Reported trial results for Type 2 Diabetes
Every Type 2 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.
234 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
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NCT06340854 · results posted 2 July 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 206 people in each of two groups — one group received a weekly insulin called insulin icodec, and the other received a daily insulin called insulin glargine. 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. Secondary measurements included how much time participants spent with their blood sugar in a healthy target range, their satisfaction with their diabetes treatment, and the number of episodes where blood sugar dropped too low (known as hypoglycaemia). The reported data shows that, on average, HbA1c fell by 0.84 percentage points in the icodec group and by 0.58 percentage points in the glargine group over the 26 weeks. For time spent with blood sugar in the target range, the icodec group showed an increase of about 19.94 percentage points of time, compared with 11.04 percentage points for the glargine group. Treatment satisfaction scores (measured on a scale of 0 to 36, where higher means more satisfied) increased by 3.94 points in the icodec group and 2.20 points in the glargine group. Regarding low blood sugar episodes, the reported data shows 2 severe episodes in the icodec group and 1 in the glargine group. For the less severe but still significant low blood sugar episodes (blood sugar below 3.0 mmol/L), 53 were recorded in the icodec group and 70 in the glargine group. When these two categories were combined, there were 55 such episodes in the icodec group and 71 in the glargine 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 ↗ · Linked publication on PubMed ↗
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NCT07465926 · results posted 22 June 2026
According to the results reported on ClinicalTrials.gov, this trial involved a very large number of people — over 278,000 in one group (those whose base diabetes medicine was a GLP-1 RA, a type of injectable or oral diabetes drug) and nearly 173,000 in another group (those whose base medicine was an SGLT2 inhibitor, another type of diabetes tablet). All participants were adults living with obesity, type 2 diabetes, and a combination of heart, kidney, and metabolic health conditions. The trial was an observational study that looked back at real-world health records to compare what happened to people who took different combinations of diabetes medicines over up to 36 months (three years). No participants were recorded as dropping out. The reported data shows the number of people who died from any cause within three years across four different head-to-head comparisons. In the first comparison, 291 deaths were recorded among people taking a GLP-1 RA plus an SGLT2 inhibitor add-on, compared with 444 deaths among those taking a GLP-1 RA plus an older add-on medicine (a DPP-4 inhibitor or sulfonylurea). In the second comparison, 674 deaths occurred in the GLP-1 RA plus SGLT2 inhibitor add-on group versus 877 in those taking a GLP-1 RA alone with no early add-on. For the third comparison, 352 deaths were recorded in those on an SGLT2 inhibitor plus a GLP-1 RA add-on, against 562 in those on an SGLT2 inhibitor plus an older add-on medicine. In the fourth comparison, 593 deaths occurred in the SGLT2 inhibitor plus GLP-1 RA add-on group versus 770 in those on an SGLT2 inhibitor alone. The reported data also includes secondary outcomes looking at major adverse cardiovascular events (serious heart-related complications such as heart attack or stroke). In the first comparison, 490 such events were recorded in the GLP-1 RA plus SGLT2 inhibitor add-on group versus 553 in the older add-on group. In the second comparison, 1,137 events occurred in the GLP-1 RA plus SGLT2 inhibitor add-on group versus 1,193 in the GLP-1 RA alone group. Results for this secondary outcome across the third and fourth comparisons were not 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05046886 · results posted 18 June 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 161 people across three groups: 59 in a "Usual Care Control" group (who received standard care), 61 in a "Standardised" group, and 41 in a "Personalised" group. The trial was measuring how much a person's blood sugar levels fluctuated up and down over time, using a small sensor worn on the upper arm that recorded readings every 15 minutes for up to two weeks. It also measured HbA1c — a blood test that reflects average blood sugar levels over the previous few months. Most participants finished the study: 52, 56, and 38 people completed it in each group respectively. The reported data shows that blood sugar fluctuation (called Mean Amplitude of Glycemic Excursion, or MAGE — essentially a score of how much blood sugar rose and fell) was measured at two time points. At the first time point, the reported scores were approximately 75.1 mg/dL for the Usual Care group, 76.6 mg/dL for the Standardised group, and 75.3 mg/dL for the Personalised group. At the second time point, the reported scores were approximately 80.6 mg/dL, 75.5 mg/dL, and 75.9 mg/dL respectively. For the HbA1c blood test, the reported figures at the first time point were roughly 6.8%, 6.75%, and 6.9% across the three groups, and at the second time point approximately 6.8%, 6.7%, and 6.9%. The trial notes that HbA1c levels of 5.7–6.4% are generally associated with prediabetes, and 6.5% or above with a diabetes diagnosis. 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 ↗
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NCT04226027 · results posted 13 May 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04226027) enrolled 300 people with type 2 diabetes — 148 in a group using something called "T2.Coach" and 152 in a control group (a comparison group that did not use T2.Coach). By the end of the study, 130 people in the T2.Coach group and 136 in the control group had completed it. The trial was primarily measuring a blood marker called HbA1c — a percentage that reflects average blood sugar levels over roughly three months — at 12 months, and also tracked three secondary measures: self-care habits, confidence in managing diabetes, and emotional distress related to diabetes. The reported data shows that at the start of the study, average HbA1c was 9.84% in the T2.Coach group and 10.17% in the control group. At 6 months, these figures were 8.91% and 9.23% respectively, and at 12 months they were 8.72% and 9.32%. For the self-care score (rated 1–100, higher meaning better self-care), the T2.Coach group went from 65.54 at the start to 73.81 at 12 months, while the control group went from 68.86 to 74.16. For confidence in self-managing diabetes (rated 1–10, higher meaning more confident), the T2.Coach group moved from 5.73 to 6.27 over 12 months, and the control group from 5.91 to 6.05. For emotional distress related to diabetes (rated 0–80, where a higher score means more distress), the T2.Coach group went from 29.62 at the start to 26.43 at 12 months, while the control group went from 31.16 to 25.20. The reported data shows changes across both groups over the course of the trial in all four measures, but this summary simply describes the numbers as submitted — it does not draw conclusions about why those changes occurred or what caused 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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NCT05971940 · results posted 22 April 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05971940) enrolled 559 adults across four groups to study the drug orforglipron at three different doses (3 mg, 12 mg, and 36 mg daily) compared to a placebo (an inactive dummy treatment). The trial's main focus was measuring changes in a blood sugar marker called HbA1c — a measure of average blood sugar levels over roughly three months — in people with type 2 diabetes. The vast majority of participants who started the trial completed it: 131 of 138 in the placebo group, 134 of 143 in the 3 mg group, 125 of 137 in the 12 mg group, and 136 of 141 in the 36 mg group. The reported data shows that HbA1c levels fell in all four groups by the end of the study. The placebo group's HbA1c dropped by an average of 0.15 percentage points, while the three orforglipron groups saw larger average drops: 1.26 percentage points (3 mg), 1.59 percentage points (12 mg), and 1.45 percentage points (36 mg). For a secondary measure — the proportion of participants whose HbA1c reached below 7.0% (a commonly used target in diabetes care) — the reported figures were 37% for placebo, 78% for 3 mg, 81% for 12 mg, and 79% for 36 mg. For an even lower target of 6.5% or below, the reported figures were 19% (placebo), 66% (3 mg), 69% (12 mg), and 69% (36 mg). The reported data also shows changes in fasting blood sugar (a single blood sugar reading taken after not eating), with average drops of 1.1 mg/dL for placebo versus 30.6, 37.4, and 37.8 mg/dL for the three orforglipron doses respectively. Body weight also changed: the placebo group lost an average of 1.3 kg (about 1.6%), while the orforglipron groups lost an average of 4.4 kg (4.7%), 5.5 kg (6.1%), and 7.3 kg (7.9%) for the 3 mg, 12 mg, and 36 mg doses 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 ↗
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NCT05238142 · results posted 16 April 2026
According to the results reported on ClinicalTrials.gov, this trial involved people with diabetes who used a continuous glucose monitoring (CGM) system — a wearable device that tracks blood sugar levels throughout the day. The trial was run in two phases. In Phase 1, 95 people started the main study period, with 89 completing it, and 66 going on to a continuation period. In Phase 2, 66 participants from Phase 1 continued alongside 236 newly enrolled participants. The trial measured two main things: "Time in Range" (TIR) — meaning the proportion of time a person's blood sugar stayed within a target range of 70–180 mg/dL — and changes in HbA1c, which is a blood test that reflects average blood sugar levels over roughly three months. The reported data shows that in Phase 1, participants spent an average of 80.9% of their time with blood sugar in the target range, and their HbA1c level changed by an average of −0.71 percentage points from the start to the end of the study period. In Phase 2, the reported Time in Range across all participants was 85.4%. For HbA1c in Phase 2, results were reported separately for two groups: those who had transitioned from Phase 1 showed an average change of −0.26 percentage points, while those who were newly enrolled showed an average change of −0.70 percentage points. The reported data shows the same Time in Range figure of 80.9% was also listed as a secondary outcome measure for Phase 1, tested under a different statistical standard (called a "superiority test" rather than a "non-inferiority test" — these are simply different ways of comparing results). No other secondary outcome figures 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT06206525 · results posted 15 April 2026
According to the results reported on ClinicalTrials.gov, this trial involved 178 people in hospital who had their blood sugar levels monitored and managed with insulin. There were two groups: 38 people whose initial insulin dose was guided by a dosing calculator tool, and 140 people in an observational group whose care was managed without the calculator. The trial was measuring things like dangerously low blood sugar (below 54 mg/dL), dangerously high blood sugar (300 mg/dL or above), and average blood sugar levels in the first 24 hours after admission. The reported data shows that, for the primary outcome — a very low blood sugar reading below 54 mg/dL — 0 out of 38 people in the calculator group experienced this, compared to 1 out of 140 in the observational group. For the secondary outcomes, the average blood sugar reading over the first 24 hours was reported as 184.5 mg/dL in the calculator group and 204.0 mg/dL in the observational group. The reported data also shows that 1 out of 38 people in the calculator group had a very high blood sugar reading of 300 mg/dL or above, compared to 42 out of 140 in the observational group. For blood sugar readings below 70 mg/dL (a broader low blood sugar threshold), 0 people in the calculator group and 2 people in the observational group were reported to have reached this 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05727579 · results posted 15 April 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people in total, spread across eight groups who each received the four different treatment combinations in a different order. The study was looking at whether the amount of salt a person eats changes how a diabetes medication called ertugliflozin affects blood pressure over a 24-hour period. Participants were overweight or obese adults with type 2 diabetes, and they were tested under two diet conditions — a moderate-salt diet (in line with World Health Organization recommendations) and a high-salt diet — while taking either ertugliflozin or a placebo (a dummy tablet with no active ingredient). Of the 41 who started, 34 completed the trial; the data does not report reasons for the seven who did not finish. The reported data shows the following average 24-hour blood pressure readings (measured in mmHg, a standard unit for blood pressure, where the first number is the pressure when the heart beats and the second is the pressure when the heart rests): on a moderate-salt diet with placebo, readings were 125/77; on a moderate-salt diet with ertugliflozin, readings were 121/75; on a high-salt diet with placebo, readings were 138/84; and on a high-salt diet with ertugliflozin, readings were 133/82. No further breakdown or statistical analysis figures were included in the data submitted to ClinicalTrials.gov. Secondary outcome results were not 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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NCT04725890 · results posted 22 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04725890) enrolled 65 people with type 2 diabetes who received a procedure called Pulsed Electric Field (PEF) treatment using a device called Endogenex. Participants were split into two groups: those not using insulin and those already on insulin. The trial was primarily looking at whether the procedure caused any serious unexpected harms related to the device or the procedure itself within 12 weeks. It also tracked blood sugar control (using a measure called HbA1c — a percentage that reflects average blood sugar over roughly three months), fasting blood glucose levels (a snapshot of blood sugar after not eating), and body weight over time. Of the 65 people who started, 59 completed the trial and 6 did not. The reported data shows that for the primary outcome — serious adverse events linked to the device or procedure — zero participants in the non-insulin group and one participant in the insulin group experienced such an event. For blood sugar control (HbA1c), the non-insulin group started at a reported average of 8.8% and the readings across follow-up visits were reported as 7.7%, 7.8%, and 7.7%. The insulin group started at 8.5% and follow-up readings were reported as 7.9%, 8.1%, and 7.6%. For fasting blood glucose, the non-insulin group began at an average of 10.1 mmol/L, with later visits showing 8.4, 7.6, and 7.9 mmol/L; the insulin group began at 8.6 mmol/L, with later visits showing 8.3, 8.8, and 7.5 mmol/L. Average body weight in the non-insulin group started at 94 kg and was reported as 90, 86, and 89 kg at follow-up visits; the insulin group started at 80 kg with follow-up readings of 79, 77, and 73 kg. The data does not specify which visit each time point corresponds to beyond the order listed. The reported data also shows that the procedure was considered successfully completed in 51 participants in the non-insulin group and 14 in the insulin group, with average procedure times of approximately 74 minutes and 103 minutes respectively. It is important to note that this was a single-group study with no comparison group, so all figures reflect only the people who received the 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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NCT05394844 · results posted 1 December 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 120 people with diabetes — 61 in a group that used a continuous glucose monitor (CGM, a small wearable device that tracks blood sugar levels throughout the day) alongside diabetes education, and 59 in a group that received diabetes education alone. By the end of the study, 45 people in the CGM-plus-education group and 40 in the education-only group completed the trial. The trial was measuring several things, including blood sugar control, average glucose levels, body weight, blood pressure, and physical activity. The reported data shows that, for the main measure — a blood test called HbA1c, which reflects average blood sugar levels over roughly three months — the CGM-plus-education group saw a reported change of −2.3% (a reduction), while the education-only group saw a reported change of −1.5% (also a reduction). For the secondary measures, average glucose readings at 12 weeks were reported as 208.4 mg/dL in the CGM group and 239.6 mg/dL in the education-only group. The proportion of time