 11 versus 26 at another, and 10 versus 23 at a third. Changes in daily insulin dose and HbA1c (a measure of average blood sugar over roughly three months) were also tracked across both groups, with small numerical differences reported at each time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00533442 · results posted 12 July 2017

According to the results reported on ClinicalTrials.gov, this trial involved 170 people who had received a simultaneous kidney and pancreas transplant — 86 were given a combination of tacrolimus, MMF (mycophenolate mofetil), and steroids, while 84 received tacrolimus, rapamycin, and steroids instead. The trial was measuring a range of outcomes over time, including how many participants experienced a tissue-confirmed rejection episode of either transplanted organ, how well each transplanted organ survived, and whether participants themselves survived. By the end of the follow-up period, 77 people in the first group and 74 in the second group completed the study. The reported data shows the following numbers of participants who experienced each tracked event. For kidney rejection confirmed by biopsy (a small tissue sample), 22 people in the MMF group and 8 in the rapamycin group had this occur. For pancreas rejection confirmed by biopsy, the numbers were 9 and 1 respectively. Kidney graft loss (not counting deaths as a cause) was reported in 18 people in the MMF group and 10 in the rapamycin group; pancreas graft loss on the same basis was 7 versus 2. When deaths were included in the count of graft loss, 26 people in the MMF group and 25 in the rapamycin group were affected. Patient deaths were reported as 16 in the MMF group and 15 in the rapamycin group. For the secondary measures, kidney function (estimated by a formula called eGFR, which reflects how well the kidneys filter the blood) was reported at 12, 36, and 60 months — the rapamycin group recorded 71.2, 63.0, and 56.5 units, while the MMF group recorded 67.2, 61.5, and 61.9 units. Pancreas function (measured by a hormone marker called C-peptide) across the same time points was reported as 1.15, 0.990, and 1.17 in the MMF group, and 1.08, 0.986, and 1.22 in the rapamycin group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00869414 · results posted 29 June 2017

The participant count data for this trial (NCT00869414) was not fully reported in the structured results submitted to ClinicalTrials.gov. The record lists three groups — people taking insulin glargine in the morning only, people taking it in the evening only, and people taking a split dose (part morning, part evening) — but the number of participants who started, completed, or did not complete the trial is recorded as zero across all groups. This may indicate the data was not properly entered rather than that no one participated. The trial was measuring two things: how much time per day participants spent with blood sugar levels that were too low (below 70 mg/dL, which is called hypoglycaemia), and how much that changed in the time they spent with blood sugar levels that were too high (above 180 mg/dL). According to the results reported on ClinicalTrials.gov, no numerical measurements were provided for either of the two primary outcome measures. The reported data shows empty results fields for both the low blood sugar time measure and the high blood sugar time measure across all three groups. Because no figures were submitted, it is not possible to describe what the trial found in terms of actual numbers. The reported data, in other words, does not include enough information to summarise any findings from this trial. If you are looking for results from this study, it may be worth checking whether they have been published elsewhere, such as in a medical journal, or speaking with a healthcare professional who may be aware of additional sources. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02402933 · results posted 26 June 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02402933) looked at a nasal glucagon spray (a dry-mist powder delivered into the nostril) as a way to treat low blood sugar episodes in children and teenagers with diabetes. Twenty-six participants were enrolled, 22 received at least one dose of the study drug, and 12 completed the trial. The main thing researchers were measuring was how many participants woke up or returned to a normal state within 30 minutes of receiving the nasal glucagon. The reported data shows that out of the participants who experienced a qualifying low blood sugar episode and received the nasal spray, 14 were recorded as awakening or returning to a normal status within that 30-minute window. For blood glucose (sugar) levels specifically, the reported data shows average increases from the starting level of roughly 58 mg/dL at 15 minutes, 107 mg/dL at 30 minutes, and 124 mg/dL at 45 minutes after the spray was given — meaning blood sugar levels appeared to rise over time after the dose, though what this means clinically is not for this summary to say. On the question of side effects picked up through a nasal symptom questionnaire (things like runny nose, sneezing, or watery eyes), the reported data shows that 100% of participants reported at least one of these nasal-related symptoms. Caregivers were also asked to rate how easy the device was to use and whether they preferred the nasal approach, using a scale from 1 to 7. The reported data shows a range of responses across those questions, but the full breakdown of scores for each individual question was not presented in a way that allows plain summarisation without risk of misrepresenting the figures. These numbers were reported but their meaning should be interpreted by a healthcare professional. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01222078 · results posted 16 June 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01222078) enrolled just one participant who received the study drug, otelixizumab. The trial was designed to measure safety-related information, including any unwanted medical events (called adverse events) and serious adverse events, as well as changes in vital signs such as blood pressure, heart rate, breathing rate, and body temperature. The study was ended early, and the single participant withdrew on day 164 of the study without completing it. The reported data shows that of the one participant who started the trial, one experienced at least one adverse event, and zero experienced a serious adverse event. For the vital signs measurements — including changes from the starting point in blood pressure, heart rate, breathing rate, and temperature — no numerical results were reported, meaning those figures are not available in the submitted data. Separately, the reported data shows that the one participant did have vital sign readings outside the normal range recorded on some occasions, though the participant did not receive the planned second course of treatment due to the early termination of the study. Because the trial was stopped early and involved only one person, the reported data is extremely limited. The reported outcome numbers cannot be used to draw any broad conclusions about the study drug. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01336023 · results posted 2 June 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,663 participants across three treatment groups: one group received a long-acting insulin called IDeg (414 people), one received a combination of that insulin with a separate medicine called liraglutide, referred to as IDegLira (834 people), and one received liraglutide alone (415 people). The trial ran for 52 weeks in total, with the main measurement taken at the 26-week mark. The key thing being measured was a blood sugar marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly three months — along with body weight, episodes of low blood sugar (hypoglycaemia), and other blood sugar-related measures. The reported data shows that, at 26 weeks, average HbA1c fell by 1.44 percentage points in the IDeg group, by 1.91 percentage points in the IDegLira group, and by 1.28 percentage points in the liraglutide-only group. For body weight, the IDeg group recorded an average increase of 1.6 kg, while the IDegLira group saw an average decrease of 0.5 kg, and the liraglutide-only group saw an average decrease of 3.0 kg. Low blood sugar episodes were recorded as events per 100 patient-years (a way of standardising counts across different amounts of time in the trial): IDeg had 256.7 events, IDegLira had 180.2 events, and liraglutide alone had 22.0 events. A measure of blood sugar rise after a meal also showed reductions across all three groups, with the IDegLira and liraglutide groups showing larger reductions than IDeg. The reported average daily insulin dose at week 26 was 53 units for IDeg and 38 units for IDegLira; this figure was not reported for the liraglutide-only group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02034513 · results posted 15 May 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 501 people in total (249 in one group and 252 in the other). It used a "crossover" design, meaning participants spent time on each of two long-acting insulins — insulin degludec (IDeg) and insulin glargine (IGlar) — so that both insulins were eventually compared within the same group of people. The trial was primarily measuring how often participants experienced low blood sugar episodes (hypoglycaemia) — specifically episodes that were either severe or confirmed by a blood glucose reading below a set threshold — during a 16-week "maintenance" phase of each treatment period. The reported data shows that during the maintenance periods, there were 2,772 such low blood sugar episodes recorded while participants were on insulin degludec, compared with 3,126 episodes on insulin glargine. For low blood sugar episodes occurring overnight (between 12:01 am and 5:59 am), the reported figures were 349 events on insulin degludec and 544 events on insulin glargine. When looking at severe episodes — those needing help from another person — the reported data shows 10.3% of participants experienced at least one such episode while on insulin degludec, compared with 17.1% while on insulin glargine. The number of adverse events (unwanted health events of any kind) reported was 925 on insulin degludec and 937 on insulin glargine. In terms of blood sugar control, a measure called HbA1c (a percentage that reflects average blood sugar over roughly three months) fell by 0.73 percentage points in the first treatment period for the IDeg-first group, and by 0.66 percentage points for the IGlar-first group; changes in the second period were smaller (0.04 and 0.17 percentage points respectively). Fasting blood glucose levels at the end of each period were also reported, ranging from approximately 7.45 to 8.62 mmol/L depending on the group and time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01991548 · results posted 15 May 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01991548) involved 40 people with insulin-dependent diabetes. One person did not complete the study, leaving 39 who finished. The trial was measuring how acceptable users found a particular insulin pump — the MiniMed 640G — and an associated device called the Guardian Link Transmitter, using questionnaires completed by participants. The reported data shows that acceptance was measured using a rating scale of 1 to 7 (sometimes called a Likert scale), where a score of 4 or above was considered a positive response. The overall average score reported for user acceptance was 6.02 out of 7. No other outcome measures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02463097 · results posted 18 April 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02463097) enrolled 124 participants, all placed in a single study arm. Of those, 123 completed the trial and 1 did not. The trial was looking at a measure called A1C — a blood test that gives an indication of average blood sugar levels over roughly three months — as well as tracking two types of serious events: severe low blood sugar episodes (severe hypoglycaemia) and a serious complication called diabetic ketoacidosis (DKA), where the blood becomes dangerously acidic. The reported data shows that, on average, participants' A1C levels changed by −0.5 percentage points over the course of the study, meaning the average recorded A1C was 0.5 percentage points lower at the end than at the start. It is worth noting that the trial was not designed to statistically test whether this change was meaningful — the researchers described it as a descriptive finding only, intended to observe and record what occurred rather than prove a cause-and-effect relationship. For the two serious event measures, the reported data shows that zero severe hypoglycaemia events and zero diabetic ketoacidosis events were recorded across the group during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02232698 · results posted 10 April 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 241 people — 120 in the group using a sensor-based continuous glucose monitoring system, and 121 in the group using standard finger-prick blood glucose testing. By the end of the study, 110 people in the sensor group and 101 in the standard testing group had completed it. The trial was looking at how much time participants spent with low blood sugar (below certain thresholds), high blood sugar, and within a healthy range, as well as a longer-term blood sugar marker called HbA1c (a blood test that reflects average blood sugar levels over roughly three months). Measurements were compared near the end of the study period (around days 194–208) against a baseline recorded at the start (days 1–15). The reported data shows the following numbers for the primary outcome — time spent with blood sugar below 70 mg/dL (a low blood sugar level): at baseline, the sensor group averaged 3.38 hours per day and the standard testing group averaged 3.44 hours per day; by the end of the study, those figures were reported as 2.03 hours per day and 3.27 hours per day respectively. For the secondary outcomes, time spent at even lower blood sugar levels (below 55 mg/dL) was reported as 0.80 hours/day (sensor group) versus 1.65 hours/day (standard group) at the study's end, compared to 1.59 and 1.77 hours/day at baseline. At the lowest threshold (below 40 mg/dL), the end-of-study figures were 0.26 versus 0.73 hours/day. For high blood sugar (above 180 mg/dL), the reported end-of-study values were 6.16 versus 6.08 hours/day, and above 240 mg/dL, 1.67 versus 2.06 hours/day. Time spent in the target range of 70–180 mg/dL was reported as 15.8 hours/day (sensor group) versus 14.6 hours/day (standard group) at the end of the study. The HbA1c secondary outcome showed very similar figures between groups — 6.94% for the sensor group and 6.95% for the standard group at six months, compared to 6.79% and 6.78% at baseline. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02059174 · results posted 8 March 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02059174) enrolled 76 people in total across two groups, who each received both MK-1293 (an investigational insulin) and EU-Lantus™ (a reference insulin product already approved in Europe) in an alternating sequence across four study periods. The trial was measuring how similarly the two insulins behaved in the body — specifically how long they acted, how much glucose needed to be given to keep blood sugar steady after an injection (a standard laboratory method called a "euglycemic clamp"), and how much of an active breakdown product of the insulin appeared in the blood. Most participants completed all four periods, with a small number not finishing each stage. The reported data shows that for the measure of how long each insulin continued to act, both MK-1293 and EU-Lantus™ reached the maximum clamp duration of 30 hours in the reported results. For the amount of glucose that needed to be given to keep blood sugar stable over the first 24 hours after injection, the reported figures were 1,470 mg/kg for MK-1293 and 1,555 mg/kg for EU-Lantus™. Over just the first 12 hours, the figures were 659 mg/kg and 736 mg/kg respectively, and over hours 12 to 24 they were 811 mg/kg and 818 mg/kg. The highest rate at which glucose needed to be given was reported as 2.34 mg/kg/min for MK-1293 and 2.43 mg/kg/min for EU-Lantus™. For the blood level of the active insulin breakdown product over 24 hours, the reported values were 6,530 pg·hr/mL for MK-1293 and 6,763 pg·hr/mL for EU-Lantus™. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01836523 · results posted 6 March 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01836523) enrolled 1,398 adults across four groups: three groups received different daily doses of a medicine called liraglutide (0.6 mg, 1.2 mg, or 1.8 mg), while a fourth group received a placebo (an inactive dummy treatment). All participants were also using insulin. The trial ran for 52 weeks and was measuring three main things: changes in blood sugar control (using a measure called HbA1c — a percentage that reflects average blood sugar levels over roughly three months), changes in body weight, and changes in the total daily dose of insulin participants needed. The reported data shows the following changes after 52 weeks compared to the start of the trial. For blood sugar (HbA1c), all four groups showed a decrease: the 0.6 mg liraglutide group fell by 0.45 percentage points, the 1.2 mg group by 0.50 points, the 1.8 mg group by 0.54 points, and the placebo group by 0.34 points. For body weight, the liraglutide groups saw reductions of 1.34 kg, 2.73 kg, and 4.02 kg respectively, while the placebo group's average weight increased by 0.94 kg. For insulin dose, the results were expressed as a ratio of the week-52 dose compared to the starting dose — a ratio of 1.0 would mean no change. The reported ratios were 1.04 for the 0.6 mg group (a slight increase), 0.98 for the 1.2 mg group, 0.95 for the 1.8 mg group, and 1.04 for the placebo group. The reported data also shows that the total number of low blood sugar episodes (where blood sugar dropped to a potentially concerning level or the person needed help from someone else) recorded across the study were 4,954 in the 0.6 mg group, 4,602 in the 1.2 mg group, 4,614 in the 1.8 mg group, and 3,654 in the placebo group. It is worth noting that not all participants completed the trial — dropout numbers ranged from 51 to 91 people across the four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02530450 · results posted 23 January 2017