participants spent with blood sugar in a target range was reported as 13.2% for the CGM group and 6.2% for the education-only group. Body mass index (a measure of body weight relative to height) changed by −1% in the CGM group and −2.4% in the education-only group. Systolic blood pressure (the top number in a blood pressure reading) changed by −2.5 mmHg in the CGM group and −0.3 mmHg in the education-only group. Reported days of vigorous physical activity increased by 1 day in the CGM group and 0.14 days in the education-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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04953442 · results posted 15 September 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04953442) involved 43 participants in total — 21 in a "wait list control" group (who waited before receiving anything) and 22 in an "intervention" group (who received the program being studied). The trial appeared to be a feasibility study, meaning its main goal was not to test whether a treatment worked, but rather to check whether the study itself could be run successfully — for example, whether enough people could be recruited, whether the technology involved caused problems, and whether participants were satisfied with taking part. All 22 intervention participants completed the study, while 3 of the 21 wait-list participants did not complete it. The reported data shows that for the three primary measures: 43 participants were recruited in total (21 and 22 across the two groups); 16 technical issues were recorded among intervention participants, compared with 0 in the wait-list group; and 19 out of 22 intervention participants reported being satisfied with their participation, while the wait-list group recorded 0 for this measure (suggesting this question may not have applied to them). For one of the additional pre-specified measures — average minutes of sleep per night, tracked using a wrist or body sensor over seven days — the intervention group averaged approximately 471 minutes per night and the wait-list control group averaged approximately 503 minutes per night. The reported data shows that results for average minutes of physical activity and Body Mass Index were not 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03133156 · results posted 14 August 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 93 participants across four groups: people who were healthy and lean doing moderate-intensity exercise (35 people), people who were healthy but overweight or obese doing moderate-intensity exercise (35 people), people who were overweight or obese and had type 2 diabetes doing moderate-intensity exercise (11 people), and people who were healthy and lean doing high-intensity exercise (12 people). The trial was measuring how body fat and body weight changed in these different groups after a period of exercise training. Not everyone who started finished — across all groups, a total of 74 participants completed the study. The reported data shows the following average measurements before and after the exercise program. For **body fat percentage**, the moderate-intensity healthy lean group went from 25.45% to 25.38%; the moderate-intensity overweight/obese group went from 34.12% to 33.90%; the overweight/obese type 2 diabetes group went from 38.06% to 37.20%; and the high-intensity healthy lean group went from 27.05% to 25.32%. For **body fat in kilograms**, the reported figures moved from 17.83 kg to 17.69 kg, 29.96 kg to 29.61 kg, 31.47 kg to 30.61 kg, and 19.76 kg to 18.11 kg for those same four groups respectively. For **body weight in kilograms**, the reported figures moved from 70.55 kg to 70.40 kg, 88.22 kg to 87.59 kg, 82.40 kg to 81.90 kg, and 73.27 kg to 71.81 kg 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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NCT04880850 · results posted 2 July 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04880850) enrolled 582 people in total — 291 in a group receiving a once-weekly insulin called insulin icodec, and 291 in a group receiving a once-daily insulin called insulin glargine. The main thing the trial was measuring was a blood test called HbA1c (glycated haemoglobin), which gives an average picture of blood sugar levels over roughly three months. Researchers tracked this and several other blood sugar-related measures over 26 weeks (about six months). Most participants completed the trial — 275 in the icodec group and 273 in the glargine group. The reported data shows that, on average, HbA1c levels fell by 1.16 percentage points in the insulin icodec group and by 1.18 percentage points in the insulin glargine group over the 26 weeks. For fasting plasma glucose (a blood sugar reading taken after not eating overnight), the reported average reduction was 1.75 mmol/L in the icodec group and 1.61 mmol/L in the glargine group. A continuous glucose monitor was also used to track what proportion of time participants spent with their blood sugar within a target range (3.9–10.0 mmol/L); the reported figure was about 66.9% of the time for the icodec group and 66.4% for the glargine group. Regarding low blood sugar episodes (called hypoglycaemia), the trial counted episodes at two levels of seriousness. For the most serious type — where someone needed outside help to recover — 7 episodes were recorded in the icodec group and 3 in the glargine group. For the next level down (blood sugar dropping below 3.0 mmol/L, which is considered clinically significant), 937 episodes were recorded in the icodec group and 935 in the glargine group. When both categories were combined, the totals were 944 episodes for icodec and 938 for 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05785832 · results posted 3 June 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 319 people with diabetes across two groups: 215 in the "Control-IQ+ AID" group (which used an automated insulin delivery system) and 104 in the "CGM Arm" (which used a continuous glucose monitor without the automated delivery component). The trial was primarily measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly three months, expressed as a percentage. Of those who started, 211 and 102 participants respectively completed the study. The reported data shows that, for the primary measure of HbA1c, the Control-IQ+ AID group started at an average of 8.2% and ended at 7.3%, a change of −0.9 percentage points. The CGM Arm started at 8.1% and ended at 7.7%, a change of −0.3 percentage points. For the secondary measures, the reported data shows the Control-IQ+ AID group spent an average of 48% of time with blood sugar in the target range (70–180 mg/dL) at the start, rising to 64% — a change of +16 percentage points — while the CGM Arm moved from 51% to 52%, a change of +1 percentage point. Average blood sugar levels in the Control-IQ+ AID group fell from 194 to 170 mg/dL (a change of −24 mg/dL), compared with a change of −1 mg/dL in the CGM Arm. The proportion of time spent above 180 mg/dL fell by 16 percentage points in the Control-IQ+ AID group and by 1 percentage point in the CGM Arm. Time spent above 250 mg/dL fell by 9.7 percentage points in the Control-IQ+ AID group, while the CGM Arm showed a small increase of 1.0 percentage point. Episodes of prolonged high blood sugar (defined as blood sugar above 300 mg/dL for more than 90 minutes in a two-hour window) fell from 1.7 to 0.9 events per week in the Control-IQ+ AID group, while the CGM Arm remained at 1.6 events per week, a change of 0.0. 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 ↗
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NCT03895996 · results posted 5 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03895996) enrolled 25 people in total — 16 received the investigational treatment AVT001, and 9 received a matched placebo (an inactive dummy treatment). All participants went through a procedure called leukapheresis (where blood cells are collected) and received their assigned doses. The trial was primarily measuring safety and tolerability — that is, tracking any unwanted medical events that occurred during or shortly after treatment, as well as monitoring certain blood markers. The reported data shows that, when it came to treatment-emergent adverse events (unexpected medical events that arose during the study period), 9 out of 16 participants in the AVT001 group experienced at least one such event, compared with 6 out of 9 in the placebo group. The reported data also shows that no participants in either group experienced a reaction at the intravenous (drip) site where the treatment was given. For the blood markers monitored, the AVT001 group showed an average change from their starting level of +1.93 units for creatinine (a kidney-related marker), −1.9 units for one liver enzyme (aspartate aminotransferase), −0.1 units for another liver enzyme (alanine aminotransferase), and −0.11 units for total bilirubin (a liver-related marker). The placebo group showed changes of +0.49, +2.2, +1.1, and 0.00 units for those same markers, 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 ↗
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NCT02010242 · results posted 28 February 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT02010242) enrolled 136 adults in total — 68 received an investigational medicine called GKT137831 and 68 received a placebo (a dummy treatment with no active ingredient). The trial was primarily looking at a measure called UACR (urine albumin-to-creatinine ratio), which reflects how much of a protein called albumin is leaking into the urine — a marker used to monitor kidney health in people with diabetes. The treatment period ran for 12 weeks, with kidney-related measurements taken at weeks 8, 10, and 12. The reported data shows that, for the primary measure (UACR), the GKT137831 group had an average end-of-treatment UACR of around 758 mg/g, compared with a starting point of around 706 mg/g. The placebo group had an average end-of-treatment UACR of around 705 mg/g, compared with a starting point of around 696 mg/g. For a secondary measure of kidney function called eGFR (a score that reflects how well the kidneys filter the blood), both groups showed small changes from their starting values across the study visits, ranging from roughly −0.1 to −1.9 units in each group at different time points. For 24-hour albumin leakage into urine, the GKT137831 group showed a reported change of approximately +390 mg compared with approximately −56 mg in the placebo group. Changes in blood sugar–related measures (HbA1c and insulin resistance scores) were also reported and were small 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT06473662 · results posted 6 February 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT06473662) enrolled 153 participants across three groups, each receiving a different dose of the study treatment: 51 people in the 75 IU group, 50 in the 150 IU group, and 52 in the 300 IU group. The trial was measuring changes in blood sugar control and blood fats compared to where each participant started (their "baseline"). Not everyone completed the study — 33, 29, and 38 participants finished in each group respectively, meaning a notable number did not complete the trial in all three groups. The reported data shows that the main thing being measured was HbA1c — a standard blood test that reflects average blood sugar levels over roughly three months, expressed as a percentage. All three groups showed a reported decrease from their starting point: the 75 IU group fell by 0.20 percentage points, the 150 IU group by 0.53 percentage points, and the 300 IU group by 0.31 percentage points. For fasting blood sugar (measured first thing in the morning before eating), the reported changes were −14.8, −18.8, and −2.7 mg/dL respectively. For blood sugar measured after meals, the reported changes were −17.4, −21.0, and −31.0 mg/dL across the three groups. The trial also measured triglycerides (a type of fat in the blood), reporting changes of −7.06, −22.13, and +20.56 mg/dL — meaning the 300 IU group showed a reported increase in triglycerides from their starting level, while the other two groups showed reported decreases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04251156 · results posted 29 November 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04251156) enrolled 375 adults in total — 249 received semaglutide 2.4 mg (a weekly injection) and 126 received a placebo (an inactive injection). The trial ran for up to 51 weeks and was primarily measuring changes in body weight over 44 weeks. The reported data shows that, on average, participants in the semaglutide group had a body weight change of −12.5% (roughly −11.9 kg) from their starting weight by week 44, compared with −3.6% (roughly −3.4 kg) in the placebo group. When looking at how many individuals reached certain weight-loss thresholds, the reported figures show: 203 out of 249 people in the semaglutide group lost 5% or more of their body weight, compared with 36 out of 126 in the placebo group; 151 vs 12 participants lost 10% or more; and 82 vs 7 participants lost 15% or more. The reported data also shows that waist circumference changed by an average of −11.1 cm in the semaglutide group and −3.8 cm in the placebo group by week 44. It is important to note that these figures describe what was measured and recorded in this specific group of trial participants — they do not tell us whether the treatment is suitable or appropriate for any particular individual. 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 ↗
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NCT02637622 · results posted 29 November 2024
According to the results reported on ClinicalTrials.gov, this trial involved 1,103 participants in total — 551 in one group and 552 in another. All participants completed the study with no drop-outs recorded. Rather than testing a medicine directly, this was a survey-based study designed to understand what features of a medication matter most to patients when making choices. The two groups were asked to evaluate medication attributes using two different survey methods: one called "Best-Worst Scaling" and another called a "Discrete Choice Experiment." Both methods are ways of asking people to compare options and indicate what they value most. The reported data shows that both survey methods measured six medication attributes, each with three levels. For each attribute, a score above zero meant that feature was rated more favourably than average, while a score below zero meant it was rated less favourably. In the Best-Worst Scaling group, the attribute levels ranged from a high of 0.983 (most preferred) to a low of −1.267 (least preferred). In the Discrete Choice Experiment group, the range was from 0.395 to −0.623. The study also measured the overall importance participants placed on each attribute, rescaled to a 0–10 range. The reported data shows that in the Best-Worst Scaling group, the most important attribute scored 10 out of 10, while in the Discrete Choice Experiment group, a different attribute scored 10 out of 10 — suggesting the two methods ranked the attributes in a somewhat different order of importance. As a secondary measure, participants were asked how easy or difficult they found the survey questions. The reported data shows that across both groups, the largest number of participants — 248 in the Best-Worst Scaling group and 292 in the Discrete Choice Experiment group — chose a response indicating the questions were relatively straightforward to understand and answer, while smaller numbers at either end reported finding them very difficult or very easy. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03717194 · results posted 20 November 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03717194) enrolled 102 people in total — 51 in an intervention group who received a medication called ertugliflozin, and 51 in a control group. By the end of the 24-week study, 48 people in the intervention group and 46 in the control group had completed the trial. The trial was measuring several aspects of how the heart was functioning, using ultrasound-based assessments of the heart muscle and its pumping activity. The reported data shows the following figures after 24 weeks. For the primary measure — a heart muscle movement score called Left Ventricular Global Longitudinal Strain (a way of assessing how well the heart muscle squeezes) — the ertugliflozin group recorded 16.6% and the control group recorded 16.4%. For the secondary measures: heart muscle mass relative to body size (Left Ventricular Mass Index) was 92.6 g/m² in the ertugliflozin group and 99.1 g/m² in the control group; the heart's pumping fraction (the percentage of blood pushed out with each beat) was 61.3% and 61.5% respectively; a measure of how well the heart relaxes between beats (E/e' ratio) was 10.6 versus 10.4; the size of the heart's upper-left chamber relative to body size (Left Atrial Volume Index) was 35.5 mL/m² versus 35.3 mL/m²; and the volume of blood in the lower-left heart chamber at the end of filling was 82.2 mL in the ertugliflozin group compared with 75.0 mL in the 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05831644 · results posted 12 November 2024
According to the results reported on ClinicalTrials.gov, this trial involved 11 participants in total. It used a "crossover" design, meaning each person tried both the experimental treatment (called C21) and a placebo (an inactive treatment) at different times, with a washout period in between to clear each treatment from the body before switching. The trial was measuring how C21 affected blood vessel function compared to the placebo. Six participants started with C21 first, then switched to placebo, while five started with placebo first, then switched to C21. All 11 participants completed every stage of the trial. The reported data shows two measurements of blood vessel behaviour, both taken using a device called EndoPAT. The first — and main — measurement was the Reactive Hyperemia Index (RHI), which is a score reflecting how well the inner lining of blood vessels responds after brief pressure is applied. A score above 1.67 is considered normal. The reported data shows an average RHI score of 1.787 during C21 treatment and 1.911 during placebo treatment. The trial was designed so that a *lower* RHI score after C21 compared to placebo would be the outcome of interest; the reported numbers show the C21 score was lower than the placebo score. The second measurement was the Augmentation Index (AI), which reflects blood vessel stiffness — where a higher number suggests greater stiffness. The reported data shows an average AI score of approximately 15.9 during C21 treatment and approximately 20.9 during placebo treatment. It is worth noting that this was a very small trial with only 11 participants, and the results as reported here are summary numbers only, without additional context about how meaningful the differences between groups may or may not be. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05486065 · results posted 5 November 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05486065) enrolled 245 participants in total, spread across four groups: three groups received different doses of an injectable medicine called semaglutide (2.0 mg, 8.0 mg, or 16.0 mg), and one group received a placebo (an inactive treatment). The trial ran for 40 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. Changes in body weight and certain medical events were also tracked as secondary measures. The reported data shows that, over the 40 weeks, HbA1c levels fell in all four groups. The 2.0 mg semaglutide group saw an average drop of 1.9 percentage points, the 8.0 mg group dropped 1.8 percentage points, the 16.0 mg group dropped 2.1 percentage points, and the placebo group dropped 1.1 percentage points. For body weight, the reported average changes were: minus 8.9 kg (2.0 mg group), minus 10.1 kg (8.0 mg group), minus 13.1 kg (16.0 mg group), and minus 2.3 kg (placebo group). The reported data also shows the number of medical events that occurred during treatment: 43 events in the 2.0 mg group, 54 in the 8.0 mg group, 55 in the 16.0 mg group, and 37 in the placebo group. Importantly, the number of severe low blood sugar episodes — defined as episodes serious enough to need help from another person to recover — was reported as zero in every 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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NCT05478252 · results posted 9 October 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 388 participants in total — 291 in a group labelled "Semaglutide J" and 97 in a group labelled "Semaglutide B." Both groups were taking a medicine called semaglutide, and the trial appears to have been comparing two versions of it over 28 weeks (about seven months). The trial was primarily measuring changes in a blood sugar marker called HbA1c — a percentage figure that reflects average blood sugar levels over the previous few months — and also tracked body weight and several other measures. The reported data shows that, when it came to the primary measure (HbA1c), the Semaglutide J group had an average reduction of 1.7 percentage points from their starting level, while the Semaglutide B group had an average reduction of 1.6 percentage points. For body weight, the reported data shows an average reduction of 5.0 kg in the Semaglutide J group and 4.6 kg in the Semaglutide B group over the 28 weeks. The trial also counted "treatment-emergent adverse events" — meaning any unwanted medical occurrences that happened during the treatment period — with 156 events recorded in the Semaglutide J group (291 people) and 52 in the Semaglutide B group (97 people). Regarding the body's immune response to the medicine, only 1 participant in the Semaglutide J group and 0 in the Semaglutide B group tested positive for antibodies (proteins the immune system can produce in response to a medicine) against semaglutide. No data was reported for neutralising antibody effects, as the required conditions for that analysis were not met. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04889157 · results posted 1 October 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants in total — 5 received a placebo (an inactive substance) and 15 received the investigational medicine, PF-06882961, taken twice daily. All 20 participants completed both the treatment period and the follow-up period, with no one dropping out. The trial was primarily measuring how the drug moves through the body — specifically, how much of it is absorbed into the bloodstream over time and what peak level it reaches in the blood. The reported data shows that for the main (primary) outcome measures, a single 10 mg dose of PF-06882961 produced an average total drug exposure over 24 hours (a measure called AUC24, which tracks how much drug was present in the blood across that time) of 287.4 ng·hr/mL, and a peak blood concentration (the highest level measured) of 37.37 ng/mL. It is important to note that the sponsor stated the planned analysis for these primary measures was not considered reliable, so these figures should be interpreted with caution. For the secondary outcomes, the reported data shows that among those receiving PF-06882961, 14 out of 15 participants experienced treatment-related unwanted medical events (called adverse events), compared with 5 out of 5 in the placebo group; no serious adverse events were reported in either group. Small numbers of participants in both groups also had changes in vital signs (such as blood pressure or pulse), abnormal heart tracing (ECG) results, or abnormal laboratory test results, with the specific counts varying across the different measurements 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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NCT05404711 · results posted 25 September 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 young participants to explore whether a continuous glucose monitor (CGM) — a small sensor worn on the body that tracks blood sugar levels throughout the day — could be used at home to screen for type 2 diabetes risk. The trial was testing whether this approach was practical and acceptable to participants, and how well a home-based CGM sugar-drink test compared to the standard clinic-based blood sugar test (called an oral glucose tolerance test, or OGTT). The reported data shows that for the main question — whether participants could collect enough CGM data (at least 80% of days with usable readings) — 33 out of the group met this threshold, while 5 did not. For acceptability, meaning whether participants rated their experience as neutral or better on a 1-to-5 scale, the reported data shows 33 participants gave a neutral or higher rating, while 3 did not. Regarding how well the home CGM test compared to the clinic test, the reported figures show that the CGM correctly identified 80% of people whose clinic test flagged a concern (true positives), but only 25% of people whose clinic test did not flag a concern (true negatives). The reported data also shows that when the home CGM test gave a concerning result, it matched the clinic test's concerning result about 18.2% of the time, and when it gave a non-concerning result, it matched the clinic's non-concerning result about 85.7% of the time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04265261 · results posted 25 September 2024
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called vicasinabin in two different daily doses (30 mg and 200 mg) compared to a placebo (a dummy treatment with no active ingredient) in people with diabetic retinopathy — an eye condition linked to diabetes that can threaten vision. A total of 139 people started the trial across the three groups (47 on placebo, 48 on the lower dose, and 44 on the higher dose), and the trial ran for 36 weeks. The main things being measured were whether participants' retinopathy showed meaningful improvement on a standard grading scale, and how many people experienced any unwanted health events during the trial. The reported data shows that, for the main improvement measure — the proportion of people whose retinopathy improved by at least two steps on the grading scale by week 36 — the figures were 7.89% for the placebo group, 9.52% for the 30 mg group, and 5.71% for the 200 mg group. For unwanted health events, 72.3% of placebo participants, 64.6% of the 30 mg group, and 81.4% of the 200 mg group reported at least one such event. Regarding vision changes (measured by a standard eye-chart letter score), the adjusted average change from the start of the trial was a very small gain of 0.12 letters for placebo, and small declines of 0.45 letters and 0.22 letters for the 30 mg and 200 mg groups respectively. For the time-to-event measure — how long before half the group developed a serious vision-threatening complication — this figure was only calculable for the 30 mg group (267 days); the data was not reported for the placebo or 200 mg groups, likely because not enough events occurred in those groups to calculate 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05552859 · results posted 5 September 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 62 people in total — 31 in each group. One group received a long-acting insulin called Gla-300 (insulin glargine 300 units/mL) and the other received a long-acting insulin called IDeg-100 (insulin degludec 100 units/mL). The trial ran for 24 weeks and was primarily measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly three months. It is worth noting that of the 62 people who started the trial, only 2 (one per group) completed it, meaning the vast majority did not finish. The reported data shows that, on average, the HbA1c level in the Gla-300 group fell by 0.4 percentage points from the start to week 24, while the IDeg-100 group's fell by 1.0 percentage point. For fasting blood sugar (a single blood glucose reading taken after not eating), the Gla-300 group's average reading dropped by 36.4 mg/dL and the IDeg-100 group's dropped by 55.5 mg/dL. Regarding the proportion of participants who reached an HbA1c target below 7.0% by week 24, the reported data shows 4 participants in the Gla-300 group and 2 in the IDeg-100 group reached that level. The trial also tracked low blood sugar episodes (called hypoglycaemia — when blood sugar drops to a potentially concerning level). The reported data shows 35.5% of participants in the Gla-300 group and 29.0% in the IDeg-100 group had at least one such recorded episode. Some secondary outcome figures were only partially reported, and the data for the IDeg-100 group's self-measured fasting glucose 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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NCT04285983 · results posted 23 August 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 89 people who all took a once-weekly oral medication called trelagliptin (25 mg). There was no comparison group — everyone received the same treatment. The trial was primarily measuring how many participants experienced adverse drug reactions (ADRs), which are unwanted medical events considered to be linked to the study drug. Of the 89 people who started, 83 completed the study and 6 did not. The reported data shows that out of 89 participants, 6 people experienced one or more adverse drug reactions of any kind. When looking specifically at serious adverse drug reactions — meaning reactions serious enough to be life-threatening, require hospitalisation, or cause lasting harm — the reported data shows that 2 participants experienced these. The trial also tracked two specific types of reactions separately: low blood sugar episodes (hypoglycaemia) and infections. According to the reported data, no participants experienced a serious adverse drug reaction related to low blood sugar, while 1 participant experienced a non-serious adverse drug reaction in that category. For infections, the reported data shows zero participants experienced either a serious or non-serious infection-related adverse drug reaction. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02925676 · results posted 26 July 2024
According to the results reported on ClinicalTrials.gov, this trial looked at a device called the Hyposafe H02, which is designed to detect episodes of low blood sugar (hypoglycaemia). Eight people took part in the study, and seven completed it — one person did not finish. The trial was measuring how well the device picked up low blood sugar episodes compared to traditional finger-prick blood glucose testing, which was used as the reference check. The reported data shows two main things were measured for naturally occurring low blood sugar episodes: "sensitivity" (meaning, out of all confirmed low blood sugar episodes, what percentage did the device actually detect?) and "positive predictive value" (meaning, out of all the times the device sounded an alert, what percentage were confirmed as genuine low blood sugar?). For naturally occurring episodes, the reported sensitivity was 100%, meaning the device flagged every confirmed episode. However, the reported positive predictive value figures were 8% and 2%, meaning the large majority of the device's alerts were not confirmed as actual low blood sugar by the finger-prick test. When looking across all types of low blood sugar episodes combined, the reported data shows an overall sensitivity of 81% and an overall positive predictive value of 11%. For episodes triggered deliberately with insulin (a controlled part of the study), sensitivity was reported at 57%, while the positive predictive value for those episodes was reported at 100%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03371940 · results posted 28 May 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03371940) enrolled 140 adults across four groups: one group received talk therapy (a type called Cognitive Behavioural Therapy, or CBT), one did exercise, one did both CBT and exercise combined, and one received usual care only. All participants had both diabetes and depression. The trial was measuring three main things: changes in blood sugar control (using a test called HbA1c, which reflects average blood sugar over a few months), changes in depression symptoms, and how many participants moved out of a formal diagnosis of major depression. A secondary measure looked at changes in physical fitness using a six-minute walking test. The reported data shows the following changes from the start of the trial to around three months later. For blood sugar (HbA1c, where a lower number is generally considered better): the CBT group's average went up by 0.06 percentage points, the exercise group's went down by 0.03, the combined CBT-plus-exercise group's went down by 0.17, and the usual care group's went up by 0.20. For depression symptoms scored on a questionnaire (where a more negative number means fewer symptoms reported): the CBT group showed an average change of −15.24, the exercise group −14.11, the combined group −18.12, and the usual care group −8.21. Regarding the number of participants who reached full or partial remission from a depression diagnosis: 16 in the CBT group, 21 in the exercise group, 17 in the combined group, and 9 in the usual care group. For the six-minute walking test (reported as change in feet walked): the CBT group changed by −6.16 feet, the exercise group by +65.60 feet, the combined group by +0.74 feet, and the usual care group by +23.68 feet. The reported data does not include information about whether these differences between groups were considered statistically meaningful (i.e., unlikely to be due to chance). 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 ↗
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NCT03199053 · results posted 17 April 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 245 children and young people across three groups: 81 received dapagliflozin, 88 received saxagliptin, and 76 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in a blood marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly three months — after 26 weeks of treatment. The study had a short-term phase and a longer-term phase, and most participants completed both. The reported data shows the following for the two main (primary) outcomes. In the dapagliflozin group, HbA1c levels changed by an average of −0.62 percentage points from the start of the trial to week 26, meaning the figure went down slightly. In the placebo group measured alongside dapagliflozin, HbA1c changed by +0.41 percentage points, meaning it went up slightly. For saxagliptin, the reported average change was +0.06 percentage points, compared with +0.50 percentage points in the placebo group measured alongside it. For the secondary outcomes — which looked at different dosing combinations using a statistical weighting approach — the reported HbA1c changes ranged from −0.79 to +0.07 percentage points across the various dapagliflozin and saxagliptin subgroups, compared with changes of roughly +0.40 to +0.50 percentage points in the corresponding placebo comparisons. 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 ↗