According to the results reported on ClinicalTrials.gov, this trial involved 30 participants in total — 16 in Group 1 and 14 in Group 2. The trial was measuring changes in a blood marker called HbA1c (a measure of average blood sugar levels over roughly three months), as well as how much time participants spent with blood sugar levels that were too low (hypoglycaemia), too high (hyperglycaemia), or within a normal range (euglycaemia). Of the 30 who started, 19 completed the study — 10 from Group 1 and 9 from Group 2. The reported data shows that for the primary outcome — change in HbA1c — both groups recorded reductions across the measurements taken. For Group 1, the reported changes in HbA1c were −0.95%, −0.6%, and −1.1% at different time points or sub-measures. For Group 2, the corresponding reported figures were −0.9%, −0.9%, and −0.5%. These numbers represent how much the HbA1c reading changed (with a minus sign indicating a decrease) compared to where participants started. For the secondary outcome — the percentage of time participants spent with blood sugar that was too low, too high, or in the normal range — the reported data shows no measurements were submitted to ClinicalTrials.gov, so those results are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02181127 · results posted 26 December 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 22 participants, all of whom completed the study. The trial was testing a device called a "glucagon-only bionic pancreas" — an automated system that delivers the hormone glucagon to raise blood sugar when it drops too low — and comparing it to a placebo (an inactive version of the device). The main thing being measured was how much time participants spent with dangerously low blood sugar levels (below 60 mg/dl), captured using a continuous glucose monitor (CGM), a small sensor that tracks blood sugar throughout the day and night. The reported data shows that for the primary outcome — a combined measure of how far below 60 mg/dl blood sugar dropped and for how long — the glucagon device group recorded a score of 1,015 mg/dl/min, compared to 4,375.68 mg/dl/min in the placebo group (a higher score means more time spent at very low levels). For the secondary outcomes, the reported data shows the glucagon device group spent around 3.1% of the overall time with blood sugar below 70 mg/dl, compared to 8.7% for the placebo group. The average number of low blood sugar episodes recorded below 50 mg/dl was 1.73 for the device group versus 5.0 for the placebo group; below 60 mg/dl it was 4.14 versus 8.86; and below 70 mg/dl it was 8.95 versus 12.68. Regarding time spent in other blood sugar ranges, the device group spent about 68.9% of the time between 70–180 mg/dl compared to 61.9% for the placebo group. Overnight and daytime breakdowns for time below 70 mg/dl were reported for the device group only, at 3.92%, 1.50%, 7.94%, and 10.25% respectively; corresponding placebo figures were not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00905255 · results posted 21 December 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 69 people with type 2 diabetes across two groups: 33 participants received lixisenatide using a "two-step" dose increase approach, and 36 received it using a "one-step" dose increase approach. The trial ran for up to 76 weeks and was measuring changes in blood sugar control — mainly through a measure called HbA1c, which reflects average blood sugar levels over roughly three months — as well as tracking unwanted events that occurred during the study. The reported data shows that, looking at all 69 participants combined, average HbA1c levels were reported to have changed by minus 0.83 percentage points at week 52, and minus 0.72 percentage points at week 76. At week 52, around 40% of participants had an HbA1c reading below 7%, dropping to about 27% at week 76. Roughly 15% were below 6.5% at week 52, and about 18% at week 76. Approximately 17% of participants needed additional ("rescue") medication at some point during the first 24 weeks, rising to around 23% over the full study period. Regarding low blood sugar episodes (hypoglycaemia — when blood sugar drops to a potentially concerning level), the reported data shows 2 participants in the two-step group and 1 in the one-step group experienced a symptomatic episode; no severe episodes were recorded in either group. The reported data also shows that, across all participants combined, 91.3% experienced at least one treatment-emergent side event during the study, 4.3% had a serious unwanted event, no deaths were reported as related to the treatment, and 14.5% stopped the treatment permanently due to an unwanted event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02430870 · results posted 31 August 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT02430870) tested a drug called TAK-648 and ran in two separate parts. Part 1 included 16 people in total — six received a 0.35 mg dose, six received a 0.80 mg dose, and four received a placebo (a dummy treatment with no active ingredient). Part 2 included 32 people — groups of six received doses of 0.05 mg, 0.15 mg, 0.35 mg, or 0.80 mg, while eight received a placebo. The trial was primarily measuring how often participants experienced any unexpected medical event after taking the study drug, as well as whether their laboratory test results or vital signs (such as blood pressure, pulse, temperature, and breathing rate) showed notable changes. The reported data shows that in Part 1, 83.3% of participants in the 0.35 mg group and 33.3% in the 0.80 mg group experienced at least one unexpected medical event after receiving the study drug, compared with 100% of those in the Part 1 placebo group. In Part 2, the reported figures were 100% in the 0.05 mg group, 33.3% in the 0.15 mg group, 66.7% in the 0.35 mg group, and 83.3% in the 0.80 mg group, compared with 37.5% in the Part 2 placebo group. The reported data shows that no participants in any group — whether receiving TAK-648 or placebo — had notably abnormal laboratory test results at any point during the study. For vital signs, some participants across most groups, including the placebo groups, were reported to have at least one notably unusual reading at some point during dosing, though the specific figures varied across groups and measurement types. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00279305 · results posted 18 August 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT00279305) enrolled 87 people in total — 57 in the rituximab treatment group and 30 in the placebo group. The trial was measuring a substance in the blood called C-peptide, which is a marker of how much insulin the body is still producing on its own. To measure this, participants drank a special meal-like liquid and had their blood tested at set time points over two hours. The main goal was to compare C-peptide levels between the two groups at the one-year mark. The reported data shows that at the one-year point, the average C-peptide level (expressed as a weighted average across the timed blood samples) was 0.58 pmol/mL in the rituximab group and 0.429 pmol/mL in the placebo group. Of the 57 people who started in the rituximab group, 49 completed the study, while 29 out of 30 completed it in the placebo group. No secondary outcome measure data was included in the results submitted to ClinicalTrials.gov, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00100178 · results posted 16 August 2016

According to the results reported on ClinicalTrials.gov, this trial involved 114 participants split across three groups: one group received a combination of two medicines (MMF and DZB), one received MMF on its own, and one received a placebo (a dummy treatment with no active medicine). The trial was measuring something called "stimulated C-peptide," which is a substance in the blood that reflects how much insulin the body is still producing on its own. To measure this, participants consumed a mixed meal and had blood samples taken over two hours at set time points. The reported data shows the average level of stimulated C-peptide — expressed as an "area under the curve," which is a way of summarising the total amount measured across all the time points — was 0.28 pmol/ml for the MMF and DZB combination group, 0.27 pmol/ml for the placebo group, and 0.25 pmol/ml for the MMF-alone group. Of the 114 people who started the trial, 85 completed it (32 in the combination group, 32 in the placebo group, and 21 in the MMF-alone group). No secondary outcome data appears to have been reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01853072 · results posted 3 August 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 615 people in total — 308 in the nepafenac (eye drop) group and 307 in the vehicle (comparison drop, containing no active ingredient) group. The trial was looking at two main things after cataract surgery: whether participants' vision improved by a meaningful amount (gaining 15 or more letters on a standard eye chart, from before surgery through to day 90), and whether participants developed a swelling at the back of the eye called macular oedema (a build-up of fluid in a part of the retina important for sharp vision) within 90 days of surgery. The reported data shows that for the first primary measure — sustained vision improvement of 15 or more letters from before surgery through to day 90 — 61.7% of participants in the nepafenac group and 43.0% in the vehicle group met this threshold. For the second primary measure — development of macular oedema within 90 days — 2.3% of the nepafenac group and 17.3% of the vehicle group were recorded as developing this condition. For the secondary measures, the reported data shows that at day 60, 76.2% (nepafenac) versus 64.7% (vehicle) had gained 15 or more letters, and at day 90 those figures were 77.2% versus 67.7%. The proportion of participants who lost more than 5 letters of vision from day 7 onward was reported as 15.4% (nepafenac) versus 27.3% (vehicle), and those losing more than 10 letters was 9.1% versus 15.3%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02081001 · results posted 1 August 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 19 participants in total, spread across 12 subgroups that differed in the order they received doses and which of two glucagon products they received first. The two products being compared were "G-Pump" (a liquid glucagon formulation designed for use in a pump) and "GlucaGen" (a standard glucagon preparation). Each participant received three different dose levels — 0.3, 1.2, and 2.0 micrograms per kilogram of body weight — of both products. The trial was mainly measuring how quickly each product was absorbed into the bloodstream and how quickly blood sugar levels began to rise after each dose. All but one participant completed the trial. The reported data shows that, for the primary measures, G-Pump took longer than GlucaGen to reach half its peak blood level at the lowest dose (12.2 minutes versus 7.6 minutes), though the two products were closer together at higher doses (around 12–14 minutes for G-Pump versus 10–11 minutes for GlucaGen). Similarly, the time for blood sugar to reach half its peak level was reported as longer with G-Pump at the lowest dose (17.2 minutes) compared with GlucaGen (7.6 minutes), with the gap narrowing at higher doses. For the secondary measures, the reported peak glucagon blood levels rose with higher doses for both products, ranging from around 140–169 pg/dL at the lowest dose up to roughly 441–447 pg/dL at the highest dose. Peak blood sugar levels also rose with higher doses, ranging from approximately 162–178 mg/dL at the lowest dose to around 201–213 mg/dL at the highest dose. The time to reach peak glucagon levels was reported as 23–32 minutes depending on the product and dose, while the time to reach peak blood sugar ranged from approximately 26 to 53 minutes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00133809 · results posted 1 June 2016

According to the results reported on ClinicalTrials.gov, eight people took part in this trial, all in a single group that received an islet cell transplant (a procedure where insulin-producing cells are transplanted into a person). All eight participants completed the study. The trial was looking at whether people could stop using insulin injections after receiving the transplant, and also tracked their blood sugar control and signs that their body was producing its own insulin over a period of up to five years. The reported data shows that at the one-year mark — the main thing the trial was set up to measure — 5 out of 8 participants were no longer using insulin injections. The reported data also shows how participants tracked over time across several check-in points (at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after the transplant). The number not using insulin started at 6 participants at the earliest check-ins and gradually decreased to 2 participants by the four- and five-year marks. A separate blood sugar measure called HbA1c — a test that reflects average blood sugar levels over a few months — was at or below a level of 6.5% (considered a target for good blood sugar control) in 6 to 8 participants across the earlier time points, dropping to 4 participants by five years. A marker called C-peptide, which indicates whether the body is producing its own insulin, remained at or above a target level in 5 to 6 participants through the first two years, falling to 3 participants at the five-year point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01898286 · results posted 26 May 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01898286) enrolled 38 participants who had previously taken part in an earlier related study. All participants received a treatment called DiaPep. Thirty-five people completed the trial, while three did not finish. The trial was measuring things like low blood sugar episodes, a marker of insulin-producing cell activity (called C-peptide), daily insulin use, and blood sugar control over time. The reported data shows that, on average, participants recorded 3.3 low blood sugar (hypoglycaemic) events each over the course of the study. When looking at insulin-producing cell activity — measured using a test that checks how much of a substance called C-peptide is released in response to a hormone called glucagon — the reported average change from the starting point was 0.2 nmol\*minute/L. For daily insulin use (adjusted for body weight), the reported average change from the starting point was 0.025 IU/kg. The reported data also shows an average change of 0.46 percentage points in HbA1c — a measure of average blood sugar levels over roughly three months — from the starting point to the end of the study. It is worth noting that these figures represent changes observed during the trial period, not comparisons against a separate control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01726621 · results posted 18 April 2016

According to the results reported on ClinicalTrials.gov, this trial involved 55 adults with insulin-dependent diabetes. Four participants did not complete the study, leaving 51 who finished. The trial was measuring how acceptable users found two insulin pump models — the MiniMed 620G and 640G — along with a device called the Guardian Link Transmitter (a sensor that communicates with the pump). Participants were asked to rate their experience using a questionnaire. The reported data shows that acceptance was measured using a rating scale from 1 to 7, sometimes called a Likert scale, where a score of 4 or above was set as the threshold for a positive response. According to the results reported on ClinicalTrials.gov, the average score recorded across participants was 5.88 out of 7. No additional breakdown of individual questionnaire responses or secondary outcome data appears to have been reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02206607 · results posted 4 March 2016

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called PF-04937319, testing four different formulations of it — one immediate-release version (where the drug is released quickly) and three modified-release versions (where the drug is released more slowly over time). A total of 42 people started the trial in an initial run-in phase using metformin, and 39 of those went on to the main comparison phase. In that phase, 39 participants were spread across four groups, each trying all four formulations of PF-04937319 in a different order, with washout breaks in between. The trial was measuring how the drug moved through the body (absorption into the bloodstream) and how blood glucose levels changed over a day. The reported data shows that for the main measure of how much drug was absorbed over time (called AUCinf — essentially the total amount of drug detected in the blood), the immediate-release formulation (150+100 mg) recorded 10,690 ng·hr/mL, while the three modified-release formulations recorded lower figures: 3,187, 2,725, and 3,430 ng·hr/mL respectively. For blood glucose levels averaged across a full day, the reported figures were 159.47 mg/dL for the immediate-release group and 176.24, 170.85, and 180.47 mg/dL for the three modified-release groups. The reported data also shows the change from a reference point in daily glucose for the modified-release groups was 15.55, 15.96, and 20.15 mg/dL; this figure was listed as not available for the immediate-release group. The reported data shows that for secondary measures — the peak level of drug detected in the blood — the immediate-release formulation reached 641.2 ng/mL, compared with 161.8, 171.3, and 236.2 ng/mL for the three modified-release versions. Drug levels measured at 5, 16, and 24 hours after the morning dose were also reported, with the immediate-release formulation generally showing higher concentrations at each time point than the modified-release formulations across the board. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00116207 · results posted 5 January 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 44 people in total — 22 in an oral antioxidant group and 22 in a placebo (dummy treatment) group. The trial was looking at whether an oral antioxidant supplement affected nerve function in the heart in people with a condition called Cardiac Autonomic Neuropathy (a type of nerve damage affecting the heart). It ran for 24 months and used specialised medical imaging (PET scans) to track changes. Not everyone finished the study — 13 out of 22 completed it in the antioxidant group, compared with 18 out of 22 in the placebo group. The reported data shows that the main thing being measured was a score called the "retention index" — a number that reflects how well certain nerves in the heart are taking up a tracer used during the scan (higher generally means more nerve activity in that area). At the start of the study, the antioxidant group had a score of 0.081 and the placebo group had 0.073. At 24 months, the reported data shows the antioxidant group's score had changed to 0.070, while the placebo group's score was 0.074. For the secondary measures, the reported data shows coronary flow reserve (a measure of blood flow in the heart's arteries) was 2.95 vs 2.94 at the start and 3.02 vs 3.22 at 24 months for antioxidant and placebo groups respectively. A marker of oxidative stress (a type of chemical damage in the body) was reported as 2.92 for the antioxidant group and 2.09 for the placebo group, though it is not clear from the data at which time point this was measured. An inflammation marker (CRP) was reported as 17.51 for the antioxidant group and 16.95 for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02074384 · results posted 1 January 2016