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NCT04657003 · results posted 8 April 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04657003) enrolled 938 people across three groups: 315 received a placebo (a dummy treatment with no active ingredient), 312 received 10 mg of tirzepatide, and 311 received 15 mg of tirzepatide. The trial was measuring changes in body weight over time in people who were taking the study drug alongside other diabetes medications. The vast majority of participants completed the study — 281 in the placebo group, 296 in the 10 mg group, and 282 in the 15 mg group. The reported data shows that, on average, participants in the placebo group lost about 3.3% of their body weight (roughly 3.2 kg) from where they started. In the 10 mg tirzepatide group, the average loss reported was about 13.4% (roughly 13.5 kg), and in the 15 mg group it was about 15.7% (roughly 15.6 kg). The trial also measured how many people reached certain weight-loss milestones. According to the results reported on ClinicalTrials.gov, around 31% of placebo participants lost at least 5% of their body weight, compared with about 82% in the 10 mg group and 86% in the 15 mg group. For a loss of at least 10%, the reported figures were roughly 9% (placebo), 63% (10 mg), and 70% (15 mg). For at least 15%, they were about 3% (placebo), 41% (10 mg), and 52% (15 mg). For at least 20%, the reported figures were approximately 1% (placebo), 23% (10 mg), and 34% (15 mg). 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 ↗
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NCT04707469 · results posted 3 April 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04707469) enrolled 1,606 participants across three groups, each taking a different daily dose of oral semaglutide — 14 mg, 25 mg, or 50 mg. The trial was measuring changes in blood sugar control and body weight in people with type 2 diabetes over about 52 to 68 weeks. Blood sugar control was tracked using a measure called HbA1c, which reflects average blood sugar levels over roughly three months, and fasting plasma glucose (FPG), which is a blood sugar reading taken after not eating overnight. The reported data shows that at 52 weeks, average HbA1c fell by 1.5 percentage points in the 14 mg group, 1.9 percentage points in the 25 mg group, and 2.1 percentage points in the 50 mg group, compared to where each group started. At 68 weeks, the reported reductions were similar: 1.5, 1.8, and 2.0 percentage points respectively. For fasting blood sugar, the reported average reductions at 52 weeks were 2.4 mmol/L (14 mg group), 3.0 mmol/L (25 mg group), and 3.2 mmol/L (50 mg group), with the same figures reported again at 68 weeks. The reported data also shows average body weight reductions at 52 weeks of 4.4 kg in the 14 mg group, 7.1 kg in the 25 mg group, and 8.3 kg in the 50 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04071626 · results posted 13 December 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04071626) enrolled a small number of participants — 5 people in the ertugliflozin (a medication) group and 4 people in the placebo (inactive treatment) group. The trial was looking at whether ertugliflozin made a difference to heart and exercise-related measurements in participants over 12 weeks. Not everyone finished the study: 4 people completed it in the ertugliflozin group and 2 in the placebo group. The reported data shows that the main thing being measured was "peak VO2" — a way of gauging how much oxygen the body uses at peak exercise effort, measured in millilitres per kilogram of body weight per minute. After 12 weeks, the reported change from the starting point was −0.6 ml/kg/min in the ertugliflozin group and −0.1 ml/kg/min in the placebo group, meaning both groups showed a small reduction from where they started. For one of the secondary measures — a blood marker called betahydroxybutyrate (a type of substance the body produces when breaking down fat for energy) — the reported change was −0.045 mmol/L in the ertugliflozin group and −0.018 mmol/L in the placebo group. For the other secondary measure, heart muscle size as assessed by a cardiac MRI scan, no numerical results were reported in the submitted data. It is worth noting that this was a very small trial, and the data as submitted is limited. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02588950 · results posted 18 October 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02588950) enrolled 11 participants in total, split across four sequence groups (sizes of 3, 2, 3, and 3). The trial was studying a concentrated insulin called U-500R, which is a much stronger formulation of insulin than the standard type. It was looking at how the body absorbs and processes this insulin when given in different ways — by injection under the skin or by a continuous pump (Part A), and when given either twice a day or three times a day (Part B). The measurements tracked included how quickly the insulin reached its peak level in the blood, how much insulin was in the blood over time, and how strongly it acted on blood sugar levels. The reported data shows that in Part A, when comparing a single injection to a pump delivery, the time it took for the insulin to reach its highest level in the blood was reported as 6 hours for the injection method and 5 hours for the pump method. The total amount of insulin measured in the blood over time was reported as 5,230 units for the injection group and 6,070 units for the pump group. The time at which the insulin had its strongest blood-sugar-lowering effect was reported as approximately 8.5 hours for both methods. In Part B, comparing twice-daily to three-times-daily dosing, the total insulin measured in the blood over 24 hours was reported as 7,790 units for twice-daily and 11,700 units for three-times-daily. The peak insulin level in the blood was reported as 699 units for twice-daily and 1,050 units for three-times-daily. The maximum rate at which sugar was processed (a measure of how strongly the insulin acted) was reported as 524 mg/min for twice-daily and 588 mg/min for three-times-daily. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04591015 · results posted 28 September 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 172 people in total — 86 in a group receiving an intervention called "DD-CA" and 86 receiving usual care. The trial was measuring three main things: how many participants were readmitted to hospital within 30 days of discharge, and how much a blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over recent months) changed from the start of the study to 90 days and then 180 days later. The trial also tracked hospital readmissions within 90 days, and participants' self-reported emotional stress related to diabetes, using a scoring scale. Not everyone completed the study — 58 people in the DD-CA group and 68 in the usual care group finished. The reported data shows that within 30 days of discharge, 24 participants in the DD-CA group and 13 in the usual care group had at least one hospital readmission. For HbA1c, both groups showed a reduction (a lower number) from their starting point: at 90 days, the DD-CA group's average HbA1c dropped by 2.69 percentage points, while the usual care group's dropped by 1.45 percentage points. At 180 days, the reported drops were 2.03 and 0.91 percentage points respectively. For hospital readmissions within 90 days, 32 people in the DD-CA group and 30 in the usual care group had at least one readmission. The reported data also shows changes in diabetes-related emotional stress, measured on a scale of 1 to 6 where a higher score means greater stress. At 90 days, the DD-CA group's average score dropped by 0.42 points and the usual care group's dropped by 0.31 points. At 180 days, the reported drops were 0.56 and 0.35 points 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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NCT02046395 · results posted 21 August 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02046395) enrolled 28 participants, all in a single group called the "Alternate Antihypertensive Arm." The trial was looking at what happens to kidney-related measurements when a particular type of blood pressure medication — known as ACE inhibitors or ARBs — is temporarily stopped and then restarted. Participants went through several phases: a period on alternative blood pressure medication before the washout, the washout period itself (when the ACE/ARB medication was paused), and a period after the medication was reintroduced. All 28 participants completed most phases, with one person not completing the final phase. The reported data shows two key measurements were tracked. The primary measurement was the change in something called the "urine microalbumin creatinine ratio" — a way of detecting a specific protein in urine that can indicate how the kidneys are filtering. The reported figure for the change in this measure was 15 mg/g. The secondary measurement was the change in "urinary free light chains" — another type of protein in urine also linked to kidney filtering. The reported figure for this change was 1.14 mg/g. No further breakdown of these numbers (such as individual time points or comparisons between phases) 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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NCT04436822 · results posted 2 June 2023
According to the results reported on ClinicalTrials.gov, this trial looked at a continuous glucose monitoring sensor called the DS5, which is a small device worn on the body that measures blood sugar levels. The trial enrolled 172 adults aged 18 to 80 and 138 children aged 2 to 17. Of those, 160 adults and 132 children completed the study. The main thing being measured was how closely the sensor's readings matched blood sugar readings taken by a reference laboratory method — essentially, how often the sensor's numbers were in close agreement with a more precise reference measurement. The reported data shows that for adults wearing the DS5 on the arm, roughly 88.9% of the sensor's readings fell within 20% of the reference measurement. For children wearing the sensor on the arm, the reported figure was 87.5%, and for children wearing it on the buttock, it was 87.9%. In plain terms, the trial was counting what proportion of readings were "close enough" to the reference — defined as within 20% of that reference value (or within a small fixed amount when blood sugar was low). No other outcome measures were included in the data submitted to ClinicalTrials.gov for this 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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NCT00877851 · results posted 16 May 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 84 people in total — 41 in a group that used a computer-based program and 43 in a control group (meaning they did not use the program). By the end of the study, 32 people in the computer-based program group and 38 in the control group had completed it. The trial was measuring several things related to diabetes management, including diabetes knowledge, goal-setting behaviours, diet, physical activity, body measurements, and markers of cardiovascular risk. The reported data shows results for only one of the outcome measures: diabetes knowledge, which was tested using a questionnaire called the ADKnowl. Scores were recorded as the percentage of questions answered correctly. The computer-based program group scored an average of 67% correct, while the control group scored an average of 64% correct. For all other outcomes — including goal setting, dietary intake, physical activity levels, body measurements, and cardiovascular risk markers — no numerical results were reported 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04678284 · results posted 18 April 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04678284) involved 10 people who took part in something called the "D-Homes Intervention." All 10 participants completed the study with no drop-outs. The trial was measuring how acceptable the program was to participants, as well as tracking changes in blood sugar control, psychological wellbeing, and how consistently people took their diabetes medications. The reported data shows that on a satisfaction questionnaire (scored from 8 to 32, where higher means more satisfied), participants scored an average of 25.4. For blood sugar control, the trial used a test called HbA1c, which reflects average blood sugar levels over roughly three months — the reported average change was -0.5 percentage points, meaning the group's average score went slightly down (lower numbers indicate better blood sugar control on this test). For psychological wellbeing, measured on a scale of 20 to 60 where higher scores indicate better day-to-day functioning, the reported average change was -2.6 points, meaning the group's average score went slightly down. For medication-taking habits, measured on a scale of 12 to 48 where higher scores indicate worse outcomes, the reported average change was +0.6 points, meaning the group's average score went slightly up. It is worth noting that this was a very small study of only 10 people and there was no comparison group, so the reported numbers describe what was observed in this one 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05013008 · results posted 31 March 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT05013008) enrolled 951 people in total — 483 in the finerenone group and 468 in the placebo group (a placebo is a dummy treatment with no active ingredient). The trial was measuring changes in the levels of 27 specific proteins in the blood over time, comparing readings taken after 36 months of treatment to readings taken after 4 months of treatment. These protein levels were used as biological markers to track what was happening in participants' bodies during the study. A smaller number of participants — 478 in the finerenone group and 443 in the placebo group — completed the study. The reported data shows the results as ratios, where a number above 1.0 means the protein level was higher at 36 months compared to 4 months, and a number below 1.0 means it was lower. Across the six sets of measurements reported for the 27 pre-defined proteins, the finerenone group had ratios ranging from approximately 0.979 to 1.133, while the placebo group had ratios ranging from approximately 1.062 to 1.224. In plain terms, the reported data shows that protein levels in the placebo group generally appeared to rise more over time compared to the finerenone group, though the specific proteins behind each individual measurement pair were not separately 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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NCT03185741 · results posted 10 March 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 767 people across three groups: one group received something called the "UMS Strategy" (an approach to support medication-taking), a second group received the UMS Strategy plus SMS text message reminders, and a third group received usual care as a comparison. The trial was measuring how well people took their prescribed medications, using several different methods to check this. Numbers of participants who completed each stage were broadly similar across the three groups, with most people finishing the study through to the six-month mark. The reported data shows that the main outcome — measured by physically counting leftover pills to estimate the proportion of medication actually taken — gave very similar results across all three groups at six months. The probability of a person being considered "adherent" (taking 80% or more of their pills) was reported as 0.28 for the UMS Strategy group, 0.29 for the UMS Strategy plus SMS group, and 0.30 for the usual care group. For the secondary outcomes, a 24-hour self-reported recall of medication-taking showed probabilities of 0.72, 0.67, and 0.69 respectively across the three groups. A survey measuring barriers to taking medication (scored from 12 to 60, where higher scores mean more barriers) returned scores of 23.0, 23.89, and 23.22 across the groups. Knowledge of what each medication was for was reported as a probability of 0.73, 0.73, and 0.75 across the three groups respectively. The reported data shows that across all four measures, the numbers were broadly similar between 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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NCT03761797 · results posted 23 January 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,164 people who all had type 2 diabetes. Of those, 1,146 were included in the safety analysis, and 1,025 completed the study, while 139 did not finish. The trial was set up to track unwanted or unexpected reactions that participants experienced while taking the study treatment — these are called adverse drug reactions, which means side effects or other unintended responses believed to be linked to the medicine. The reported data shows that out of the 1,146 people included in the safety analysis, 32 participants experienced an adverse drug reaction during the study period. No other outcome measures — such as measures of blood sugar levels or other health indicators — were included in the structured results 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03650088 · results posted 13 January 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 adults in a single group that took part in a weight loss intervention. Seventeen of the 18 participants completed the study, and one did not finish. The trial was measuring changes in body weight, body mass index (BMI — a number calculated from height and weight), blood sugar control (using a measure called HbA1c, which reflects average blood sugar levels over recent months), and participants' feelings about managing their diabetes and the obstacles they faced in doing so. The reported data shows that, on average, participants' weight fell by 4.54 kilograms over the course of the study, and their BMI dropped by 1.66 units. Their HbA1c — the blood sugar marker — fell by 0.3 percentage points on average. For context, the trial description notes that HbA1c values between 5.7% and 6.4% are considered to indicate pre-diabetes, and 6.5% or above is considered diabetes. Regarding how participants felt about controlling their diabetes (measured using a questionnaire with three sections covering personal control, the influence of healthcare providers, and the role of chance), the reported changes were small: −0.12, −1.35, and +0.65 points respectively on scales ranging from 6 to 36. The reported data also shows changes across nine areas of a diabetes obstacles questionnaire, where lower scores indicate fewer perceived obstacles. The nine areas recorded average changes of −2.88, −2.54, −4.06, −1.24, −3.06, −2.29, −1.00, −0.24, and −0.18 points respectively, all in the direction of fewer reported obstacles. Because the data submitted does not label which number corresponds to which specific area of the questionnaire, a precise breakdown by category cannot 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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NCT04153929 · results posted 29 November 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04153929) enrolled 413 participants across eight groups. Most participants had type 2 diabetes, and the trial was testing different doses of an investigational medicine called BI 456906 — given either once or twice a week by injection — against both a placebo (an inactive dummy injection) and semaglutide (an already-approved diabetes medicine used here for comparison). The main thing the trial set out to measure was the change in HbA1c — a blood test that reflects average blood sugar levels over roughly three months — after 16 weeks. Secondary measurements included changes in body weight and waist circumference. The reported data shows that the placebo group's HbA1c fell by an average of 0.23 percentage points over 16 weeks. By comparison, the BI 456906 groups showed reductions ranging from 0.91 percentage points (lowest dose, 0.3 mg once weekly) up to 1.79 percentage points (1.8 mg once weekly and 1.8 mg twice weekly groups), while the semaglutide group fell by 1.50 percentage points. For body weight, the placebo group lost an average of about 1.3 kg, while BI 456906 groups lost between roughly 1.9 kg and 8.9 kg depending on dose, and the semaglutide group lost about 5.2 kg. When looking at who lost 5% or more of their body weight, this ranged from about 7% of the placebo group up to about 57% in the higher BI 456906 dose groups, compared with 38% in the semaglutide group. Waist circumference reductions also varied across groups, from about 1.8 cm to 12.9 cm for BI 456906 doses, versus 2.0 cm for placebo and 3.6 cm for semaglutide. 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 ↗
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NCT04894916 · results posted 10 November 2022
According to the results reported on ClinicalTrials.gov, this trial involved 59 people with diabetes who used a mobile app called "My Diabetes Care Mobile" (MDC-m). The trial was measuring how easy and satisfying the app was to use, how often participants actually used it, and what their experience of its features was like. It also looked at whether participants' knowledge about diabetes and their confidence in managing their own diabetes changed over the course of the study. Fifty-three of the 59 participants completed the study, and six did not. The reported data shows that on a usability scale running from 0 (worst) to 100 (best), participants gave the app an average score of 81.9 — the scale's designers suggest that scores above 68 are above average and scores of 85 or above suggest excellent usability. For app usage, the reported data shows that 54 participants visited the app at least once during the study period, and 47 of those used it for 10 minutes or more. On the diabetes knowledge measure (scored 0–13), the reported average rose from 5.37 at the start to 6.10 at the end of the study. On the self-confidence measure (scored 8–40, with higher meaning more confident), the reported average moved from 29.12 to 30.29. For participants' knowledge of specific diabetes health targets — such as blood pressure and blood sugar measures — the numbers who answered questions correctly also appear to have shifted between the start and end of the study period, though the full breakdown of those figures was reported without labels distinguishing which question each number refers to. The reported data also includes counts of participants who found various app features useful, though the specific feature names were not included in the submitted data, so a detailed feature-by-feature breakdown cannot 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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NCT04450394 · results posted 2 November 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04450394) enrolled 278 participants across three groups: 129 people received LY3209590 with a paper-based dosing guide (Algorithm 1), 135 people received insulin degludec (a comparator insulin already in use), and 14 people received LY3209590 with a digital dosing guide (Algorithm 2). The trial was primarily measuring changes in a blood marker called HbA1c — a measure of average blood sugar levels over roughly two to three months — comparing LY3209590 against insulin degludec. Note that the third group (digital algorithm) was not included in the primary or secondary outcome comparisons reported below, and the data was not reported for that group in those measures. The reported data shows that, on average, participants in the LY3209590 paper-algorithm group had their HbA1c fall by 1.20 percentage points from their starting level, while those in the insulin degludec group had a fall of 1.26 percentage points. For fasting blood sugar (a blood glucose reading taken after not eating overnight), the reported average reduction was 50.7 mg/dL in the LY3209590 group and 58.7 mg/dL in the insulin degludec group. The trial also recorded how often participants experienced low blood sugar episodes (defined as a self-monitored reading below a set threshold): the reported rate was 0.21 episodes per person per year in the LY3209590 group and 0.15 episodes per person per year in the insulin degludec group. Finally, a measurement of how LY3209590 moved through the body (called area under the concentration-time curve, or AUC — essentially a summary of drug levels in the blood over time) was reported only for the LY3209590 paper-algorithm group, with a value of 5,890 nmol·hr/L at week 26. 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 ↗
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NCT03521934 · results posted 28 October 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03521934) enrolled 608 people in the sotagliflozin group and 614 people in the placebo group — a total of 1,222 participants. The trial was measuring heart-related events in people with heart failure, specifically looking at how often participants experienced a combination of death from heart or cardiovascular causes, hospital admissions for heart failure, and urgent medical visits for heart failure. It is noted that zero participants were recorded as having formally "completed" the study in the usual sense, which the data indicates reflects how the trial's endpoint tracking was structured rather than everyone dropping out. The reported data shows that the main (primary) outcome — that combined count of cardiovascular deaths, heart failure hospitalisations, and urgent heart failure visits — was recorded at 51 events per 100 person-years in the sotagliflozin group, compared with 76.3 events per 100 person-years in the placebo group. "Events per 100 person-years" is a way of counting how many events occurred relative to the total time all participants were followed, allowing fair comparison between groups. For the secondary outcomes, hospital admissions and urgent heart failure visits combined were reported at 40.4 versus 63.9 events per 100 person-years (sotagliflozin vs placebo). Deaths from cardiovascular causes were reported at 10.6 versus 12.5, and deaths from any cause at 13.5 versus 16.3 events per 100 person-years respectively. A broader combined measure covering cardiovascular death, heart failure hospitalisations, non-fatal heart attack, and non-fatal stroke was reported at 51.4 versus 71.0 events per 100 person-years. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01154933 · results posted 6 October 2022
According to the results reported on ClinicalTrials.gov, this trial involved 24 participants in total — 12 people received exenatide (a medication injected twice daily) and 12 received a placebo (an inactive injection). All 24 participants completed both phases of the trial: one phase using a 5 microgram dose and another using a 10 microgram dose. The trial was looking at people with obese type 2 diabetes who were already on insulin, and it measured several things over 12 weeks, including fasting insulin levels (insulin in the blood after not eating), body weight, HbA1c (a measure of average blood sugar levels over roughly three months), and a biological marker related to inflammation in the body. The reported data shows the following numbers at the end of the 12-week period. For fasting insulin levels (measured in standard units), the exenatide group recorded 16.4 and the placebo group recorded 13.9 — the data also includes earlier readings of 12.7 and 13.1 respectively, though the timing context for all four figures was not fully detailed in the submitted results. For body weight, the reported data shows the exenatide group had a change of 0 pounds and the placebo group had a change of 3 pounds, though whether this represents a gain or loss was not explicitly labelled in the data. For HbA1c, the exenatide group showed a change of −1.2% and the placebo group showed a change of −0.5%. For the inflammation-related biological marker (NFκB binding activity), the exenatide group recorded a 26% ratio and the placebo group recorded 0%. It is worth noting that the submitted data did not include separate reported results for the 5 microgram dose phase — the outcome figures provided relate to the 10 microgram exenatide group 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03681691 · results posted 27 September 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 12 post-menopausal women in total — 8 who had diabetes and 4 who did not have diabetes. Of these, 6 women with diabetes and 3 without diabetes completed the study, while 2 and 1 respectively did not finish. The trial was measuring how the brain uses two types of fuel — glucose (a sugar) and acetoacetate (a ketone body, which is an alternative energy source) — using a brain-scanning technique called PET imaging. It also looked at short-term memory and thinking skills in the two groups. The reported data shows that, when measuring how much glucose the brain took up, women without diabetes recorded figures of 12.28 and 8.74 micromoles per minute per 100 grams of brain tissue (measured at two separate time points), while women with diabetes recorded 11.75 and 6.87 in the same units. For ketone body uptake, women without diabetes recorded 0.031 and 0.027, while women with diabetes recorded 0.024 and 0.028, in the same units. Regarding the "change in uptake" primary outcome — which was intended to look at shifts in how the brain uses glucose versus ketones over time — no measurement values were reported in the submitted data. The reported data also shows a memory composite score (a combined score where higher numbers suggest better performance on memory tests, ranging from −2 to +2). Women without diabetes recorded scores of 1.04 and 1.56, while women with diabetes recorded −0.52 and −0.56. It is worth noting that this was a very small study, and the data was submitted to ClinicalTrials.gov as recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02963766 · results posted 1 July 2022
According to the results reported on ClinicalTrials.gov, this trial involved 154 participants split across three groups: 51 received a placebo followed by the lower dose of a medicine called dulaglutide, 51 received the lower dose (0.75 mg) of dulaglutide throughout, and 52 received the higher dose (1.5 mg). The trial was measuring changes in blood sugar control over 26 weeks, primarily by looking at a blood marker called HbA1c — a measure of average blood sugar levels over roughly two to three months. It also looked at fasting blood sugar (a single morning reading after an overnight fast), body mass index (BMI), and how many participants reported episodes of low blood sugar (hypoglycaemia). The reported data shows that after 26 weeks, the placebo group's HbA1c rose by an average of 0.5 percentage points, while the combined dulaglutide groups saw an average fall of 0.7 percentage points. Looking at the doses separately, the lower dose group showed a fall of 0.5 percentage points and the higher dose group a fall of 1.0 percentage points. For fasting blood sugar (measured in millimoles per litre), the placebo group's levels rose by 0.96, while the lower dose group fell by 0.47, the higher dose group fell by 1.54, and the combined dulaglutide group fell by 1.03. The reported data also shows that approximately 18% of placebo participants reached an HbA1c at or below 7.0%, compared with 60% in the lower dose group, 53% in the higher dose group, and 57% in the combined dulaglutide group. Changes in BMI were small across all groups (ranging from 0.0 to −0.2 kg/m²). Regarding self-reported episodes of low blood sugar, approximately 2% of the placebo group reported an episode, compared with about 4% in each of the dulaglutide dose 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02545049 · results posted 15 April 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02545049) enrolled 7,437 participants in total — 3,723 in the finerenone group and 3,714 in the placebo group. The trial was measuring heart and kidney outcomes in people who received either finerenone or a placebo (an inactive dummy tablet). The main thing researchers were tracking was how many people experienced a serious heart-related event — specifically, cardiovascular death, a heart attack, a stroke, or being hospitalised for heart failure — whichever happened first. The reported data shows that, for the primary (main) outcome, 458 participants in the finerenone group and 519 participants in the placebo group experienced one of those serious heart events. For kidney-related outcomes, the trial also tracked how many people experienced kidney failure, a significant drop in kidney function (measured by a test called eGFR falling by 40% or more), or death from kidney disease: 350 in the finerenone group and 395 in the placebo group reached that milestone. A stricter version of that kidney measure (eGFR falling by 57% or more) was reached by 108 people taking finerenone and 139 taking placebo. The reported data also shows that 1,573 finerenone participants and 1,605 placebo participants were hospitalised for any reason, and 333 versus 370 participants respectively died from any cause during the study period. One additional measure tracked a urine test called the albumin-to-creatinine ratio (UACR), which is used as a marker of kidney stress. The reported data shows that at four months, this ratio had changed to 0.624 times the starting level in the finerenone group and 0.922 times the starting level in the placebo group — meaning the ratio was lower than it started in both groups, but more so in the finerenone 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 ↗ · Linked publication on PubMed ↗