According to the results reported on ClinicalTrials.gov, this trial involved 161 people in total, split across three groups: 74 people who used Continuous Glucose Monitoring (CGM, a sensor worn on the body that tracks blood sugar levels continuously), 70 people who used Self Monitoring Blood Glucose (SMBG, the traditional finger-prick method), and 17 clinicians (health professionals). All participants who started the trial completed it — none dropped out. The trial was measuring whether participants found more usefulness in a type of glucose data report called an Ambulatory Glucose Profile (AGP) compared to the standard way glucose data is usually displayed. The reported data shows that, out of the 74 people in the CGM group, 35 reported greater usefulness from the AGP report compared to the traditional glucose data report. In the SMBG group, 29 out of 70 people reported the same preference for the AGP report. Among the 17 clinicians, 10 reported finding greater usefulness in the AGP report. No other outcome measures were included in the submitted results data beyond this primary measure. It is worth noting that the reported data only tells us how many people in each group said they preferred the AGP format — it does not tell us about health outcomes or how either monitoring method affected participants' wellbeing. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01079234 · results posted 31 December 2015

According to the results reported on ClinicalTrials.gov, this trial involved people with diabetes who were testing different types of long-acting insulin. The main phase of the trial (the first 26 weeks) included 164 people in the "IDeg OD FF" group, 165 in the "IDeg OD" group, and 164 in the "IGlar OD" group. After the main phase, a 26-week extension ran from weeks 27 to 52, involving 133 people continuing in the IGlar OD group and 239 people in a combined group called "IDeg OD F." The trial was primarily measuring changes in a blood marker called HbA1c — a way of tracking average blood sugar levels over roughly three months — as well as episodes of hypoglycaemia (low blood sugar). The reported data shows that after 26 weeks, average HbA1c levels changed by −0.40 percentage points in the IDeg OD FF group, −0.41 in the IDeg OD group, and −0.58 in the IGlar OD group (all reductions from where people started). Fasting plasma glucose — a measure of blood sugar after not eating — changed by −1.28, −2.54, and −1.33 mmol/L respectively across those same three groups. After 52 weeks in the extension phase, the reported HbA1c change from the original starting point was −0.21 percentage points for IGlar OD and −0.13 for IDeg OD F, and fasting plasma glucose changed by −0.61 and −1.73 mmol/L respectively. For low blood sugar episodes during the extension, the reported data shows an overall rate of 6,341 episodes per 100 patient-years for IGlar OD and 6,811 for IDeg OD F. For episodes occurring overnight specifically, the reported rates were 848 per 100 patient-years for IGlar OD and 640 for IDeg OD F. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00982228 · results posted 29 December 2015

According to the results reported on ClinicalTrials.gov, this trial involved people with diabetes who were assigned to receive one of two types of long-acting insulin: insulin degludec (IDeg, given once daily) or insulin glargine (IGlar, given once daily). A total of 472 people started in the IDeg group and 157 in the IGlar group during the main 52-week period. The trial then continued into a 104-week extension phase, with 351 and 118 participants respectively carrying on into that stage. The trial was measuring several things, including changes in a blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over roughly three months), the rate of low blood sugar episodes (hypoglycaemia), the rate of unwanted health events (adverse events), and levels of antibodies to insulin in the blood. The reported data shows that after 52 weeks, both groups had a small reduction in their HbA1c — the IDeg group's average fell by 0.40 percentage points and the IGlar group's by 0.39 percentage points from where they started. After 104 weeks, the reported reductions were 0.27 percentage points for IDeg and 0.24 percentage points for IGlar. For confirmed low blood sugar episodes over the extension period, the reported rate was approximately 3,750 episodes per 100 patient-years in the IDeg group and 3,743 in the IGlar group. When looking only at low blood sugar episodes that occurred overnight (between midnight and 5:59 am), the reported rates were 390 per 100 patient-years for IDeg and 532 for IGlar. For general adverse events (any unwanted health event during the study), the reported rates were 383 per 100 patient-years for IDeg and 374 for IGlar. Antibody levels to human insulin were reported as broadly similar between groups (11.3% for IDeg and 11.0% for IGlar). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01957930 · results posted 21 December 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01957930) involved 91 people in total: 35 in an "intensified insulin treatment" group, 37 in a "standard treatment" group, and 19 healthy controls. All 91 participants who started the trial completed it, with no drop-outs recorded. The trial was looking at a specific foot complication — ischemic foot ulcers (a type of wound caused by reduced blood flow) — and whether the rate of hospital admissions for this condition differed between the two treatment groups. The reported data shows that, among those in the intensified insulin treatment group, 3 out of 35 participants were hospitalised for an ischemic foot ulcer during the study period. In the standard treatment group, 10 out of 37 participants were hospitalised for the same reason. These are simply the raw counts as submitted to ClinicalTrials.gov; no further statistical detail about what this difference means was included in the submitted results data. The trial also intended to measure microvascular endothelial function (how well the tiny blood vessels in the skin respond to certain stimuli), but no numerical results for this measure were included in the data submitted to ClinicalTrials.gov, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02138006 · results posted 21 December 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 102 people in total — 48 in an "intensive insulin treatment" group and 54 in a "standard insulin treatment" group. All participants completed the study, with no drop-outs recorded in either group. The trial was measuring outcomes related to serious heart and blood vessel complications, including deaths and illness linked to heart attacks, strokes, and kidney failure, in people receiving different levels of insulin treatment. The reported data shows that for the primary outcome — which tracked deaths from any cause as well as a combined count of deaths linked to heart attack, stroke, and kidney failure — 7 participants in the intensive insulin group and 11 participants in the standard insulin group had one of these events recorded. For the secondary outcome, which looked at the number of people who experienced (but did not necessarily die from) coronary heart disease, stroke, or kidney failure, the reported data shows 6 participants in the intensive insulin group and 11 participants in the standard insulin group. No further breakdown of these numbers, such as how they compare statistically, was included in the data submitted to ClinicalTrials.gov. It is worth noting that this was a relatively small trial, and the results are simply a count of how many people in each group experienced the events being tracked. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01449747 · results posted 14 December 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people with type 2 diabetes, split into two groups of 12: those who responded to a diabetes medication called sitagliptin (a tablet that works by blocking an enzyme in the body), and those who did not respond to it. All 24 participants completed the study. The trial was measuring levels of certain gut hormones — called GLP-1 (in both its "active" and "total" forms) and GIP — in the blood before and after taking a single 100 mg dose of sitagliptin, using a standard meal test. It also measured the activity of the enzyme that sitagliptin targets, known as DPP-4, to see whether differences in that enzyme's behaviour might explain why some people respond to the medication and others do not. The reported data shows that, before sitagliptin was taken, hormone levels at the start of the meal test were broadly similar between the two groups. After sitagliptin was taken, both groups showed changes in their hormone levels across the meal test time points. For active GLP-1, the responder group showed higher peak levels mid-meal (up to around 14.1 pmol/L) compared to the non-responder group at the same time points. For total GLP-1 and total GIP, the non-responder group tended to show higher readings at several time points than the responder group. When the overall hormone exposure across the whole meal test was summarised (using a measure called "area under the curve," which represents the total amount of hormone in the blood over time), the non-responder group generally had higher overall figures than the responder group across all three hormones. The reported data also shows that the DPP-4 enzyme activity — expressed as a percentage of each person's starting level — dropped in both groups after sitagliptin was taken, but the drop appeared larger in the responder group. For example, at 60 minutes into the meal test, responders showed enzyme activity at around 33.5% of their baseline, while non-responders were at around 59.6%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01019486 · results posted 14 December 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people across three groups: 5 non-diabetic participants (used as a comparison group), 5 people with Type 1 diabetes considered "low risk" for heart problems, and 16 people with Type 1 diabetes considered "high risk" for heart problems. The trial was measuring blood flow to the heart muscle under stress conditions, comparing results between people with and without Type 1 diabetes. Most participants completed the study — one person from each group did not finish. The reported data shows that the main measurement was a ratio comparing heart blood flow during stress to blood flow at rest (a higher number suggests a greater increase in flow during stress). The non-diabetic group had a reported ratio of 2.19, the low-risk Type 1 diabetes group had a ratio of 1.81, and the high-risk Type 1 diabetes group had a ratio of 1.95. A secondary measurement looked at coronary flow reserve — a similar kind of stress-to-rest blood flow ratio — measured directly inside the heart's blood vessels in a subgroup labelled "Abnormal MPI Study"; the reported figure for that group was 1.5. A further secondary measurement using a nuclear imaging technique (which uses a small amount of radioactive material to take pictures of the heart) also compared stress-to-rest counts: the non-diabetic group recorded 1.09, the low-risk diabetes group recorded 1.40, and the high-risk diabetes group recorded 1.12. These numbers reflect what was recorded in this small study, and no safety or broader outcome data was included in what was submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01513590 · results posted 20 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 197 people in each of two groups — one group received a insulin called IDegAsp (given twice daily) and the other received an insulin called BIAsp 30 (also given twice daily). In total, 394 people started the trial. The main thing the trial was measuring was the change in a blood test called HbA1c — a measure of average blood sugar levels over the previous few months — after 26 weeks. Several other things were also tracked, including fasting blood sugar levels, body weight changes, and the number of episodes where blood sugar dropped too low (called hypoglycaemic episodes). The reported data shows that, after 26 weeks, the average HbA1c level fell by 1.85 percentage points in the IDegAsp group and by 1.73 percentage points in the BIAsp 30 group. For fasting blood sugar levels, the reported reduction was 4.44 mmol/L in the IDegAsp group and 3.03 mmol/L in the BIAsp 30 group. Regarding body weight, participants in the IDegAsp group gained an average of 2.8 kg, compared with 2.0 kg in the BIAsp 30 group. When it came to episodes of low blood sugar overnight (between 12:01 am and 5:59 am), the IDegAsp group recorded 60 episodes in total, compared with 260 in the BIAsp 30 group. For all low blood sugar episodes (day and night combined), the IDegAsp group recorded 553 episodes, compared with 1,221 in the BIAsp 30 group. Finally, 77 participants in the IDegAsp group and 59 in the BIAsp 30 group reached an HbA1c below 7.0% without experiencing any low blood sugar episodes in the final 12 weeks of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01045707 · results posted 20 November 2015

According to the results reported on ClinicalTrials.gov, this trial involved two groups of people with diabetes who were each given a once-daily insulin injection — one group received an insulin called IDegAsp (266 people) and the other received an insulin called IGlar (264 people). The trial ran in two parts: a main 26-week phase and an extension phase out to 52 weeks. The trial was measuring changes in a blood marker called HbA1c (a measure of average blood sugar levels over roughly three months), self-measured blood sugar readings, and the rate of low blood sugar episodes (called hypoglycaemia — when blood sugar drops too low). The reported data shows that after 26 weeks, both groups had lower HbA1c levels than when they started: the IDegAsp group's HbA1c fell by an average of 1.65 percentage points, and the IGlar group's fell by 1.72 percentage points. After 52 weeks, both groups again showed reductions from their starting levels — 1.39 percentage points for IDegAsp and 1.34 for IGlar. Average self-measured blood sugar readings at 26 weeks were 7.9 mmol/L in both groups. For low blood sugar episodes over the extension period, the reported rate was 419 episodes per 100 patient-years for the IDegAsp group and 211 for the IGlar group. For low blood sugar episodes occurring overnight specifically, the IDegAsp group had a reported rate of 19 per 100 patient-years compared to 53 for the IGlar group. The rate of adverse events (any unwanted medical occurrences) was also recorded, with 313 events per 100 patient-years in the IDegAsp group and 238 in the IGlar group; further breakdowns by severity were reported but the data as submitted contains multiple overlapping figures that cannot be clearly separated. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00978627 · results posted 20 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 366 people in the IDegAsp OD group (a combination insulin given once daily) and 182 people in the IDet group (a different insulin) at the start of the main 26-week period. A smaller number then continued into an extension phase running to 52 weeks. The trial was measuring changes in blood sugar control — using a marker called HbA1c, which reflects average blood sugar levels over roughly three months — as well as how often participants experienced low blood sugar episodes (hypoglycaemia) during treatment. The reported data shows that after 26 weeks, average HbA1c levels fell by 0.73 percentage points in the IDegAsp OD group and by 0.68 percentage points in the IDet group, both measured from where they started. The average blood sugar across nine daily self-checks at week 26 was reported as 8.0 mmol/L for IDegAsp OD and 8.4 mmol/L for IDet. For low blood sugar episodes during the main period, the reported rates were 3,917 episodes per 100 patient-years for IDegAsp OD and 4,434 for IDet (patient-years is simply a way of accounting for the total time all participants spent in the trial). In the extension phase (out to 52 weeks), the reported HbA1c change from the original starting point was −0.65 for IDegAsp OD and −0.56 for IDet. The overall low blood sugar episode rate in the extension was 3,183 versus 3,673 per 100 patient-years, and for episodes occurring overnight specifically (between 12:01 am and 5:59 am), the reported figures were 309 for IDegAsp OD and 541 for IDet. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01009580 · results posted 20 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 224 people in the IDegAsp twice-daily group and 223 people in the BIAsp 30 twice-daily group — a total of 447 participants. Both groups were using insulin to manage their blood sugar, and the trial ran for 26 weeks. The main thing being measured was a blood test called HbA1c, which gives an average picture of blood sugar levels over roughly two to three months. A number of additional things were also tracked, including average daily blood sugar readings and how often participants experienced low blood sugar episodes (called hypoglycaemia). The reported data shows that after 26 weeks, both groups had lower HbA1c levels than when they started. The IDegAsp group's HbA1c fell by an average of 1.28 percentage points, and the BIAsp 30 group's fell by an average of 1.30 percentage points. For the secondary measures, the average blood sugar reading across nine daily time points was reported as 7.0 mmol/L for the IDegAsp group and 7.3 mmol/L for the BIAsp 30 group. The reported data shows that confirmed low blood sugar episodes occurred at a rate of 972 per 100 patient-years in the IDegAsp group, compared with 1,396 per 100 patient-years in the BIAsp 30 group. For low blood sugar episodes occurring overnight specifically (between 12:01 am and 5:59 am), the reported rates were 74 per 100 patient-years for IDegAsp and 253 per 100 patient-years for BIAsp 30. (Patient-years is simply a way of accounting for the total time all participants spent in the trial.) These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00612040 · results posted 16 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 178 people across three groups to compare two formulations of an insulin called SIBA — referred to as SIBA (D) and SIBA (E) — against a comparator insulin called IGlar (insulin glargine). Each group started with 59–60 participants. The trial ran for 16 weeks and was primarily measuring changes in a blood sugar marker called HbA1c (a percentage figure that reflects average blood sugar levels over roughly 2–3 months). A number of secondary measurements were also tracked, including fasting blood sugar levels, blood sugar readings taken at nine points throughout the day, and the rate of low blood sugar episodes (called hypoglycaemia). The reported data shows that after 16 weeks, average HbA1c fell by 0.54 percentage points in the SIBA (D) group, by 0.57 percentage points in the SIBA (E) group, and by 0.62 percentage points in the IGlar group. For fasting blood sugar levels, the reported reductions were 2.06 mmol/L, 1.60 mmol/L, and 0.54 mmol/L respectively. The overall average blood sugar across the nine daily measurement points was reported as 9.27, 9.56, and 9.04 mmol/L for the three groups. For low blood sugar episodes, the reported data shows rates of major episodes (where a person could not treat themselves) of 46, 41, and 36 per 100 patient-years across the three groups, while minor episodes were recorded at 5,838, 5,305, and 6,637 per 100 patient-years. Nocturnal (overnight) low blood sugar episodes followed a similar pattern, with major rates of 17, 12, and 18, and minor rates of 769, 546, and 1,082 per 100 patient-years. The reported data also includes rates of adverse events (unexpected medical occurrences during the trial) of 653, 874, and 914 per 100 patient-years across the three groups for all events combined, with serious adverse events reported at 6, 12, and 6 per 100 patient-years respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01074268 · results posted 16 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 303 people in the insulin degludec once-daily group (IDeg OD) and 153 people in the insulin detemir once-daily group (IDet OD). The trial ran in two parts: a main 26-week phase and a 52-week extension. It was measuring blood sugar control in people with diabetes, looking mainly at a blood marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly three months — as well as fasting blood sugar (measured after not eating overnight) and blood sugar readings taken at nine different points across the day. The reported data shows that after 26 weeks, the HbA1c percentage fell by an average of 0.73 percentage points in the IDeg OD group and 0.65 percentage points in the IDet OD group from where each group started. At 52 weeks, the reported falls from the original starting point were 0.46 and 0.47 percentage points respectively for the two groups. For fasting blood sugar (measured in millimoles per litre, or mmol/L), the reported change from the starting point after 26 weeks was a fall of 2.60 mmol/L in the IDeg OD group and 0.62 mmol/L in the IDet OD group; at 52 weeks those figures were a fall of 2.19 mmol/L and 0.82 mmol/L respectively. The nine-point daily blood sugar readings averaged 7.9 mmol/L (IDeg OD) and 7.8 mmol/L (IDet OD) at 26 weeks, and 7.8 mmol/L for both groups at 52 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01413542 · results posted 4 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 29 people across two groups. Group 1 (12 participants) looked at how blocking two different enzymes — one called ACE and one called DPP4 — affected blood flow in the forearm and other body responses when certain natural signalling chemicals (Substance P and Bradykinin) were infused directly into an artery in the arm. Group 2 (17 participants) examined similar questions using two other signalling chemicals (GLP-1 and BNP). The trial used a "crossover" design, meaning participants received both an active drug (sitagliptin, a DPP4 blocker) and a dummy (placebo) treatment at different times, so their responses could be compared. In total, 24 of the 29 participants completed the study; 5 did not complete it, though the reasons were not detailed in the reported data. The reported data shows the main measurement was forearm blood flow, expressed as an estimated difference in millilitres of blood per minute per 100 mL of forearm tissue. For Group 1, the reported difference in blood flow with sitagliptin versus placebo was 6.5 (units: mL/min/100mL) for one condition, 0.2 for another, 5.9, −0.6, 5.7, and 0.8 across the various peptide doses tested; several Group 2 measurements were listed as "not available" in the submitted data. For the secondary outcomes, the reported data shows differences in a clot-dissolving substance called tPA — with figures of 118.6 and 145.5 (ng/min/100mL) in males and females respectively under one condition, and varying figures across other conditions. Heart rate changes in Group 1 ranged from −1.8 to 4.55 beats per minute across conditions. A stress hormone called norepinephrine showed differences ranging from −52.18 to 23.45 pg/mL. In Group 2, blood levels of GLP-1 ranged from 5.13 to 30.63 pmol/L across conditions. The reported data shows these numbers as estimates of difference between treatment conditions, but the submitted results do not include enough detail (such as measures of statistical certainty) to draw firm conclusions from the figures alone. Some outcome values for Group 2 were listed as not available in the data submitted to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01774149 · results posted 16 September 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total, split into two groups of 15. One group received a system called "Diastat" straight away, while the other group (called "Delayed Diastat") waited before receiving it. The trial was looking at whether the system was linked to any change in the number of blood sugar readings that were either too high (above 15 mmol/L) or too low (below 4 mmol/L), comparing a starting period to a later measurement period of weeks 8 to 12. By the end of the study, 14 people in the Delayed Diastat group and 12 people in the Diastat group had completed the trial. The reported data shows that, for the primary outcome — the change in the number of out-of-range blood sugar readings — the Delayed Diastat group had a reported change of minus 18 events, and the Diastat group had a reported change of minus 7.5 events. These figures represent the average change from the starting period to the later measurement period, with a negative number meaning fewer out-of-range readings were recorded. For the secondary outcome, a measure called HbA1c (a blood test that gives an idea of average blood sugar levels over roughly three months) was also recorded. The reported data shows the Delayed Diastat group had a change of minus 0.57 percentage points, and the Diastat group had a change of minus 0.63 percentage points. Two other planned measures — usability of the system and a diabetes empowerment score — were listed in the trial but no results data was reported for those outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00119041 · results posted 12 May 2015

According to the results reported on ClinicalTrials.gov, this trial involved 304 people across three groups: 199 people at a telemedicine clinic, 83 people at a standard (control) clinic, and 22 healthcare providers who took part in interviews. All participants who started the study completed it — no one dropped out. The trial was measuring two things in the patient groups: blood sugar control (using a test called HbA1c, which shows the average level of sugar in the blood over a few months) and how satisfied patients were with their diabetes treatment. The reported data shows that for the HbA1c blood sugar measure, the telemedicine group started with an average score of 10.1% and finished at 8.82%, while the control group started at 9.32% and finished at 8.36%. (For context, a higher HbA1c percentage means higher average blood sugar levels.) For patient satisfaction, scores were measured on a scale of 0 to 36, where higher numbers mean greater satisfaction. The reported data shows the telemedicine group scored 24.33 at the start and 23.55 at the end, while the control group scored 23.29 at the start and 23.9 at the end. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01658579 · results posted 7 May 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 59 people across four groups, all of whom were testing two different insulin medications — HOE901-U300 (a newer insulin) and Lantus (an existing insulin) — given either in the morning or evening. The trial used a "crossover" design, meaning participants tried different combinations across two treatment periods. The main thing being measured was how much time participants spent with their blood sugar level in a target range (between 4.4 and 7.8 mmol/L), tracked using continuous glucose monitoring. The reported data shows that, on average, participants using HOE901-U300 spent about 31.75% of the time with their blood sugar in the target range, compared with about 30.99% for those using Lantus. For time spent *above* the target range, the reported figures were 58.24% for HOE901-U300 and 57.38% for Lantus. Time spent *below* the target range was reported as 10.01% for HOE901-U300 and 11.64% for Lantus. The reported data also shows that average blood sugar levels across the day were similar between the two insulins (8.869 mmol/L for HOE901-U300 and 8.910 mmol/L for Lantus). Changes in a longer-term blood sugar marker called HbA1c (a measure of average blood sugar over roughly three months) were also reported as small and broadly similar between the two groups across both treatment periods. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01986231 · results posted 30 April 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom received open-label glucagon (meaning everyone knew what treatment was being given — there was no comparison group). Eleven participants completed the trial and one did not. The trial was measuring whether repeated doses of glucagon changed the amount of glycogen (a form of stored sugar) in the liver. This was measured using a specialised scanning technique called Carbon-13 Magnetic Resonance Spectroscopy, which estimates how much glycogen is stored in the liver. The reported data shows two sets of measurements — one taken when participants had been fasting (not eating), and one taken after they had eaten. For the primary outcome, the reported mean difference in liver glycogen in the fasting state before versus after glucagon administration was 6.5 grams per litre (g/L). For the secondary outcome, the reported mean difference in liver glycogen in the fed state before versus after glucagon administration was 10.6 g/L. It is worth noting that the data as reported does not include the direction of these differences (i.e., whether glycogen levels went up or down), nor does it include a measure of variability across participants, so the full picture of what these numbers represent is limited based on the information submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01683266 · results posted 23 April 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01683266) enrolled 274 people in the HOE901-U300 group and 275 people in the Lantus group — a total of 549 participants. Both HOE901-U300 and Lantus are forms of long-acting insulin. The trial was measuring changes in blood sugar control over six months, primarily by looking at a measure called HbA1c — a blood test that reflects average blood sugar levels over roughly the past two to three months. The reported data shows that, for the main outcome, HbA1c levels fell by an average of 0.40 percentage points in the HOE901-U300 group and 0.44 percentage points in the Lantus group over six months. For the secondary outcomes, the reported data shows that 16.8% of people in the HOE901-U300 group and 15.0% in the Lantus group reached an HbA1c below 7% by six months. Reaching an HbA1c of 6.5% or below was reported for 8.1% and 5.5% of participants respectively. Blood sugar readings taken just before each insulin injection (measured by participants at home) fell by an average of 1.16 mmol/L in the HOE901-U300 group and 0.82 mmol/L in the Lantus group. The day-to-day variation in those pre-injection readings also decreased in both groups — by 3.03% in the HOE901-U300 group and 1.76% in the Lantus group. A separate fasting blood glucose test (taken in a clinical setting after not eating overnight) showed a fall of 0.95 mmol/L in the HOE901-U300 group and 1.14 mmol/L in the Lantus group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01439672 · results posted 14 April 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 35 participants in a single group focused on measuring insulin sensitivity — that is, how well the body responds to insulin after eating a mixed meal. Of the 35 people who started the trial, 11 completed it, and 24 did not complete it. The trial tracked how the body processed glucose (blood sugar) and insulin over time following a meal, using frequent blood samples taken roughly every 5 to 15 minutes. The reported data shows one primary outcome was measured: insulin sensitivity, using a method called the "minimal model of glucose kinetics." This is a mathematical approach that uses the blood sugar and insulin readings to estimate how efficiently the body is using insulin. The reported result for this measurement was 3.37×10⁻⁴ units (expressed as 1/min per µU/mL, which is the standard unit used for this type of calculation). No secondary outcome measures or additional breakdowns of the data appear to have been reported in the submitted results. It is worth noting that because 24 out of 35 participants did not complete the trial, the final number of people contributing to the reported result was relatively small. No further detail about why participants did not complete the trial was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01183468 · results posted 16 January 2015

According to the results reported on ClinicalTrials.gov, this trial was studying a medicine called Aralast NP in people with what appears to be a condition affecting insulin production (based on the type of measurement used). The trial was split into different age groups: one group included people aged 16–35 years, and another included people aged 8–15 years. Two further groups (aged 18–35 and 8–17) were also listed but had no participants enrolled. In total, 17 people started the trial across the two active groups — 8 in the older age group and 9 in the younger age group. Of those, 5 and 7 participants respectively completed the study. The main thing the trial set out to measure was a marker of the body's own insulin production (called "C-peptide"), assessed at 52 weeks using a standard meal-based test. However, the reported data shows that no results are available for this primary outcome. According to the results reported on ClinicalTrials.gov, the trial was terminated before participants reached the 52-week time point, meaning the key measurement the study was designed to capture was never collected. Because the trial ended early, the reported data does not include any outcome numbers for the primary measure, and no secondary outcome data appears to have been submitted. The reasons for early termination are not detailed in the results data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00592072 · results posted 5 January 2015