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NCT02765399 · results posted 12 April 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people in total — 16 received a medication called liraglutide and 7 received a placebo (a dummy treatment with no active ingredient). Almost all participants finished the trial: 15 out of 16 in the liraglutide group and all 7 in the placebo group. The trial was measuring several things before and after the treatment period, including the amount of fat stored in the liver, fat levels in the blood after eating a fatty meal, body weight, and markers related to blood sugar control (HbA1c, fasting glucose, and insulin levels). The reported data shows the following before-and-after figures for each group. For liver fat content (measured by MRI scan), the liraglutide group went from 14.8% to 10.7%, while the placebo group went from 16.1% to 13.9%. For blood fat levels after a fatty meal (measured over 8 hours), the liraglutide group went from 22.0 to 17.1 units, while the placebo group went from 17.5 to 19.0 units. For body weight, the liraglutide group went from an average of 98.6 kg to 96.1 kg, and the placebo group from 92.0 kg to 89.8 kg. For the blood sugar marker HbA1c (a measure of average blood sugar over several months), the liraglutide group went from 7.0% to 6.4%, while the placebo group remained at 6.3% to 6.4%. For fasting blood glucose, the liraglutide group went from 8.3 to 6.4 mmol/L, and the placebo group from 6.5 to 6.4 mmol/L. For insulin levels in the blood, the liraglutide group went from 13.9 to 14.5 µU/mL, and the placebo group from 13.8 to 14.1 µU/mL. It is worth noting that this was a small trial with just 23 participants across both groups, so the reported numbers reflect a limited sample of people. The results as submitted relate to measurements taken before and after the intervention, and are described in full in a published research article (Matikainen et al., *Diabetes, Obesity and Metabolism*, 2019). 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 ↗
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NCT03730662 · results posted 14 February 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03730662) enrolled 2,002 people across four groups: those receiving weekly injections of tirzepatide at one of three doses (5 mg, 10 mg, or 15 mg) or a daily injection of insulin glargine (a long-acting insulin). The trial ran for 52 weeks, with an additional variable-length follow-up period. The main thing being measured was the change in HbA1c — a blood test that reflects average blood sugar levels over roughly three months, expressed as a percentage. By the end of the 52-week treatment period, the large majority of participants in all four groups completed the trial. The reported data shows the following changes in HbA1c from the start of the trial to the end: the 10 mg tirzepatide group showed an average reduction of 2.43 percentage points, the 15 mg group showed a reduction of 2.58 percentage points, and the insulin glargine group showed a reduction of 1.44 percentage points. For the secondary outcome looking at the 5 mg tirzepatide group, the reported reduction was 2.24 percentage points, compared to 1.44 percentage points for insulin glargine. The reported data also shows changes in body weight: the 5 mg group averaged a reduction of 7.1 kg, the 10 mg group 9.5 kg, the 15 mg group 11.7 kg, while the insulin glargine group averaged an increase of 1.9 kg. Regarding the proportion of participants whose HbA1c fell below 7.0% (a commonly used blood sugar target), the reported figures were approximately 81% for the 5 mg group, 88% for the 10 mg group, 91% for the 15 mg group, and 51% for the insulin glargine group. The reported data also shows reductions in fasting blood sugar levels (measured in mg/dL) across all groups: roughly 50 mg/dL for 5 mg tirzepatide, 55 mg/dL for 10 mg, 59 mg/dL for 15 mg, and 51 mg/dL for insulin glargine. Daily average blood sugar readings taken across seven time points each day also showed reductions in all groups, ranging from around 58–66 mg/dL across the tirzepatide doses and 46 mg/dL for 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02489942 · results posted 4 February 2022
According to the results reported on ClinicalTrials.gov, this trial followed 8,145 people with type 2 diabetes who were already taking JARDIANCE® (empagliflozin) at either a 10 mg or 25 mg daily dose. The trial was an observational study — meaning researchers watched what happened in real-world use rather than comparing the medicine against a placebo or different treatment. It tracked how many people experienced unwanted reactions to the medicine, and also measured changes in two blood sugar-related readings over time. Of the 8,145 people who started, 4,729 completed the study, while 3,416 did not complete it (the reasons were not detailed in the reported data). The reported data shows that 1,029 out of the 8,145 participants experienced an adverse drug reaction — that is, an unwanted effect considered related to the medicine. For the blood sugar measurements, the data shows an average change in HbA1c (a blood test that reflects average blood sugar levels over roughly three months) of −0.74 percentage points from the start of the observation period to the last recorded measurement. The reported data also shows an average change in fasting plasma glucose (a blood sugar reading taken after not eating) of −30.1 mg/dL (milligrams per decilitre, a standard unit for measuring sugar in blood) 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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NCT02924064 · results posted 28 January 2022
According to the results reported on ClinicalTrials.gov, this trial looked at whether adding a medicine called teneligliptin to metformin (a common diabetes tablet) made a difference compared to adding a dummy tablet (placebo) to metformin. A total of 247 people took part — 123 in the teneligliptin group and 124 in the placebo group. The main thing the trial measured was a blood marker called HbA1c, which gives an idea of average blood sugar levels over a few months. It was measured at the start of the trial and again after 24 weeks to see how much it changed. The reported data shows that, after 24 weeks, the teneligliptin plus metformin group had an average HbA1c that was 0.72 percentage points lower than at the start of the trial. In the placebo plus metformin group, the average HbA1c was almost unchanged, dropping by just 0.01 percentage points. The trial also measured fasting plasma glucose — that is, blood sugar levels after not eating overnight. The reported data shows the teneligliptin group's fasting blood sugar fell by an average of 13.5 mg/dL (a unit used to measure sugar in the blood), while the placebo group's fasting blood sugar actually rose by an average of 3.0 mg/dL over the same period. It is worth noting that more people did not complete the trial in the placebo group (43 people) compared to the teneligliptin group (24 people), which may be worth discussing with a healthcare professional when thinking about what these 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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NCT03656744 · results posted 29 December 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03656744) enrolled 101 people in total — 34 in the lower-dose group (500 mg of HTD1801 twice daily), 34 in the higher-dose group (1,000 mg twice daily), and 33 in the placebo group (an inactive treatment given in the same way). The trial was measuring changes in liver fat and blood sugar markers over 18 weeks in people who received either the study drug HTD1801 or a placebo. The reported data shows that the main thing being measured was the change in the amount of fat in the liver, assessed using a specialised MRI scan. At 18 weeks, the reported average reduction in liver fat was approximately 2.9 percentage points in the lower-dose group, 4.8 percentage points in the higher-dose group, and about 2.0 percentage points in the placebo group. In terms of relative (proportional) change, the reported figures were around a 15% reduction in the lower-dose group, 24% in the higher-dose group, and 8% in the placebo group. Looking at individual participants, 6 people in the lower-dose group, 10 in the higher-dose group, and 7 in the placebo group achieved at least a 30% relative reduction in liver fat. Only 1 participant (in the lower-dose group) reached a liver fat level below 5%, which is considered a normal range; none did so in the other two groups. For blood sugar markers, the reported average fasting glucose levels at week 18 were 120 mg/dL (lower dose), 129 mg/dL (higher dose), and 131 mg/dL (placebo) — though the starting values were not included in the submitted data, so the change from baseline cannot be calculated here. A related blood sugar measure called HbA1c (a longer-term indicator of blood sugar levels) showed reported changes of –0.3% (lower dose), –0.6% (higher dose), and +0.1% (placebo) from the start 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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NCT03865381 · results posted 24 September 2021
According to the results reported on ClinicalTrials.gov, this trial involved 60 people who took part in a "Virtual Diabetes Clinic" program. Of those, 55 people completed the study, while 5 did not finish. The trial was measuring changes in blood sugar control and weight over a four-month period, using a combination of standard blood tests and continuous glucose monitors (small wearable sensors that track blood sugar levels throughout the day). The reported data shows that, on average, participants' HbA1c levels — a blood test that reflects average blood sugar levels over roughly three months — changed by minus 1.6 percentage points over the four months. Average body weight changed by minus 9.0 pounds (approximately 4 kg). For the continuous glucose monitor readings, the reported data shows that average glucose levels changed by minus 14.6 mg/dL (a unit used to measure sugar concentration in the blood). The amount of variation in blood sugar levels — that is, how much blood sugar levels fluctuated up and down — changed by minus 1.6 percentage points. The proportion of time participants' blood sugar stayed within a target range of 70 to 180 mg/dL changed by plus 10.2 percentage points. For the outcome measuring the time it took for diabetes medication or dosage to first be changed, no data 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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NCT02540993 · results posted 19 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02540993) enrolled a total of 5,734 participants, split almost evenly between two groups — 2,866 people received finerenone and 2,868 received a placebo (an inactive dummy treatment). The trial was measuring kidney-related outcomes over time, specifically looking at how many people in each group experienced serious kidney events such as kidney failure, a large sustained drop in kidney filtering ability (called eGFR), or death from kidney disease. It also tracked heart and blood vessel events, deaths from any cause, hospitalisations, and a urine test that reflects kidney stress. The reported data shows that for the main (primary) kidney outcome, 504 participants in the finerenone group and 600 in the placebo group experienced one of those serious kidney events. For the combined heart and blood vessel outcome — which included heart-related death, heart attack, stroke, or hospitalisation for heart failure — the reported numbers were 367 in the finerenone group and 420 in the placebo group. Deaths from any cause were reported as 219 in the finerenone group and 244 in the placebo group. For all-cause hospitalisation, 1,263 finerenone participants and 1,321 placebo participants were recorded as having at least one hospital stay. A urine test measuring kidney stress (called UACR) was also reported: at four months, the ratio of the result compared to the starting value was 0.655 in the finerenone group and 0.952 in the placebo group (a lower ratio meaning the level had fallen more from where it started). For a stricter version of the kidney composite outcome (using a steeper decline threshold), 252 finerenone participants and 326 placebo participants experienced an 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04198948 · results posted 15 July 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people in total, split into two groups of 7 and 8. It used a "crossover" design, meaning everyone took both treatments at different times — one group took omeprazole (a common stomach acid-reducing medicine) first, then switched to a placebo (a dummy pill), while the other group did it the other way around. There was a 10-day wash-out break between the two phases to clear each treatment from the body. The trial was measuring how the body absorbs and processes gliclazide (a medicine used for type 2 diabetes) when taken with omeprazole compared to when taken with a placebo. One participant did not complete the second period of the trial. The reported data shows the following numbers across the three outcome measures. For the primary outcome — how much gliclazide was absorbed into the bloodstream over time (measured as a running total of drug levels, called "area under the curve") — the reported figure was 3.73 μg·h/mL when gliclazide was taken with omeprazole, compared with 3.29 μg·h/mL when taken with placebo. For the secondary outcomes, the running total of blood glucose levels over 12 hours was reported as 4.6 mmol·h/L with omeprazole and 4.0 mmol·h/L with placebo. The running total of insulin levels over 12 hours was reported as 231.6 mIU·h/L with omeprazole and 265.9 mIU·h/L with placebo. No further statistical detail was 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03386344 · results posted 25 June 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03386344) enrolled 376 people across three groups: 126 received a placebo (a dummy treatment), 125 received a 200 mg dose of sotagliflozin, and 125 received a 400 mg dose of sotagliflozin. The trial ran for 26 weeks and was primarily measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly three months. It also tracked several other measurements including bone density at different parts of the body, body weight, and fasting blood sugar levels. It is worth noting that only 9 participants in each group were recorded as having completed the study, with the large majority recorded as not completing it; the reported data does not explain why. The reported data shows that for the primary measure — change in HbA1c — the placebo group's levels fell by an average of 0.22 percentage points, while both sotagliflozin groups saw a larger average fall of 0.66 and 0.67 percentage points respectively. For body weight, the placebo group lost an average of 0.46 kg, compared to 2.37 kg in the 200 mg group and 2.16 kg in the 400 mg group. Fasting blood sugar also fell more in the sotagliflozin groups (around 26–29 mg/dL) than in the placebo group (around 7 mg/dL). For bone density, small changes were recorded across all three sites measured (lumbar spine, total hip, and femoral neck), with figures ranging from slight increases to slight decreases across all groups; the differences between groups were modest. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01807221 · results posted 15 June 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,066 people across six treatment groups. One group received an existing medicine called eplerenone (224 people), while the remaining five groups received different dose ranges of an investigational medicine called finerenone (ranging from 165 to 173 people per group). The trial was primarily measuring a blood marker called NT-proBNP — a substance linked to heart stress that doctors use when assessing heart failure — and whether it dropped by more than 30% over 90 days. The trial also tracked a number of secondary outcomes including deaths, hospital admissions for heart-related reasons, and emergency presentations for worsening heart failure. The reported data shows that, for the primary outcome, the percentage of participants whose NT-proBNP levels fell by more than 30% from the start to day 90 were: 37.2% in the eplerenone group, and 30.9%, 32.5%, 37.3%, 38.8%, and 34.2% across the five finerenone dose groups respectively. For the secondary outcomes, the reported numbers of deaths from any cause ranged from 0 to 6 participants across the groups, cardiovascular hospitalisations ranged from 7 to 28 participants, and emergency presentations for worsening heart failure ranged from 7 to 21 participants. The reported data also shows changes in a related blood marker (BNP), with ratios compared to starting levels generally falling between approximately 0.71 and 0.98 across all groups at various timepoints — a ratio below 1.0 meaning the level was lower than at the start. 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 ↗
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NCT03152084 · results posted 28 May 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03152084) involved 24 participants in total — 17 people in one group (Group 2, described as people with type 2 diabetes and preserved kidney function) and 7 people in a second group (Group 3, described as people without diabetes but with impaired kidney function). All 24 participants who started the trial also completed it. The trial was measuring how a medicine called dapagliflozin affected the amount of sodium (salt) and glucose (sugar) passed out in urine over 24 hours, as well as blood pressure. The reported data shows the following numbers for the primary outcome — the change in sodium passed in urine from the start of the study to early in the treatment period (days 2–4). Group 2 showed an average change of −5.33 mmol per 24 hours (meaning slightly less sodium in the urine), while Group 3 showed a larger average change of −27.67 mmol per 24 hours. For the secondary outcomes, the reported data shows that by the end of the treatment period (days 12–14), the average change in urinary sodium compared to baseline was +2.67 mmol/24hr for Group 2 and −23.83 mmol/24hr for Group 3. After treatment stopped (the follow-up period), those figures shifted to +1.33 and +6.17 mmol/24hr respectively. Regarding glucose in the urine, both groups showed increases during treatment (Group 2: +302.61 mmol/24hr at the start of treatment, +283.40 at the end; Group 3: +43.93 and +29.88 respectively), with those numbers falling again after treatment ended. For 24-hour systolic blood pressure (the top number in a blood pressure reading), the reported average change from baseline to day 4 was −5.48 mmHg in Group 2 and −8.97 mmHg in Group 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 ↗
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NCT02119819 · results posted 14 April 2021
According to the results reported on ClinicalTrials.gov, this trial involved 420 adults in total, spread across six groups. Four groups received different doses of an investigational medicine called LY2944876 (10 mg, 15 mg, 30 mg, or 50 mg), one group received an already-approved diabetes medicine called exenatide extended-release, and one group received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring changes in a blood marker called HbA1c — a routine blood test that gives an average picture of blood sugar levels over roughly two to three months — after 12 weeks of treatment. The reported data shows that at the 12-week mark (the main measurement point), average HbA1c levels fell from where they started by 1.07 percentage points in the 10 mg LY2944876 group, 1.09 points in the 15 mg group, 1.44 points in the 30 mg group, and 1.33 points in the 50 mg group. The exenatide group saw a reported fall of 1.42 points, while the placebo group saw a fall of 0.29 points. At 24 weeks, the reported falls were broadly similar across those groups. The reported data also shows changes in body weight: across the four LY2944876 doses, average body weight fell by between roughly 1.1% and 3.4%, compared with around 1.2–1.7% in the placebo group and about 2.0–2.2% in the exenatide group (two time-point measurements were reported for each group). Fasting blood glucose levels and blood sugar readings taken at seven points during the day also showed reported reductions across all active-treatment groups compared with placebo. Some lipid (blood fat) measurements were also reported, though the data as submitted covers only two lipid types and the figures varied across groups and 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02114814 · results posted 2 February 2021
According to the results reported on ClinicalTrials.gov, this trial involved 186 people in total — 103 in the intervention group and 83 in the attention control group (a comparison group that received a different type of support). By the end of the study, 88 people in the intervention group and 74 in the control group had completed the trial. The trial was measuring blood sugar control over time, using a test called HbA1c (a percentage figure that reflects average blood sugar levels over roughly three months), as well as health-related quality of life. The reported data shows HbA1c percentages recorded at multiple points across the study. For the intervention group, the reported HbA1c figures across the different time points were 8.5%, 7.7%, 7.7%, and 8.4%. For the attention control group, the corresponding figures were 9.4%, 8.7%, 9.0%, and 8.2%. Regarding quality of life, participants completed a survey called the SF-12, which produces two scores out of 100 — one for physical health and one for mental health, where higher numbers indicate better perceived quality of life. The reported data shows physical health scores of 49.5 and 50.6 for the intervention group and 49.1 and 49.5 for the control group across the two time points measured. Mental health scores were reported as 47.2 and 47.7 for the intervention group, and 50.0 and 51.7 for the 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03338855 · results posted 15 January 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03338855) enrolled 26 people in total — 12 in one group and 14 in the other. It used a "crossover" design, meaning participants took both dapagliflozin 10 mg (a tablet used in type 2 diabetes) and a placebo (a dummy pill with no active ingredient) at different times, each for five weeks. The main thing the trial set out to measure was how well muscles responded to insulin — specifically, how efficiently the body disposed of glucose (blood sugar) during a carefully controlled laboratory test called a euglycaemic hyperinsulinaemic clamp, which involves slowly infusing insulin and sugar while keeping blood sugar levels steady. The reported data shows that, on the primary measure — the corrected glucose disposal rate (a number reflecting how much glucose the muscles took up per kilogram of body weight per minute) — the dapagliflozin group recorded a value of 8.523 micromoles/kg/minute, compared with 9.592 micromoles/kg/minute in the placebo group. The reported data also shows figures for several other pre-specified measurements: the change in the body's own glucose production was reported as −4.656 (dapagliflozin) versus −2.591 (placebo) at a lower insulin level, and −10.803 versus −8.512 at a higher insulin level. A measure of how the body shifts between burning fat and carbohydrates (called the respiratory exchange ratio, or RER) was 0.101 versus 0.089 during the clamp test, and 0.812 versus 0.835 over a full 24-hour period. Daily energy use was reported as 9.519 versus 9.628 megajoules per day. Body composition figures — fat mass and lean (muscle) mass — were reported as approximately 25,318 g versus 25,565 g for fat, and 59,929 g versus 60,595 g for lean mass, respectively. It is worth noting that no variability figures (such as standard deviations) or statistical comparison results were included in the data submitted to ClinicalTrials.gov, so it is not possible from this information alone to judge how meaningful the differences between numbers may be. 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 ↗
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NCT03270436 · results posted 9 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 380 participants across two groups: 213 people joined the "WORD" (Wholeness, Oneness, Righteousness, Deliverance) Diabetes Prevention Program and 167 joined the "PILI" (Partnership for Improving Lifestyle Intervention) Diabetes Prevention Program. The trial measured changes in body weight, blood sugar levels (using a measure called HbA1c — a percentage that reflects average blood sugar over a few months), blood pressure, sugary drink consumption, and fruit and vegetable intake. Measurements were taken at the start of the program, immediately after it finished, and again six months later. The reported data shows the following average figures across both groups at the three time points. For **body weight**, the WORD group started at around 86.4 kg, and this figure was similar immediately after the program (86.5 kg) and slightly lower at six months (86.2 kg). The PILI group started at around 84.3 kg, remained similar after the program (84.4 kg), and was recorded at 83.8 kg at six months. For **HbA1c**, the WORD group went from 7.27% at the start to 7.32% immediately after, then 7.25% at six months; the PILI group went from 7.66% to 7.55% then 7.61%. For **systolic blood pressure** (the top number in a blood pressure reading), the WORD group went from 129.4 to 126.8 to 120.8 mmHg, while the PILI group went from 128.2 to 119.7 to 118.3 mmHg. **Diastolic blood pressure** (the bottom number) followed a similar pattern, moving from 79.6 to 78.5 to 76.4 mmHg in the WORD group, and from 78.3 to 74.1 to 76.2 mmHg in the PILI group. For **sugary drink consumption**, both groups reported drinking fewer sugary drinks over time — the WORD group went from 1.65 drinks per day at the start to 1.18 at six months, and the PILI group from 2.16 to 1.40. For **fruit and vegetable consumption** (scored on a scale of 0 to 6, where higher means more frequent), the WORD group went from 3.59 to 4.10, and the PILI group from 3.70 to 3.80. 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 ↗
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NCT01033773 · results posted 5 October 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 86 people, all of whom took part in a single programme combining diabetes education with medication management. Of those 86 participants, 51 completed the study and 35 did not finish. The trial was measuring three things: how often participants had a low blood sugar episode (blood glucose below 60 mg/dL) in the 24 hours around their emergency department visit, how their average blood sugar level changed over 30 days, and how their HbA1c changed over 30 days. HbA1c is a blood test that reflects average blood sugar levels over roughly the past two to three months, expressed as a percentage. The reported data shows that for the primary outcome — low blood sugar events in the 24 hours around the baseline emergency department visit — the number recorded was zero events. For the secondary outcomes, the reported data shows an average blood sugar reading of 356 mg/dL at the start of the programme and 183 mg/dL at the 30-day mark. For HbA1c, the reported figures were an average of 12.0% at the start and 11.6% at 30 days. Because this trial had only one group and no comparison group, these numbers reflect changes within the same group of participants over time, rather than a comparison against a separate untreated group. It is worth noting that 35 out of 86 participants did not complete the study, which the reported data does not fully explain, and no information about reasons for non-completion was 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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NCT01490918 · results posted 17 August 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 165 people across three groups, all of whom were taking combinations of diabetes-related medicines (metformin, sitagliptin, acarbose, or a placebo standing in for one of those medicines). The trial was mainly measuring changes in a blood marker called HbA1c — a way of tracking average blood sugar levels over roughly three months — after 16 weeks of treatment. Of the 165 people who started, 126 completed the study. The reported data shows that after 16 weeks, the group taking a placebo alongside metformin and sitagliptin had an HbA1c change of −0.09% from their starting level, the group taking all three active medicines (sitagliptin, metformin, and acarbose) had a change of −0.44%, and the group taking acarbose and sitagliptin with a metformin placebo had a change of +0.84%. At 24 weeks, the reported changes were −0.34%, −0.47%, and +0.23% respectively for the same three groups. The trial also measured blood sugar levels two hours after a meal at 24 weeks, reporting changes of −1.73 mmol/L, −1.76 mmol/L, and +0.06 mmol/L across the three groups. Additional measurements looked at how blood sugar and insulin levels changed over the course of a test meal at 16 weeks (comparing just the first two groups), as well as levels of a gut hormone called GLP-1; those figures were also reported but no interpretation of their meaning 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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NCT03786718 · results posted 7 July 2020
According to the results reported on ClinicalTrials.gov, 67 people with diabetes took part in this single-group trial, and 60 of them completed it. The trial was testing a patient-facing diabetes dashboard — a digital tool that lets people see their own diabetes health data. The study measured how easy the dashboard was to use (called "usability"), what participants thought of the experience using it, and how they actually used the system over the study period of about one month. It also looked at whether participants' diabetes knowledge and self-care activities changed between the start and end of the study. The reported data shows that on a usability scale running from 0 (worst) to 100 (best), participants scored the dashboard an average of 78.8, which sits above the 68-point threshold the scale's designers describe as "above average" usability. For user experience, the reported data shows varying numbers of participants rated different features of the dashboard as useful or helpful for understanding their health data, though the detailed breakdown of which specific numbers correspond to which features was not fully labelled in the submitted data. Five areas for improvement were identified through follow-up interviews with a subset of participants. For the secondary outcomes, the reported data shows that diabetes knowledge scores (out of 13) were 11.0 at the start and 11.0 at the end of the study — no change between the two time points. Self-care activity scores, measured in days per week across areas like diet, exercise, and blood glucose testing, showed small changes across the different categories, though again the detailed labelling of each number to its specific category was not fully 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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NCT01528254 · results posted 15 April 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 998 people in the vildagliptin (50mg twice daily) plus metformin group and 1,003 people in the placebo plus metformin group — just under 2,000 participants in total. The trial was measuring how long it took for blood sugar control to break down in people with type 2 diabetes already taking metformin. Blood sugar control was tracked using a measure called HbA1c, which reflects average blood sugar levels over roughly three months. "Treatment failure" was defined as having two visits in a row where HbA1c rose to 7.0% or above. The reported data shows that over time, a higher proportion of participants in the placebo plus metformin group reached that treatment failure point compared to those in the vildagliptin plus metformin group. For example, by one of the later reported time points, the reported failure rates were approximately 52.7% in the vildagliptin group versus 74.4% in the placebo group. For the secondary outcomes, the reported rate at which HbA1c rose over time during the first treatment period was 0.24% per year in the vildagliptin group and 0.27% per year in the placebo group. During the second treatment period, those rates were 1.11% and 1.02% per year respectively. A separate measure of how well insulin-producing cells in the pancreas were functioning showed a reported rate of change of −1.04% per year in the vildagliptin group and −0.46% per year in the placebo group by the end of the study, though the data as submitted does not include further detail to fully explain the difference in direction or magnitude of these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT03550378 · results posted 13 April 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people in total — 20 received a placebo (an inactive substance) and 21 received the investigational medicine MEDI0382. All 20 placebo participants and 20 of the 21 MEDI0382 participants completed the study. The trial was measuring how blood sugar levels changed after eating a standardised liquid meal, specifically looking at the total amount of glucose (sugar) in the blood over a four-hour period following the meal. This type of test is called a Mixed-Meal Tolerance Test. The reported data shows that, from the start of the study to Day 32, the placebo group's post-meal blood glucose level (measured as an area under the curve — essentially a running total of glucose over time) increased by about 3.7%, while the MEDI0382 group's level decreased by about 26.7%. Regarding unwanted medical events that occurred during the study (called adverse events), the reported data shows that 13 out of 20 placebo participants and 20 out of 21 MEDI0382 participants experienced at least one such event. Two participants in each group experienced a serious adverse event. No participants in either group had abnormal vital signs (such as blood pressure or pulse) recorded as a treatment-related event. Small numbers of participants in both groups had abnormal heart tracing (ECG) or laboratory test results noted as treatment-related events. 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 ↗
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NCT02608905 · results posted 8 April 2020