According to the results reported on ClinicalTrials.gov, this trial involved 12 adults with type 1 diabetes. It was a "crossover" trial, meaning each participant tried both conditions at different times — one period where they took a medium chain triglyceride (MCT) oil drink, and one period where they took a plain control drink, with a washout break in between. Two people dropped out during the washout period, so 10 participants completed both phases. The trial was measuring whether MCT oil might affect how well the brain performs on memory and thinking tests during a low blood sugar episode (hypoglycaemia), based on the idea that the brain might be able to use a different type of fuel from MCT oil when blood sugar is low. The reported data shows results across six thinking and memory tests, each scored on a numbered scale where a higher score represents better performance. For "Immediate Verbal Memory" (scale 0–25), participants scored 15.85 with MCT oil and 17.36 without it during normal conditions, and 14.97 with MCT oil versus 13.28 without it during low blood sugar. For "Delayed Verbal Memory" (scale 0–25), scores were 14.82 with MCT oil and 15.33 without during normal conditions, and 14.80 with MCT oil versus 11.58 without during low blood sugar. For "Verbal Memory Recognition" (scale 0–15), scores were 13.19 with MCT oil and 14.27 without in normal conditions, and 13.29 with MCT oil versus 12.14 without during low blood sugar. For "Digit Span Backward" (scale 0–35), scores were 0.60 with MCT oil and 0.64 without in normal conditions, and 0.58 with MCT oil versus 0.54 without during low blood sugar. For "Letter/Number Sequencing" (scale 0–21), scores were 12.04 with MCT oil and 11.07 without in normal conditions, and 10.97 with MCT oil versus 9.92 without during low blood sugar. For "Digit Symbol Coding" (scale 0–133), scores were 72.50 with MCT oil and 74.04 without in normal conditions, and 74.99 with MCT oil versus 68.56 without during low blood sugar. The reported data does not include any further statistical analysis or context to explain the differences between the numbers. No information about side effects or safety outcomes was reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01848990 · results posted 29 October 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 456 people in total across three groups: 227 used a commercial version of Hylenex Recombinant (a substance added to insulin to help it absorb under the skin), 115 used an earlier pre-commercial version of the same substance, and 114 used standard rapid-acting insulin delivered by a continuous pump (a small device worn on the body). The trial was measuring changes in blood sugar control over 6 and 12 months, using a test called HbA1c — a measure of average blood sugar levels over roughly three months — as well as tracking how often participants experienced episodes of blood sugar going too low (hypoglycaemia) or too high (hyperglycaemia). The reported data shows that for the primary measure — change in HbA1c — the Hylenex Recombinant group's average score dropped by 0.14 percentage points at 6 months and 0.13 percentage points at 12 months. The standard insulin pump group's average score dropped by 0.18 percentage points at 6 months and 0.26 percentage points at 12 months. For the secondary measures, the reported data shows that low blood sugar episodes (blood glucose at or below 70 mg/dL) occurred at a rate of approximately 2.91 events per person per month in the Hylenex group and 4.20 in the standard pump group up to 6 months; at 12 months those figures were approximately 2.68 and 3.30 respectively. Severe low blood sugar events — those requiring help from another person — were reported at very low rates in both groups (around 0.006 and 0.016 per person per month to 6 months). High blood sugar episodes (above 240 mg/dL) were reported at roughly similar rates in both groups, around 18 events per person per month across both time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00694122 · results posted 21 October 2014

According to the results reported on ClinicalTrials.gov, this trial involved 27 people in total across two groups, though only 15 completed the full study. It was a "crossover" trial — meaning each participant tried both insulin types, one after the other — comparing two long-acting insulin medications used for diabetes: glargine (brand name Lantus) and NPH insulin. The trial monitored participants overnight, from 10 pm to 8 am, tracking their blood sugar levels and several hormones hour by hour. There was a short one-day washout period between the two treatment phases. The reported data shows that the main thing being measured was overnight blood sugar. The average blood sugar level during the overnight period was reported as 9.6 mmol/L while participants were on glargine (Lantus), and 7.9 mmol/L while on NPH insulin. A related measure — the total "area under the curve" (a way of adding up all the blood sugar readings across the whole overnight period) — was reported as 1,673 units for glargine and 1,395 units for NPH. The reported data also shows that the insulin doses given were similar between the two groups: around 20.2 units for glargine and 20.7 units for NPH. For the hormone measurements taken overnight, cortisol levels were reported as 380 versus 389 nmol/L, glucagon as 58.8 versus 54.3 mcg/L, and growth hormone as 1.09 versus 1.27 ug/L, for glargine and NPH respectively. It is worth noting that a significant number of participants did not complete the first phase of the trial (10 out of 20 in one group, and 2 out of 7 in the other), and the reasons for this were not reported in the data available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01421147 · results posted 9 October 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 269 people in the LY2963016 group and 267 people in the Lantus group — a total of 536 participants — all of whom also received a fast-acting insulin called insulin lispro alongside their assigned basal insulin. LY2963016 is a biosimilar (a very close copy) of the well-known basal insulin Lantus (insulin glargine). The trial was primarily measuring changes in a blood marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly the past two to three months — after 24 weeks of treatment. The trial also included an extension period, with the majority of participants continuing through to that stage. The reported data shows that, for the primary outcome at 24 weeks, average HbA1c fell by 0.35 percentage points in the LY2963016 group and by 0.46 percentage points in the Lantus group, from their starting levels. These figures were calculated using a statistical method that adjusted for several background factors. For body weight, the reported data shows a gradual increase in both groups over time; by the final timepoint measured, the LY2963016 group had an average increase of approximately 0.93 kg and the Lantus group approximately 0.59 kg from their starting weight. Blood sugar readings taken by participants themselves at seven set points during the day were broadly similar between the two groups across most time points, ranging roughly between 7.9 and 9.4 mmol/L depending on the time of day and group. Changes in insulin antibody levels (proteins the body can produce in response to insulin) were also measured and appeared small in both groups, though the data was not reported in a way that allows straightforward summarising of a single overall figure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01600950 · results posted 7 October 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in total, split into two groups of 10. It used a "crossover" design, meaning each person received both treatments — one called LY2963016 (a candidate insulin glargine medicine) and the other Lantus (an already-approved insulin glargine) — in different periods, with all 20 participants completing both periods. The trial was measuring how the two insulins behaved in the body over time, using a controlled laboratory technique called a "euglycaemic clamp," where researchers carefully infuse glucose (sugar) into the bloodstream to keep blood sugar at a steady target level while the insulin is active. This allowed them to track how long each insulin acted and how strongly it appeared to act. The reported data shows that for the main (primary) outcome — how long the insulin kept blood sugar below a set threshold of 150 mg/dL — LY2963016 had a reported duration of about 37 hours, while Lantus had a reported duration of about 40 hours. For the secondary outcomes, the peak rate of glucose that needed to be infused to keep blood sugar steady (a measure of the insulin's peak activity) was reported as 0.530 mg/kg/min for LY2963016 and 0.611 mg/kg/min for Lantus. The total amount of glucose infused over the whole clamp period was reported as 4.60 mg/kg for LY2963016 and 6.52 mg/kg for Lantus. The time at which that peak activity was reached was reported as approximately 9.9 hours for LY2963016 and 11.7 hours for Lantus. Two other planned measurements — related to how much of each insulin was detectable in the blood — were not reported, as the data noted that concentrations fell below the detectable limit of the test used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00883558 · results posted 8 September 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 48 people in total. It used a "crossover" design, meaning participants tried both treatments — one called INSULIN-PH20 NP (an insulin combined with an enzyme called PH20) and one called Insulin Lispro (a standard fast-acting insulin) — in different orders, with a settling-in period at the start. The trial was mainly measuring how much blood sugar levels rose after meals (known as a "postprandial glucose excursion" — essentially, the difference between blood sugar just before eating and two hours after). The reported data shows that, on average, blood sugar rose by about 17.2 mg/dL (milligrams per decilitre, a standard unit for measuring blood sugar) after meals in the INSULIN-PH20 NP group, compared with about 14.5 mg/dL in the Insulin Lispro group. For a secondary measure — the total time each day that blood sugar was outside a target range of 71–139 mg/dL, as tracked by a continuous monitoring device — the reported figures were approximately 14.6 hours for INSULIN-PH20 NP and 13.4 hours for Insulin Lispro. Regarding low blood sugar episodes (hypoglycaemic events), the reported data shows 45 out of 46 participants experienced at least one such episode while on INSULIN-PH20 NP, and 43 out of 46 while on Insulin Lispro. Two participants had a severe low blood sugar episode (one serious enough to need help from another person) during the INSULIN-PH20 NP period, compared with none during the Insulin Lispro period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01434030 · results posted 25 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 57 participants in a single group called "Behavioral Observer," with 56 completing the study and 1 not completing it. The trial was measuring people's attitudes toward a concept called a Personal Glucose Advisory System (PGASystem) — essentially an automated system that could give personalised advice based on blood glucose (blood sugar) readings. Specifically, the study looked at whether participants wanted to receive different types of advice from such a system, and whether they said they would follow that advice. The reported data shows that when asked about their desire to receive various types of information from a PGASystem, the percentages of participants who said they would like each type of information were 100%, 92.9%, 94.6%, and 85.7% across the four categories measured (the specific labels for each category were not included in the submitted data). For the secondary outcome — whether participants said they would actually follow the advice given by a PGASystem — the reported figures across three categories were 53.6%, 60.4%, and 44.2% of participants. It is worth noting that wanting to receive information and saying one would follow it appear to have been measured separately, and the category labels for these measurements were not detailed in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01973413 · results posted 15 August 2014

According to the results reported on ClinicalTrials.gov, this trial involved two groups of young people with type 1 diabetes. Twelve participants took part in an inpatient study (one did not complete it), and 20 participants took part in a diabetes camp study (all 20 completed it). The trial was measuring how well a "closed-loop" insulin delivery system — where a device automatically adjusts insulin based on continuous glucose readings — kept blood sugar levels within a target range overnight, compared to a "sensor-augmented pump," where the pump delivers insulin but a person or carer still makes manual adjustments. The reported data shows that the main outcome being measured was the percentage of overnight time that participants' blood sugar stayed within a target range of 70–150 mg/dL (a range considered close to normal). During the camp study, the closed-loop group spent around 73% of overnight time within that range, compared to 52% for the sensor-augmented pump group. The reported data also shows that the average overnight blood sugar reading was 140 mg/dL for the closed-loop group and 147 mg/dL for the sensor-augmented pump group. For low blood sugar events overnight, the reported data shows 4 nights with at least one event in the closed-loop group and 4 nights in the sensor-augmented pump group. For high blood sugar events overnight, 7 nights were recorded in the closed-loop group compared to 14 nights in the sensor-augmented pump group. It is worth noting that the trial excluded some nights of closed-loop data where technical problems occurred (such as pump or sensor failures lasting more than 60 minutes), so the figures above reflect nights when the technology was working as intended. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01206101 · results posted 3 July 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01206101) enrolled a total of three people — two in the liraglutide group and one in the liraglutide placebo group. The trial was designed to look at whether liraglutide (an injectable medicine) could support islet cell transplantation — a procedure where insulin-producing cells from a donor are transplanted into a person with diabetes — by measuring things like whether people could stop using insulin after a single-donor transplant, how often low blood sugar episodes occurred, and how stable blood sugar levels were over time. The reported data shows that none of the three participants completed the trial — all three are recorded as "not completed." Because of this, no results were reported for any of the outcome measures, including the primary outcome (the proportion of people who became insulin-independent after a single transplant) and all of the secondary outcomes (such as the number of low blood sugar episodes, blood sugar control at 52 weeks, and continuous glucose monitoring readings). The data was not reported for any of these measures, meaning no numbers are available from this trial. This appears to have been a very small trial that did not reach its intended size and did not produce any reportable outcome data. No conclusions can be drawn from these figures about the transplant procedure or the medicine being studied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00844519 · results posted 19 June 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 52 people in total — 26 received a medicine called maraviroc and 26 received a placebo (a dummy treatment with no active ingredient). The trial was measuring a specific aspect of blood vessel function called flow-mediated vasodilation (FMD), which is a way of assessing how well the lining of blood vessels responds to changes in blood flow. Most participants completed the study — 24 in the maraviroc group and 25 in the placebo group. The reported data shows that the primary outcome — the percentage change in FMD — was 0.57% in the maraviroc group and -0.05% in the placebo group. In plain terms, the maraviroc group showed a very small increase in this blood vessel measurement, while the placebo group showed a very small decrease. No additional outcome measures were included in the structured data submitted, so further details beyond this single measurement were not reported in the dataset provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00252720 · results posted 3 June 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 951 people in the candesartan (the medicine being tested) group and 954 people in the placebo (dummy pill) group — a total of 1,905 participants. The trial was measuring whether candesartan had any effect on diabetic eye disease (diabetic retinopathy), specifically looking at whether the condition got worse, whether it improved, and whether serious complications developed over time. The reported data shows that for the main outcome — the number of people whose eye disease worsened by a meaningful amount on a standardised 11-step grading scale — 127 participants in the candesartan group and 124 in the placebo group reached that threshold. For the secondary outcomes, the number of participants whose eye disease showed meaningful improvement was 140 in the candesartan group and 139 in the placebo group. When looking at serious eye complications (macular oedema, which is swelling at the centre of the eye, and proliferative diabetic retinopathy, a more advanced stage of the disease), 110 people in the candesartan group and 107 in the placebo group experienced these events. The trial also measured changes in a urine protein marker (urinary albumin excretion rate, which can reflect kidney strain related to diabetes), reporting an average annual rate of change of 0.569 units in the candesartan group compared with 0.642 units in the placebo group; however, what this difference means clinically was not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01497938 · results posted 17 March 2014

According to the results reported on ClinicalTrials.gov, this trial involved 247 people in total — 121 in the group using a "Low Glucose Suspend" (LGS) insulin pump feature (which automatically pauses insulin delivery when blood sugar drops low) and 126 in a control group without that feature turned on. The trial was measuring two main things: whether using the LGS feature was linked to any change in longer-term blood sugar levels (using a measure called A1C, which reflects average blood sugar over roughly three months), and whether the feature was associated with a difference in the extent of low blood sugar episodes during the night. The reported data shows that, for the A1C measure, the group with LGS turned on had an average change of 0.00% from the start to the end of the study, while the control group had an average change of −0.04%. In plain terms, both groups' A1C levels stayed almost identical to where they started. For the nighttime low blood sugar measure, the trial used a calculation called "event area under the curve" (a way of capturing both how low blood sugar dropped and for how long during episodes at night). The reported data shows the LGS group recorded a value of 980 mg/dL × minutes, compared with 1,568 mg/dL × minutes in the control group — meaning the LGS group's nighttime low blood sugar episodes, as captured by this calculation, were recorded as lower in magnitude overall. It is worth noting that 5 participants in the LGS group and 2 in the control group did not complete the study; the reasons were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01272583 · results posted 17 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 16 people in total — 8 in each of two groups. It used a "crossover" design, meaning each participant took both sitagliptin (a diabetes medication) and a placebo (a dummy pill) at different times, so every person could be compared under both conditions. The trial was measuring how the body's hormones respond during an episode of low blood sugar (hypoglycaemia), with a particular focus on glucagon — a hormone that normally helps raise blood sugar levels back up. The reported data shows that for the main outcome (glucagon response), the area measured over 40 minutes after the low blood sugar episode was 125 pmol\*min/L during sitagliptin treatment, compared with 120 pmol\*min/L at baseline and 120 pmol\*min/L during placebo. A separate glucagon measure — the change in concentration from the start to 40 minutes after the episode — was reported as 1.0 pmol/L for sitagliptin, compared with 1.33 pmol/L at both baseline and placebo. For the secondary outcomes, the reported data shows that epinephrine (adrenaline) levels over that 40-minute window were 32.6 nmol\*min/L on sitagliptin versus 58.7 nmol\*min/L on placebo and 36.1 at baseline. Norepinephrine figures were similar across all three conditions (around 62–70 nmol\*min/L). Growth hormone levels were reported as 261.5 mU\*min/L on sitagliptin, compared with 1,299 at baseline and 1,406 on placebo. Several hormone measurements related to GLP-1 and GIP were also reported across the three conditions, with the full set of figures available in the trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01460446 · results posted 6 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 218 people with diabetes across two groups: 105 used the Aviva Expert blood glucose meter (which includes a built-in "bolus advisor" — a tool that suggests insulin doses) and 113 used the Aviva Nano blood glucose meter (a standard meter without this feature). The trial ran for 24 weeks and was primarily measuring changes in a blood marker called HbA1c — a blood test that reflects average blood sugar levels over roughly three months — as well as several other blood sugar-related measures. By the end of the study, 100 people in the Expert group and 93 in the Nano group had completed the trial. The reported data shows that, on average, HbA1c levels fell by 0.66 percentage points in the Aviva Expert group and by 0.47 percentage points in the Aviva Nano group over 24 weeks. For the secondary measures, the reported data shows that at the start of the study, around half of all blood glucose readings in both groups (50.6% for the Expert group and 50.7% for the Nano group) fell within the target range of 3.9–10 mmol/L; by weeks 23–24, this was 49.3% for the Expert group and 52.2% for the Nano group. Regarding low blood sugar episodes (defined as readings below 3.9 mmol/L with symptoms), the Expert group recorded 18.9 episodes per person per year at the start and 17.0 by weeks 23–24, while the Nano group recorded 23.2 at the start and 15.8 by weeks 23–24. A measure of blood sugar swings (called MAGE, which captures how much glucose levels fluctuate) was tracked in roughly one-third of participants using a continuous glucose monitor; the reported change from baseline showed a reduction of 20.2 mg/dL in the Expert group and 2.9 mg/dL in the Nano group. For the Expert meter's bolus advisor feature specifically, the reported data shows it was used in 73.5% of opportunities where it was available, and participants adjusted the suggested dose on approximately 0.3 occasions per day on average. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00836407 · results posted 10 December 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people with pancreatic cancer — 15 in each of two groups. One group received a drug called ipilimumab on its own, and the other received ipilimumab combined with a pancreatic cancer vaccine. The trial was primarily measuring how often participants experienced serious, unacceptable side effects from treatment. It also looked at how long participants lived overall (overall survival), and whether tumours shrank or disappeared — though some of those secondary measurements were not reported in the submitted data. The reported data shows that in both groups, approximately 6.67% of participants (roughly one person in each group of 15) experienced what the trial defined as an unacceptable side effect. For overall survival — meaning the time from entering the trial until death or the end of follow-up — the reported figure was 3.6 months for the ipilimumab-alone group and 5.7 months for the ipilimumab-plus-vaccine group. The reported data shows that several other planned measurements, including tumour response rates and progression-free survival (how long before the disease worsened), were not submitted with any numerical results, so those figures cannot be described here. It is also worth noting that of the 30 people who started the trial, only 4 in the ipilimumab-alone group and 7 in the combination group were recorded as having completed it — the remaining participants did not complete the study, though the reasons were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00760526 · results posted 4 December 2013

According to the results reported on ClinicalTrials.gov, this trial involved 146 people with diabetes — 74 in a group using continuous glucose monitoring (a device that tracks blood sugar levels around the clock) and 72 in a group using a standard home blood glucose meter. Most participants finished the trial: 69 in the continuous monitoring group and 68 in the standard monitoring group. The trial's main question was how many people in each group achieved a meaningful drop in their HbA1c (a blood test that reflects average blood sugar levels over roughly three months — specifically a drop of 0.5% or more) without experiencing any severe hypoglycaemic events (dangerously low blood sugar episodes). The reported data shows that, for the primary outcome, 13 out of 74 participants in the continuous glucose monitoring group and 19 out of 72 participants in the standard monitoring group met that combined goal. For the secondary outcomes, the continuous monitoring group recorded 3 severe low blood sugar events compared with 6 in the standard monitoring group. Sensor readings showing blood sugar in a target range (71–180 mg/dL) were reported at 48% of readings for continuous monitoring and 49% for standard monitoring. Readings showing very low blood sugar (at or below 70 mg/dL) made up 1.5% of sensor readings in the continuous monitoring group and 2.1% in the standard monitoring group. A measure of how much blood sugar levels varied from person to person (standard deviation, in mg/dL) was reported as a median of 73 for continuous monitoring and 81 for standard monitoring. The average rate at which blood sugar levels changed per minute was reported as 0.91 mg/dL per minute for continuous monitoring and 0.90 mg/dL per minute for standard monitoring. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00340678 · results posted 19 November 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 170 people across four groups. Participants either had normal levels of a protein called albumin in their urine (normoalbuminuria) or slightly raised levels (microalbuminuria — an early sign that the kidneys may be under stress). Within each of those two categories, people were randomly assigned to receive either a medicine called losartan or a placebo (a dummy treatment with no active ingredient). The trial followed participants for up to six years, and the main thing it was measuring was whether kidney filtering ability — called GFR, which stands for glomerular filtration rate, a measure of how well the kidneys clean the blood — dropped to a notably low level. The reported data shows that very few participants in any group experienced a significant decline in kidney filtering ability over the study period. In the normal-albumin groups, 2 out of 46 people taking losartan and 2 out of 46 people taking the placebo reached that threshold. In the raised-albumin groups, 1 out of 39 people taking losartan and 4 out of 39 people taking the placebo reached it. The trial also measured glomerular volume — the average size of tiny filtering units inside the kidneys. The reported figures were 5.4 units for the normal-albumin losartan group, 5.6 for the normal-albumin placebo group, 6.4 for the raised-albumin losartan group, and 7.0 for the raised-albumin placebo group. No further context or explanation for these volume figures was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01488877 · results posted 23 September 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT01488877) tested an investigational medicine called PF-03882845 (at a 3 mg dose) compared to a placebo (an inactive treatment). It was a very small trial — only 6 people took part in the initial phase (1 on placebo, 5 on PF-03882845), and 3 additional participants entered through a separate re-randomisation stage under a spironolactone placebo group. The trial's main focus was on measuring levels of potassium in the blood — a mineral that needs to stay within a certain range — over roughly two weeks. The reported data shows that at Day 8, the average blood potassium level was 4.78 units (mEq/L) for the placebo group and 4.90 for the PF-03882845 group, with both groups showing a small increase from their starting levels (0.20 and 0.25 units respectively). By Day 15, the reported change from the starting level was 0.40 units for the placebo group and 0.25 units for the PF-03882845 group. Regarding episodes of high potassium (called hyperkalemia — where potassium rises above a defined threshold), the reported data shows that 2 out of 2 placebo participants and 5 out of 5 PF-03882845 participants had at least one confirmed high-potassium reading; 1 participant in the PF-03882845 group had a severe high-potassium episode, compared to none in the placebo group. For blood pressure and pulse rate at Day 15, the reported numbers showed modest changes in both groups, though the pharmacokinetic (drug absorption and processing) data was listed as not reported in the submitted results. It is important to note that this was an extremely small trial, and no firm conclusions can be drawn from such limited numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00129259 · results posted 16 September 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 77 people in total — 52 in the group that received an experimental drug called Anti-CD3 monoclonal antibody (mAb) alongside standard diabetes care, and 25 in the group that received standard diabetes care alone. The trial was measuring changes over 24 months in three things: the pancreas's ability to produce insulin (measured using a substance called C-peptide during a meal test), average blood sugar levels over time (measured by a test called HbA1c), and the amount of insulin that participants needed to inject each day relative to their body weight. Of the 52 people who started in the drug group, 49 completed the trial; of the 25 in the standard care group, 22 completed it. The reported data shows the following changes from the start of the trial to 24 months. For the main measurement — the C-peptide meal test, which indicates how much insulin the pancreas can still produce — the drug-plus-standard-care group showed a change of –0.28 pmol/mL, while the standard-care-only group showed a change of –0.46 pmol/mL (both figures represent a decline, with a smaller decline considered more favourable). For HbA1c (a measure of average blood sugar, where lower is generally more desirable for people with diabetes), the drug group changed by +0.129 percentage points and the standard-care group changed by +0.195 percentage points — both showing a small rise. For daily insulin dose relative to body weight, the drug group changed by +0.23 units per kilogram per day and the standard-care group changed by +0.35 units per kilogram per day — both groups requiring more insulin on average over the period. The reported data covers only these numerical changes and does not include information about what caused individual participants' results to differ. No safety or side-effect data was included in the structured results submitted to ClinicalTrials.gov for this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00437398 · results posted 16 April 2013

According to the results reported on ClinicalTrials.gov, this trial involved just 2 participants, both of whom completed the study. The trial was looking at islet transplantation — a procedure where insulin-producing cells are transplanted into a person — and was measuring two things: how often participants experienced hypoglycaemic episodes (episodes where blood sugar drops to an abnormally low level) after the transplant, and their HbA1c levels (a blood test that reflects average blood sugar control over roughly the previous three months). The reported data shows that, despite the trial being completed by both participants, no numerical results were submitted to ClinicalTrials.gov for either the primary outcome (number of low blood sugar episodes after transplant) or the secondary outcome (HbA1c levels since transplant). The data for both of these measures was not reported in the structured results available. Because no outcome numbers were provided in the submission, it is not possible to describe what the measurements showed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00542620 · results posted 18 January 2013

According to the results reported on ClinicalTrials.gov, this trial involved 25 people in total — 13 in a "Mixed Injection" group and 12 in a "Separate Injection" group — and all participants completed the study. The trial was comparing two ways of giving insulin injections to people with diabetes: mixing two insulins into one injection versus giving them as two separate injections. The main thing being measured was a blood test called HbA1c (glycosylated haemoglobin), which gives an indication of average blood sugar levels over roughly the past two to three months, expressed as a percentage. Researchers also measured fructosamine (another blood marker related to average blood sugar over a shorter period) and blood sugar levels at several points during the day. The reported data shows that, for HbA1c, the Mixed Injection group started at around 8.00% and finished at 7.63%, while the Separate Injection group started at 7.77% and finished at 8.15% — based on what is called the "Per Protocol" set (participants who followed the trial plan closely). A similar pattern was seen in the broader "Intention-to-Treat" analysis. For fructosamine, the Mixed Injection group went from 334.8 to 316.4 mmol/L, while the Separate Injection group went from 319.8 to 334.8 mmol/L. The reported blood sugar readings taken by participants themselves at various times of day also shifted across both groups between the start and end of the trial, with the specific numbers varying depending on the time of day measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00378508 · results posted 31 October 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 63 people in total — 34 were assigned to receive teplizumab (the active treatment) and 29 received saline infusions (the placebo, or dummy treatment). The trial was measuring how well the pancreas could still produce insulin, using a substance called C-peptide as a marker of that ability. Participants drank a standardised meal and their C-peptide levels were tracked over four hours. The trial also looked at a blood sugar control measure called HbA1c (a snapshot of average blood sugar levels over roughly three months) and how much insulin participants needed to inject each day. The reported data shows that at the start of the trial, C-peptide levels were similar between the two groups — 0.593 pmol/ml in the teplizumab group and 0.554 pmol/ml in the placebo group. After 12 months, the teplizumab group's reported C-peptide level was 0.451 pmol/ml compared with 0.371 pmol/ml in the placebo group (both figures adjusted for starting levels). For HbA1c at 12 months, the reported figures were 6.85% in the teplizumab group and 7.35% in the placebo group, compared with starting values of 6.32% and 7.1% respectively. The reported average daily insulin dose over the 12 months was 0.475 units per kilogram per day in the teplizumab group and 0.574 units per kilogram per day in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00842075 · results posted 19 October 2012

According to the results reported on ClinicalTrials.gov, this trial involved 10 people in total, split into two groups of 5. One group received a medicine called Symlin, while the other group continued with their usual treatment. The trial ran for 28 days and was measuring two things: a blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over roughly the past 2–3 months), and any change in body weight. The reported data shows that after 28 days, the Symlin group had an average HbA1c reading of 7.94%, while the usual treatment group had an average reading of 8.72%. For body weight, the reported data shows the Symlin group had an average change of −0.84 kg (meaning, on average, participants in that group weighed slightly less at the end), while the usual treatment group had an average change of +0.04 kg (meaning their weight was almost unchanged). No other outcome figures were reported in the submitted data. It is worth noting that this was a very small trial — just 5 people in each group — which means these numbers should be interpreted with a great deal of caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00831389 · results posted 11 October 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants in total, split into two groups of 6 and 7. It used a "crossover" design, meaning each person tried both approaches at different times: their usual standard of care (also called "open loop") and a "closed loop" system — an automated device that monitors blood sugar and adjusts insulin delivery on its own. The trial was measuring how blood sugar levels responded to exercise under each approach, including whether dangerous low blood sugar (below 60 mg/dL) occurred during or after exercise, and overnight. One participant did not complete the trial; the data was not reported on why. The reported data shows the following numbers. For the main (primary) outcomes: the drop in blood sugar from the start of exercise to its lowest point was reported as 75 mg/dL in the standard care phase and 90.5 mg/dL in the closed loop phase. The count of low blood sugar events immediately after exercise was zero in both phases, and the count of low blood sugar events overnight after exercise was also zero in both phases. For the secondary outcomes, the reported peak blood sugar after meals was 188 mg/dL in the standard care phase and 229.75 mg/dL in the closed loop phase. The lowest blood sugar recorded immediately after exercise was 80.5 mg/dL (standard care) and 70.5 mg/dL (closed loop). The lowest overnight blood sugar reading was 74.5 mg/dL in the standard care phase and 93.5 mg/dL in the closed loop phase. It is worth noting that these numbers come from a small group of participants, and the reported data shows results for each phase without additional context about individual variation. No data was reported that would allow conclusions about broader groups of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01112696 · results posted 27 August 2012

According to the results reported on ClinicalTrials.gov, this trial (NCT01112696) enrolled 100 participants in a single group, with 98 completing the study and 2 not completing it. The trial was measuring how accurately a glucose sensor read blood sugar levels compared to a laboratory reference test called YSI (a standard lab method used to measure blood glucose), looking at readings taken over the first six days of sensor use. The reported data shows that, among completed participants, 79.45% of paired sensor-and-laboratory readings met the accuracy target — meaning the sensor reading was within 20% of the laboratory result (or within 20 mg/dL when blood sugar was below 80 mg/dL). A higher percentage indicates closer agreement between the sensor and the lab standard. For the secondary outcome, the reported data shows that zero participants experienced a device-related adverse event (an unwanted health event judged by the study site to have a reasonable possibility of being caused by the device) that was rated as moderate or severe in its impact on daily activities. It is worth noting that only one group was studied, so these numbers describe that group's results only, with no comparison group reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00308139 · results posted 17 August 2012

According to the results reported on ClinicalTrials.gov, this trial involved 303 people in total — 152 started in a group taking exenatide once a week, and 151 started in a group taking exenatide twice a day. The trial was measuring changes in a blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over roughly three months), and tracked participants for up to 364 weeks (about seven years). At the 30-week point, 128 people in the once-weekly group and 130 in the twice-daily group had completed that stage. By the end of the full study, 58 and 64 people respectively were recorded as having completed it. The reported data shows that at 30 weeks, the once-weekly group's HbA1c had fallen by an average of 1.87 percentage points from where it started, while the twice-daily group's fell by an average of 1.54 percentage points. At week 30, around 70.9% of the once-weekly group and 51.0% of the twice-daily group had HbA1c readings below 7% — a commonly referenced target level. For the lower target of 6.5% or below at week 30, 3.0% of the once-weekly group and 16.3% of the twice-daily group reached that level. At the very end of the study (week 364), both groups had switched to once-weekly dosing, and the reported average HbA1c change from the original starting point was −1.49 percentage points for those who had been on once-weekly all along, and −1.57 for those who had switched from twice-daily, with an overall combined figure of −1.53 percentage points. A sub-study measuring how the body absorbed the medication from two different delivery devices did not have data reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00993473 · results posted 22 June 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 125 children and teenagers with Type 1 diabetes — 61 in the Lantus (insulin glargine) group and 64 in the NPH insulin group. The study ran for 24 weeks and was primarily measuring how often participants experienced low blood sugar episodes (called hypoglycaemia) while using each type of insulin. Low blood sugar was tracked in several ways: through symptom diaries, a continuous glucose monitoring device worn by participants, and fingerstick blood glucose checks. The reported data shows that for the main outcome — the overall rate of all types of low blood sugar episodes — the Lantus group recorded approximately 193 episodes per patient per year, while the NPH insulin group recorded approximately 169 episodes per patient per year. For secondary outcomes, the reported data shows that symptomatic low blood sugar (episodes where the child felt unwell) occurred at a rate of about 26 per patient per year in the Lantus group and about 33 per patient per year in the NPH group. Severe low blood sugar — meaning episodes serious enough to need help from someone other than a parent or usual carer, or involving seizure, unconsciousness, or glucagon use — was recorded at 0.14 events per patient per year for Lantus and 0.07 for NPH insulin. Overnight low blood sugar episodes occurred at roughly 34 per patient per year (Lantus) and 31 per patient per year (NPH), while overnight symptomatic episodes were about 2.4 (Lantus) versus 3.7 (NPH) per patient per year. Severe overnight low blood sugar was recorded at 0.04 events per patient per year for Lantus and 0.00 for NPH insulin. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00252733 · results posted 13 April 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,421 people in total — 711 received a medicine called candesartan and 710 received a placebo (a dummy pill with no active ingredient). The trial was looking at whether candesartan had any effect on diabetic eye disease (called diabetic retinopathy). The main thing being measured was how many participants experienced a meaningful worsening on a standard eye disease scale called the ETDRS scale, which runs from 1 (no eye disease) to 11 (severe eye disease). A "2-step or greater increase" on this scale was used as the marker for noticeable worsening. The reported data shows that, over the course of the study, 178 out of 711 participants in the candesartan group reached that 2-step worsening mark, compared with 217 out of 710 participants in the placebo group. The trial also measured changes in the amount of a protein called albumin in the urine over time — higher levels can be a sign of kidney stress in people with diabetes. The reported data shows the average yearly rate of change in this urine albumin measure was 0.510 (in the unit used by the study) for the candesartan group and 0.543 for the placebo group. These numbers are reported on a mathematical scale (the logarithm of micrograms per minute per year), and the reported difference between the two groups was small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00474045 · results posted 5 December 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 233 people in the insulin detemir group and 237 in the NPH insulin group — a total of 470 participants. All participants were women with type 1 diabetes who were either planning a pregnancy or became pregnant during the study. The trial was primarily measuring a blood sugar marker called HbA1c (glycosylated haemoglobin) — a percentage figure that reflects average blood sugar levels over roughly the previous two to three months — at week 36 of pregnancy. The reported data shows that at week 36 of pregnancy, the average HbA1c was 6.27% in the insulin detemir group and 6.33% in the NPH insulin group (under the "full analysis" approach), and 6.22% versus 6.37% respectively under a stricter "per protocol" analysis (which looked only at participants who followed the study plan most closely). For a secondary measure looking at how many participants reached an HbA1c at or below 6.0% at both week 24 and week 36 of pregnancy, the reported data shows 57 participants in the insulin detemir group and 46 in the NPH insulin group met that threshold. Fasting blood glucose levels (measured in mmol/L, a standard unit for sugar in the blood) were also tracked at several points during the study and are included in the reported data, with readings across different time points ranging from 4.7 to 5.2 mmol/L for insulin detemir and 5.4 to 6.3 mmol/L for NPH insulin. Self-monitored blood sugar readings taken at eight set times during the day were also recorded at week 24, with values across the eight time points ranging from 6.1 to 7.7 mmol/L for insulin detemir and 6.7 to 8.0 mmol/L for NPH insulin. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01029795 · results posted 26 October 2011

According to the results reported on ClinicalTrials.gov, this trial (NCT01029795) enrolled 38 adults with type 2 diabetes and compared two treatments: an investigational medicine called LY2599506 (16 participants) and an existing diabetes tablet called glyburide (22 participants). The trial was designed to measure changes in blood sugar control over 12 weeks, along with a range of other health markers including heart rhythm, insulin function, blood fats, and quality of life. Notably, the reported data shows that none of the participants were recorded as having "completed" the study — all 38 were listed under "not completed." The reported data shows that the trial was terminated early after enrolling those 38 participants. Because the number of people in each group was considered too small to produce meaningful or reliable figures, the researchers did not present numerical results for any of the outcome measures. This applies to the primary measure — change in a blood sugar marker called HbA1c (a measure of average blood sugar levels over roughly three months) — as well as all secondary measures, including heart rhythm (QT interval on an ECG), insulin and beta cell function, blood fat levels, and quality-of-life scores. The data was not reported for any of these outcomes, rather than figures being available but simply unfavourable. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00659295 · results posted 16 August 2011

According to the results reported on ClinicalTrials.gov, this trial looked at people with diabetes who were using an insulin called insulin detemir. It included two groups: 13,529 people with Type 1 diabetes and 37,641 people with Type 2 diabetes, making it a very large study. The trial tracked participants over different time periods — 3 months, 6 months, and 12 months, depending on the country — and not everyone completed the study (around 2,708 people with Type 1 diabetes and 5,603 people with Type 2 diabetes did not finish). The reported data shows that the main thing being measured was the number of people who experienced serious adverse reactions (that is, serious unwanted medical events) while using insulin detemir, including severe low blood sugar episodes (called major hypoglycaemic events) that were serious enough to be formally reported by their doctor. The reported numbers across the three time-period groups were: in the Type 1 diabetes group, 186, 208, and 109 participants experienced these serious reactions respectively; and in the Type 2 diabetes group, the corresponding numbers were 93, 112, and 48 participants. It is worth noting that the reported data states doctors did not always formally report every major low blood sugar episode as a serious adverse reaction, so the figures may not capture every such event that occurred. The reported data shows only the counts of these events as submitted — no comparison group or additional context about rates or outcomes beyond these numbers was included in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00211536 · results posted 23 June 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 107 people with diabetes — 53 in a group using an implantable insulin pump (called the MiniMed Implantable Pump, or MIP), and 54 in a group using standard under-the-skin (subcutaneous) insulin injections or pumps. The trial ran for 12 months and was mainly measuring two things: changes in a blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over roughly three months), and how often participants had a serious low blood sugar episode (defined as one severe enough to cause a seizure or coma, require hospitalisation, or need help from another person). The reported data shows that, for the HbA1c measure, the implantable pump group's average result changed by approximately −0.31 percentage points (a decrease), while the under-the-skin group's average changed by approximately +0.12 percentage points (an increase). For serious low blood sugar episodes over the 12 months, the reported data shows 2 events were recorded in the implantable pump group and 4 events in the under-the-skin group. The reported data also shows results for three secondary measures at 12 months. Average daily blood sugar levels were reported as 186.77 mg/dL for the implantable pump group and 195.8 mg/dL for the under-the-skin group. A measure of how much blood sugar levels swung up and down during the day (called MAGE) was reported as 136.27 mg/dL versus 149.2 mg/dL respectively. A score reflecting the risk associated with low blood sugar readings (called the Low Blood Glucose Index) was reported as 2.14 for the implantable pump group and 2.27 for the under-the-skin group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00530023 · results posted 10 June 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 29 people in total — 14 using a sensor-augmented insulin pump (a device that combines an insulin pump with a continuous glucose sensor) and 15 using multiple daily injections (MDI), which is the traditional approach of giving several insulin injections each day. One person in the MDI group did not complete the trial. The trial ran for 15 weeks and was primarily measuring changes in a blood sugar marker called A1C (a routine blood test that reflects average blood sugar levels over roughly three months, reported as a percentage). The reported data shows that, at week 15, the sensor-augmented pump group had an average A1C reduction of 1.7 percentage points from where they started, while the MDI group had an average reduction of 1.0 percentage point. For the secondary outcomes, the reported data shows zero severe low blood sugar episodes (episodes serious enough to need help from another person) in the pump group and one such episode in the MDI group over the 15 weeks. Participant satisfaction questionnaires — scored on a scale of 0 to 100, where higher means more satisfied — showed scores of 73.8 (pump) versus 41.0 (MDI) for satisfaction with the blood glucose monitoring system, and 83.3 (pump) versus 33.3 (MDI) for satisfaction with the insulin delivery system. A questionnaire measuring fear of low blood sugar episodes (where a lower score means less fear) reported a change of −10.57 in the pump group and −17.79 in the MDI group, meaning both groups reported less fear by week 15. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00601250 · results posted 7 June 2011

According to the results reported on ClinicalTrials.gov, this trial involved 700 people in total — 177 received a placebo (a dummy treatment with no active ingredient) and 523 received linagliptin, a type 2 diabetes medication. The trial ran for 24 weeks and was mainly measuring changes in a blood marker called HbA1c, which gives an indication of average blood sugar levels over roughly the previous two to three months. It is measured as a percentage, and the trial also tracked fasting plasma glucose (FPG) — a measure of blood sugar after not eating overnight, recorded in milligrams per decilitre (mg/dL). The reported data shows that, for the main measurement at 24 weeks, the placebo group's HbA1c percentage went up by an average of 0.15 percentage points from where it started, while the linagliptin group's HbA1c went down by an average of 0.49 percentage points. At the earlier check-in points, the reported data shows similar patterns: at 6 weeks the placebo group rose by 0.069 points while the linagliptin group fell by 0.363 points; at 12 weeks the placebo group rose by 0.096 points while the linagliptin group fell by 0.499 points; and at 18 weeks the placebo group rose by 0.147 points while the linagliptin group fell by 0.502 points. For fasting blood sugar at 24 weeks, the reported data shows the placebo group's reading rose by an average of 10.46 mg/dL, while the linagliptin group's fell by 10.68 mg/dL. At 6 weeks, the placebo group rose by 4.58 mg/dL and the linagliptin group fell by 11.94 mg/dL. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00211510 · results posted 29 April 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 146 adults with diabetes — 72 using the Paradigm 722 insulin pump (which included a continuous glucose sensor) and 74 using the Paradigm 715 insulin pump (without a sensor). The trial ran for 26 weeks and was primarily measuring changes in a blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over roughly three months). Most participants completed the study — 66 in the sensor pump group and 72 in the standard pump group. The reported data shows that both groups had a reduction in their HbA1c over the 26 weeks. The sensor pump group's HbA1c fell by an average of 0.72 percentage points, while the standard pump group's fell by 0.58 percentage points. For the secondary measurements, the sensor pump group recorded 11 episodes of severe low blood sugar (events needing another person's help) compared to 3 in the standard pump group. Both groups showed a reduction in time spent with very high blood sugar levels (above 180 mg/dL), with the sensor group showing a slightly larger reduction. For time spent with low blood sugar (below 70 mg/dL), the sensor group showed a small reduction while the standard pump group showed a small increase. Sensor reading accuracy in the sensor pump group was reported at 95.9% agreement with standard finger-prick readings. Scores on a questionnaire about fear of low blood sugar events changed only slightly in both groups — by −0.07 in the sensor pump group and −0.22 in the standard pump group — suggesting little change from baseline in either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00384085 · results posted 26 April 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 588 people across three groups — roughly 195 to 197 participants in each — and ran for 60 weeks (about 15 months). The trial was measuring blood sugar control in people with diabetes by tracking a blood marker called HbA1c (a measure of average blood sugar levels over roughly three months). The three groups each used a different insulin treatment routine, and the trial compared how these routines performed against each other. The reported data shows that when looking at the percentage of people who reached an HbA1c level below 7.0% (a commonly used target level) by the end of the trial, around 43% of people in the Lantus/Apidra-3 group reached that target, compared with around 39% in the Novolog Mix 70/30 group. In a separate comparison, around 51% of people in the Lantus/Apidra-1 group reached that target, versus around 40% in the Novolog Mix 70/30 group. For the change in HbA1c from the start to the end of the trial, the reported data shows the Lantus/Apidra-1 group went from an average of 9.30% down to a change of −2.30 percentage points, while the Novolog Mix 70/30 group started at 9.06% and showed a change of −1.97 percentage points. A secondary measure looked at the percentage of people who reached the HbA1c target without experiencing a serious low blood sugar episode; the reported figures ranged from about 14% to 25% across the three groups, depending on the comparison and time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00623194 · results posted 24 January 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 146 people who were all treated with a long-acting insulin called insulin detemir. Of those, 141 completed the study and 5 did not. The trial was primarily measuring whether antibodies — proteins the body can produce in response to a foreign substance — developed in participants' blood that could react to both insulin detemir and another insulin called insulin aspart. It also tracked several other measures over a period of up to 104 weeks (two years), including blood sugar control, body weight, and episodes of low blood sugar (hypoglycaemia). The reported data shows that the main measurement — cross-reacting antibodies — was recorded at multiple time points. The reported figures ranged from approximately 31% to 44% of total antibodies across the different measurement points. For antibodies specific to insulin detemir or insulin aspart alone, the reported figures were smaller, ranging from roughly 1.3% to 4.4% across the time points measured. At the two-year mark, the reported average HbA1c (a measure of longer-term blood sugar levels, where lower generally indicates closer-to-normal blood sugar) was 8.74%, and the average fasting blood sugar level was 7.71 mmol/L. The reported average Body Mass Index (a measure of body weight relative to height) was 18.88 kg/m². The reported data also shows that across the study, there were 10,530 mild, 450 moderate, and 7 severe low blood sugar episodes recorded in total, though the data as submitted does not break these down further in a way that allows a per-person rate to be clearly stated. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00519623 · results posted 30 December 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 9 people with type 1 diabetes, all of whom used a transdermal (stick-on skin) patch designed to deliver insulin through the skin — the PassPort® system. Eight participants completed the trial, and one did not. The trial was measuring two main things: how much insulin entered the bloodstream after the patch was applied (called pharmacokinetics), and how the body responded to that insulin in terms of blood sugar control (called pharmacodynamics). The reported data shows that the average peak level of insulin measured in the blood (that is, the highest concentration reached) was 33.0 uU/mL (a standard unit for measuring insulin in the blood). The average maximum rate at which glucose (sugar) needed to be delivered into the body to keep blood sugar steady at a target level of 100 mg/dL was reported as 4.9 mg/kg/min — this type of measurement is used in a controlled research setting to gauge how strongly insulin is acting in the body. The trial also looked at how the skin reacted to the patch; however, no numerical results for that skin assessment were included in the data submitted to ClinicalTrials.gov, so those figures are not available here. It is worth noting that this was a very small study with only 9 participants, and the data as reported describes measurements taken under specific research conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00509925 · results posted 4 August 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people with diabetes — 12 in one group and 11 in the other. It used a "crossover" design, meaning participants took one insulin type first and then switched to the other, so everyone tried both insulin detemir and insulin NPH (a different type of insulin). The main thing the trial was measuring was total daily energy expenditure — in other words, how many calories per day a person's body was burning — using two different methods: a special water-labelling technique (called the double-labelled water method) and a food diary. The trial also looked at several components that make up daily calorie burning, such as calories burned at rest, after eating, and during physical activity. The reported data shows that when measured using the double-labelled water method, people on insulin detemir burned an average of about 2,942 calories per day, compared with about 3,007 calories per day on insulin NPH. When estimated using the food diary method, the figures were approximately 2,018 calories per day on insulin detemir and 2,181 calories per day on insulin NPH. For the breakdown components, resting energy use was reported as roughly 1,933 calories per day (detemir) versus 2,035 (NPH); energy used after eating was about 73 calories per day (detemir) versus 74 (NPH); energy from physical activity was approximately 589 (detemir) versus 543 (NPH); and a measure of lower-intensity everyday movement came in at around 1,164 (detemir) versus 1,170 (NPH). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00607087 · results posted 30 July 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 288 participants across three groups (99, 95, and 94 people respectively), with 252 completing the full study. It was a crossover trial, meaning each participant used all three types of fast-acting insulin — insulin glulisine, insulin aspart, and insulin lispro — through an insulin pump, one at a time across three separate periods. The trial was measuring how often participants experienced either a very high, unexplained blood sugar reading (above 16.7 mmol/L with no obvious cause) or a blockage in their insulin pump's infusion set (the tubing and needle used to deliver insulin under the skin). The reported data shows that, for the main outcome, 68.4% of participants had at least one unexplained high blood sugar or pump blockage while using insulin glulisine, compared with 62.1% during the insulin aspart period and 61.3% during the insulin lispro period. For the secondary outcomes, the reported monthly rate of these combined events was 2.02 per person per month with insulin glulisine, 1.32 with insulin aspart, and 1.54 with insulin lispro. Looking at pump blockages alone, 32.8% of participants experienced at least one while using insulin glulisine, versus 27.0% for both insulin aspart and insulin lispro. The monthly rate of blockages alone was reported as 0.41 (glulisine), 0.28 (aspart), and 0.31 (lispro) events per person per month. For unexplained high blood sugars on their own, the reported percentages were 61.3%, 55.9%, and 56.3% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00143247 · results posted 9 November 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 173 people who used inhaled insulin (brand name Exubera). Only 17 participants completed the study, while 156 did not finish. The trial was primarily tracking changes in lung function over time — specifically a breathing measurement called FEV1, which measures how much air a person can forcefully breathe out in one second (measured in litres). Secondary measurements included changes in blood sugar control (via a test called HbA1c, which reflects average blood sugar over a few months), the rate of low blood sugar episodes (hypoglycaemia), and levels of insulin antibodies (proteins the body can produce in response to insulin). The reported data shows that the primary outcome — lung function — showed a progressive decline over the course of treatment. At the earliest measurement point, participants' FEV1 had decreased by an average of 0.077 litres compared to their starting point, and this figure grew steadily, reaching a reported decrease of 0.344 litres at the latest measurement point. For blood sugar control, the reported data shows reductions in HbA1c ranging from around −0.99% to −0.48% across the different time points measured. For low blood sugar episodes, the reported rate ranged from about 1.36 to 2.38 events per person per month across treatment intervals. Severe low blood sugar events ranged from approximately 0.18 to 2.76 per 100 person-months. Insulin antibody levels were also reported across time points for both Type 1 and Type 2 diabetes subgroups, with no further breakdown of what those levels mean provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00527397 · results posted 5 October 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 adults with either Type 1 or Type 2 diabetes mellitus. The trial was measuring how participants responded to inhaled insulin over up to 26 weeks, looking at things like blood sugar control, insulin dosing, low blood sugar episodes (called hypoglycaemia, meaning blood sugar dropping too low), and lung function. The reported data shows that none of the 24 participants were recorded as having formally "completed" the study under the trial's own definitions, with all 24 listed as "not completed." The reported data shows several measurements across three participant groups — those with Type 1 diabetes, those with Type 2 diabetes who were already using insulin, and those with Type 2 diabetes not using insulin. A blood sugar marker called HbA1c (a percentage that reflects average blood sugar over roughly three months) was reported to have changed from the starting point by figures ranging from around −0.22% to −0.93% depending on the group and time point, with the Type 2 group not using insulin showing the larger reductions. Fasting blood sugar changes varied considerably across groups, with the Type 1 group showing increases from baseline at some time points while the Type 2 groups showed smaller changes. Low blood sugar events were reported most frequently in the Type 1 and insulin-using Type 2 groups (up to 3.5 events per person per month), and much less often in the Type 2 group not using insulin (as low as 0.1 events per person per month). Lung function measurements (how much air a person can breathe out) showed small changes from baseline, mostly slight decreases, with values ranging from approximately −0.105 litres to +0.065 litres across the different time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00487240 · results posted 25 September 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 387 people in total — 195 in the Insulin Lispro Protamine Suspension group and 192 in the Detemir (a long-acting insulin) group. The trial was comparing two types of basal insulin to see how they affected blood sugar control in people with diabetes, primarily by measuring changes in a blood test called HbA1c (a measure of average blood sugar levels over roughly three months, expressed as a percentage). Around 164 to 166 people in each group completed the trial, with 31 and 26 participants respectively not completing it. The reported data shows that at the start of the trial, average HbA1c was 8.88% in the Insulin Lispro Protamine Suspension group and 8.68% in the Detemir group. By the end of the trial, the reported average change from the starting point was a decrease of 0.69 percentage points in the Insulin Lispro Protamine Suspension group and 0.59 percentage points in the Detemir group. Regarding a commonly used blood sugar target, the reported data shows that approximately 18.5% of the Insulin Lispro Protamine Suspension group and 18.7% of the Detemir group reached an HbA1c at or below 7.0% by the end of the trial. The trial also tracked self-reported low blood sugar episodes (hypoglycaemia); the total number of nocturnal (overnight) episodes reported across the whole trial was 134 in the Insulin Lispro Protamine Suspension group and 135 in the Detemir group, while non-nocturnal (daytime) episodes totalled 173 in each group. Severe episodes were reported as 69 versus 55 respectively over the full trial period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT00356421 · results posted 11 August 2009

According to the results reported on ClinicalTrials.gov, this trial (NCT00356421) enrolled 58 people in total — 38 assigned to inhaled insulin (Exubera®) and 20 assigned to an injected insulin (Insulin Lispro). The study was set up to compare the two treatments by looking at changes in a blood sugar marker called HbA1c (a measure of average blood sugar levels over roughly three months), as well as several other blood sugar-related measurements. However, the trial was stopped early after Pfizer decided in October 2007 to hand back the worldwide rights to Exubera® to the company from which it had licensed the technology. Of the 58 people who started, only 9 completed the trial — 6 in the Exubera® group and 3 in the Insulin Lispro group. The reported data shows that, because the trial was ended early and did not enrol enough participants to run a meaningful analysis, no outcome figures were recorded or published for any of the planned measurements. This applies to the primary outcome (change in HbA1c levels) as well as all of the secondary outcomes, which included things like the proportion of participants reaching certain blood sugar targets and changes in fasting blood glucose readings. In other words, the data was not reported for any of these measures — not because the results were withheld, but because the study did not reach the point where results could be meaningfully summarised. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00229658 · results posted 24 June 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 766 people with Type 1 diabetes and 531 people with Type 2 diabetes, giving a total of 1,297 participants. Of those, 541 with Type 1 diabetes and 364 with Type 2 diabetes completed the study. The trial was measuring how often serious low blood sugar episodes (called "severe hypoglycaemia") occurred in people using a medicine called pramlintide. Severe hypoglycaemia was defined as a low blood sugar episode serious enough that the person needed help from someone else, or needed a glucagon injection, a glucose drip, or other medical assistance. The trial tracked these episodes across two time periods: an early "adjustment period" covering the first three months of treatment, and a later "steady state period" covering months three to six. The reported data shows that during the first three months, 4.8% of Type 1 diabetes participants and 2.8% of Type 2 diabetes participants experienced at least one severe low blood sugar episode. Expressed as a rate over a full year, this was approximately 0.33 episodes per person per year for Type 1, and 0.19 for Type 2. During the later three-to-six month period, the reported incidence dropped to 1.8% for Type 1 and 0.3% for Type 2, with yearly rates of approximately 0.08 and 0.02 episodes per person per year respectively. The reported data also shows a smaller subset of episodes serious enough to require medical assistance (such as hospitalisation or emergency care): during the first three months, this occurred in 1.8% of Type 1 participants and 0.4% of Type 2 participants, at yearly rates of approximately 0.10 and 0.02 episodes per person per year respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT00922194 · results posted 17 June 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 102 adults who were overweight and had type 2 diabetes. All 102 participants completed both stages of the study. The trial was measuring changes in a range of body measurements and fasting blood glucose (a measure of blood sugar after not eating) over at least 12 months of taking metformin at the highest dose each person could tolerate. The reported data shows the following average changes from the start of the study to the 12-month-or-more mark: participants' weight decreased by an average of 8.37 kilograms; their BMI (a number calculated from height and weight) decreased by an average of 3.28 units; waist circumference decreased by an average of 7.41 centimetres; the ratio of waist to hip measurement decreased by an average of 0.014; and the ratio of waist to height decreased by an average of 4.61 units. Fasting blood glucose levels decreased by an average of 2.97 mmol/L (millimoles per litre, the standard Australian unit for measuring blood sugar). These figures represent group averages — individual results are not reported in the data. No variability figures (such as ranges or standard deviations) were included in the submitted data. It is worth noting that this trial had only one group of participants, meaning there was no comparison group (for example, people not taking metformin), so the reported changes cannot be directly attributed to the medication alone based on this data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00420095 · results posted 5 June 2009

According to the results reported on ClinicalTrials.gov, this trial involved 117 people with diabetes (57 in one group and 60 in the other). It was a crossover study, meaning participants tried both insulin treatments — Human Insulin Mix 30/70 and Insulin Lispro Low Mix — one after the other, each for 12 weeks. The main thing being measured was a blood test called HbA1c (glycosylated haemoglobin), which gives an indication of average blood sugar levels over the previous three months. Most participants completed the study — 54 out of 57 in one group and 59 out of 60 in the other. The reported data shows that after 12 weeks, the average HbA1c reading was 7.91% for those on Human Insulin Mix 30/70 and 7.96% for those on Insulin Lispro Low Mix. Both groups showed a reduction in HbA1c from their starting point — a drop of 0.68 percentage points for Human Insulin Mix 30/70 and 0.63 percentage points for Insulin Lispro Low Mix. Fasting blood glucose (blood sugar measured after at least 8 hours without eating) also showed a reduction from baseline in both groups: 1.04 millimoles per litre for Human Insulin Mix 30/70 and 1.18 millimoles per litre for Insulin Lispro Low Mix. The reported data also shows that total daily insulin dose actually increased (rather than decreased) from baseline in both groups — noted as a change of −4.72 and −4.56 units respectively, where a negative number here means the endpoint dose was higher than the starting dose. The number of participants who reached an HbA1c target of 7% or below was 26 (Human Insulin Mix 30/70) and 30 (Insulin Lispro Low Mix); for the stricter target of 6.5% or below, it was 11 and 14 participants respectively. The reported data also shows that no participants in either group had laboratory test results (blood, urine, or other chemistry tests) that were recorded as significantly different from their baseline values after 12 weeks of either treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00479258 · results posted 3 November 2008

According to the results reported on ClinicalTrials.gov, this trial (NCT00479258) was set up to compare two ways of delivering insulin to people with diabetes: an inhaled insulin called Exubera, and the participant's usual injected (subcutaneous) insulin. The study planned to run for 12 months and was designed to look at lung health (pulmonary safety) and blood sugar control, as well as several measures of lung function over time and participant treatment preferences. The reported data shows that no participants were actually enrolled or dosed in either group — the records show zero participants started, completed, or left the study early. Because no one received any treatment, no data was collected for any of the outcome measures, whether primary or secondary. The trial's primary question about lung safety and blood sugar control, along with all the planned lung function measurements and preference questions, was therefore left unanswered. The reason for this was not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.