According to the results reported on ClinicalTrials.gov, this trial looked at two groups of people with type 2 diabetes — 7 who received a medication called dapagliflozin and 10 who received a placebo (a dummy treatment with no active ingredient). The trial was measuring two things: changes in a marker of inflammation in certain blood cells (called NFkappaB, which is a protein involved in the body's inflammatory response), and changes in how well the arteries expand in response to increased blood flow (measured using ultrasound). Of those who started the trial, 5 out of 7 in the dapagliflozin group and all 10 in the placebo group completed it. The reported data shows that, unfortunately, no numerical results were submitted to ClinicalTrials.gov for either the primary outcome (the inflammation marker) or the secondary outcome (the artery flexibility measure). This means it is not possible to describe what the measurements actually found — the figures were simply not reported in the data made 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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NCT03214380 · results posted 27 March 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03214380) involved people with diabetes who use mealtime insulin. During a lead-in period, 933 people started on a standard insulin called insulin lispro (Humalog). After that phase, 837 people moved into the main treatment period, where they were split into groups: some continued on insulin lispro, and others switched to a newer insulin called LY900014 (also known as ultra-rapid lispro). The trial's main goal was to measure changes in a blood sugar control marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly three months — after 26 weeks of treatment. The reported data shows that, at 26 weeks, both groups had lower HbA1c levels than at the start. The insulin lispro group's HbA1c fell by an average of 0.43 percentage points, while the LY900014 group's fell by 0.38 percentage points. For the secondary measurements, which looked at blood sugar rises after a test meal, the LY900014 group had a reported 1-hour post-meal blood sugar rise of 63.1 mg/dL compared to 74.9 mg/dL in the insulin lispro group, and a 2-hour post-meal rise of 80.4 mg/dL compared to 97.8 mg/dL. Regarding low blood sugar (hypoglycaemia) episodes, the reported rate of severe episodes was 2.44 per 100 participant-years for LY900014 and 4.19 for insulin lispro. The rate of documented symptomatic low blood sugar episodes was reported as 2.21 events per participant per 30 days for LY900014 and 1.34 for insulin lispro. A separate blood marker called 1,5-AG, which also reflects blood sugar control, showed a reported increase of 1.99 mg/L for LY900014 and 2.15 mg/L for insulin lispro over the 26-week 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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NCT03109951 · results posted 20 March 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 187 participants, all of whom had diabetes. All 187 completed the study with no dropouts. The trial was looking at what happens to blood sugar levels in people with diabetes when they go through the bowel-cleansing preparation process required before a colonoscopy (a procedure to examine the large bowel). Specifically, it was measuring how many participants experienced blood sugar readings that fell outside a defined "normal" range — either too low (below 70 mg/dL) or too high (above 250 mg/dL) during that preparation period. The reported data shows that out of 187 participants, 2 had blood sugar levels recorded as too low, and 0 had blood sugar levels recorded as too high. The remaining 185 participants had blood sugar levels that stayed within the defined range throughout the preparation process. For the secondary outcomes, the reported data shows that 96 participants were aware of the symptoms of low blood sugar and said they could recognise them, based on a questionnaire. Additionally, 4 participants reported that they treated their own low blood sugar symptoms and found that the symptoms eased as a result. It is worth noting that the reported data does not include a breakdown of which specific measurements corresponded to which subgroups within the primary outcome — the three figures (2, 0, and 185) appear to represent the "too low," "too high," and "within range" counts respectively, based on the study description, but full labelling was not 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03078478 · results posted 12 March 2020
According to the results reported on ClinicalTrials.gov, this trial compared two long-acting insulins — Insulin Degludec U200 and Insulin Glargine U300 — in people with diabetes. A total of 805 people were assigned to the Insulin Degludec U200 group and 804 to the Insulin Glargine U300 group, making roughly 1,609 participants in all. The trial ran for up to 88 weeks and was primarily measuring how often participants experienced low blood sugar episodes (called hypoglycaemia — when blood sugar drops to a level that causes symptoms) during the final 36-week period of the study. The reported data shows that during that final 36-week period, the rate of low blood sugar episodes with symptoms was 216.8 per 100 patient-years for the Insulin Degludec U200 group, compared with 243.9 per 100 patient-years for the Insulin Glargine U300 group. (A "patient-year" is simply a way of accounting for how long all participants were in the study.) For low blood sugar episodes occurring overnight (between midnight and 5:59 am), the reported rates were 62.30 versus 93.75 per 100 patient-years respectively. The rate of the most serious (severe) low blood sugar episodes was reported as 0.98 versus 4.88 per 100 patient-years. On blood sugar control, the reported data shows that a measure called HbA1c — a way of tracking average blood sugar levels over roughly three months — changed by −0.54 percentage points in the Degludec group and −0.46 percentage points in the Glargine group from the start to the end of the trial. Fasting blood sugar levels (measured after not eating overnight) fell by an average of 35.50 mg/dL in the Degludec group and 25.68 mg/dL in the Glargine group. The average daily insulin doses at the end of the trial were reported as 66.6 units for the Degludec group and 73.0 units for the Glargine 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 ↗ · Linked publication on PubMed ↗
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NCT02607865 · results posted 27 February 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,864 people across four groups. Each group took a different daily oral tablet: one of three doses of oral semaglutide (3 mg, 7 mg, or 14 mg) or a comparison tablet called sitagliptin (100 mg). The trial ran for 78 weeks (roughly a year and a half) and was primarily measuring changes in a blood marker called HbA1c — a measure of average blood sugar levels over the previous few months. It also tracked changes in body weight and fasting blood sugar (a blood sugar reading taken before eating). The reported data shows that after 26 weeks, average HbA1c levels had fallen by 0.6 percentage points in the 3 mg semaglutide group, 1.1 points in the 7 mg group, 1.3 points in the 14 mg group, and 0.8 points in the sitagliptin group. For body weight at 26 weeks, the reported average reductions were 1.2 kg, 2.2 kg, 3.1 kg, and 0.6 kg respectively. At 78 weeks, the reported HbA1c reductions were 0.6, 0.9, 1.1, and 0.7 percentage points, and body weight reductions were 1.8 kg, 2.8 kg, 3.2 kg, and 1.0 kg. Fasting blood sugar also showed reductions across all groups at each time point, with the 14 mg semaglutide group consistently showing the largest reported drops. 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 ↗
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NCT02827708 · results posted 17 February 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02827708) enrolled 324 people in total — 163 received a 14 mg oral semaglutide tablet daily and 161 received a placebo (a dummy tablet with no active ingredient). The vast majority completed the 26-week study: 158 in the semaglutide group and 156 in the placebo group. The main thing being measured was the change in HbA1c — a blood test result (reported as a percentage) that reflects average blood sugar levels over the previous two to three months. Several secondary measurements were also tracked, including body weight, waist circumference, and a fasting blood sugar reading (called fasting plasma glucose). The reported data shows that, after 26 weeks, the HbA1c percentage in the oral semaglutide group fell by around 1.1 percentage points on average, compared with a fall of about 0.2 percentage points in the placebo group. For body weight, the semaglutide group recorded an average reduction of approximately 3.5 kg (roughly 3.75%), while the placebo group recorded an average reduction of about 0.9 kg (roughly 0.92%). The reported data also shows that fasting blood sugar levels fell by an average of 1.58 mmol/L in the semaglutide group compared with 0.34 mmol/L in the placebo group. Waist circumference decreased by an average of 2.8 cm in the semaglutide group versus 0.7 cm in the placebo group, and BMI (a measure comparing weight to height) fell by an average of 1.2 kg/m² versus 0.3 kg/m². 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 ↗
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NCT01243424 · results posted 7 January 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 3,028 people in the linagliptin group and 3,014 in the glimepiride group — both medications used to manage blood sugar in people with type 2 diabetes. The trial was measuring serious heart and blood vessel events (such as heart attacks, strokes, and cardiovascular-related deaths), as well as a broader measure of how well participants sustained their treatment over time (staying on their medication, keeping blood sugar in a target range, avoiding significant weight gain, and avoiding serious low blood sugar episodes). The reported data shows that for the main outcome — the rate of major cardiovascular events (heart attack, stroke, or cardiovascular death) — the linagliptin group had 20.7 events per 1,000 patient-years, compared with 21.2 in the glimepiride group. A broader measure that also included hospitalisations for chest pain returned 23.4 events per 1,000 patient-years for linagliptin and 23.7 for glimepiride. When expressed as the percentage of participants who experienced at least one such event, the reported figures were 11.8% (linagliptin) versus 12.0% (glimepiride) for the main measure, and 13.2% versus 13.3% for the broader measure. The reported data also shows that for the treatment sustainability measure — which combined staying on the medication, controlled blood sugar, no significant weight gain, and no serious low blood sugar episodes — 16.0% of participants in the linagliptin group met all those criteria, compared with 10.2% in the glimepiride group. When the low blood sugar condition was removed from that combined measure, the figures were 17.4% and 14.1% 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 ↗
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NCT03018028 · results posted 30 December 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 243 adults across five groups. Participants were randomly assigned to one of three doses of an oral (tablet) form of semaglutide (3 mg, 7 mg, or 14 mg), an injectable comparison medicine called liraglutide (0.9 mg), or a placebo (a dummy treatment with no active ingredient). The trial ran for 52 weeks and was primarily measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly three months — with the main result recorded at 26 weeks. The reported data shows that at 26 weeks, average HbA1c fell by 1.1 percentage points in the oral semaglutide 3 mg group, 1.7 percentage points in both the 7 mg and 14 mg groups, and 1.4 percentage points in the liraglutide group, compared with 0.2 percentage points in the placebo group. At 52 weeks, the reported changes were −1.0, −1.4, and −1.5 percentage points for the three oral semaglutide doses respectively, −1.3 for liraglutide, and +0.1 for placebo. For body weight, the reported data shows average changes at 26 weeks of −0.4 kg, −1.2 kg, and −2.4 kg for the three oral semaglutide doses, +0.1 kg for liraglutide, and −1.1 kg for placebo. The trial also measured fasting blood sugar and blood sugar readings taken at seven time points across the day; those figures followed broadly similar patterns across the groups, with the largest reported reductions generally seen in the oral semaglutide 14 mg and liraglutide groups compared with 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02592421 · results posted 18 December 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total — 20 received a medicine called dapagliflozin and 10 received a placebo (a dummy treatment with no active ingredient). All 30 participants completed every phase of the study. The trial was designed to measure how dapagliflozin affected blood sugar levels and the body's own production of glucose (sugar made internally by the liver and other organs), under three different conditions: a standard study setting, a "glucose clamp" (where blood sugar is held steady using a controlled infusion), and a "pancreatic clamp" (where hormones from the pancreas are also held steady). The reported data shows the following changes in blood sugar levels from the start of the study to the final hour. In the standard study setting, the dapagliflozin group had an average drop of 29.7 mg/dl, compared with 17.2 mg/dl in the placebo group. Under glucose clamp conditions, the dapagliflozin group showed a small rise of 3.1 mg/dl versus 0.9 mg/dl in the placebo group. Under pancreatic clamp conditions, the dapagliflozin group showed a drop of 30.3 mg/dl, compared with 2.3 mg/dl in the placebo group. For the body's internal glucose production, the reported data shows that across all three conditions, both groups showed various small changes — for example, in the standard setting the dapagliflozin group showed a change of +0.1 mg/kg.min versus −0.56 mg/kg.min in the placebo group. The trial also measured changes in insulin and glucagon (a hormone that raises blood sugar) levels during the study; these showed small numerical differences between the two groups across the three conditions, as 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00788827 · results posted 18 November 2019
According to the results reported on ClinicalTrials.gov, this trial involved 7 participants who all received a treatment involving their own stem cells (called "autologous CD34+ stem cells" — meaning stem cells collected from the participants themselves). Five of the seven participants completed the trial, while two did not finish. The trial was measuring safety and several blood test results before and after the stem cell infusion, including blood sugar control, insulin use, and kidney and pancreas-related markers. The reported data shows that 1 out of 7 participants experienced an adverse event (an unwanted or unexpected health event) that was considered related to the treatment, while all 7 participants experienced at least one adverse event of any kind across the study period. For the blood test measurements, the reported data shows average HbA1c (a measure of blood sugar levels over time) was 7.2% before the infusion and 7.24% after. Average daily insulin use went from 59.4 units per day before the infusion to 54.06 units per day after. Average amylase levels (a marker linked to the pancreas) went from 48.49 units/L before to 75.52 units/L after. Average serum creatinine (a marker linked to kidney function) went from 128.22 umol/L before to 118.64 umol/L after. It is worth noting that this was a very small trial with only 7 participants, which limits how broadly the numbers can be interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03021187 · results posted 7 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT03021187) enrolled 731 adults across four groups: three groups received different daily doses of an oral form of semaglutide (3 mg, 7 mg, or 14 mg), and one group received a placebo (a dummy pill with no active ingredient). The trial ran for 52 weeks and was primarily measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly three months — from the start of the trial to the 26-week mark. Body weight, fasting blood sugar, and blood sugar readings taken at seven points throughout the day were also tracked. The vast majority of participants — between 173 and 175 in each group — completed the trial. The reported data shows that at 26 weeks, average HbA1c levels had changed by −0.5 percentage points in the 3 mg group, −1.0 in the 7 mg group, −1.3 in the 14 mg group, and −0.1 in the placebo group. At 52 weeks, those figures were −0.6, −0.9, −1.2, and −0.2 respectively. For body weight, the reported data shows average changes at 26 weeks of −1.4 kg (3 mg), −2.6 kg (7 mg), −3.7 kg (14 mg), and −0.5 kg (placebo); at 52 weeks these were −0.9 kg, −2.2 kg, −3.8 kg, and +0.5 kg respectively. Fasting blood sugar and the seven-point daily blood sugar readings also showed reported reductions across the semaglutide groups at both 26 and 52 weeks, with the largest reported changes generally seen in the 14 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02565706 · results posted 30 October 2019
According to the results reported on ClinicalTrials.gov, this trial involved four groups of participants across two related sub-studies. In total, 744 people were enrolled — 178, 172, 193, and 201 across the four groups respectively. The trial was looking at a program called "WIC Fresh Start" compared with existing online health education, and was measuring things like how often and how much fruit and vegetables participants ate, whether they used special vouchers (called FMNP vouchers) that could be spent at farmers' markets, and how much they knew about those voucher programs. Not everyone finished the study — across the four groups, between 90 and 116 people completed it out of those who started. The reported data shows that, for fruit and vegetable intake, participants across all groups reported eating fruits and vegetables roughly 3.3 to 4.0 times per day at various points during the study, and consuming approximately 4.4 to 4.9 cups per day — with the numbers shifting somewhat across the different time points measured. For voucher use (in the sub-groups that received FMNP vouchers), 84 participants in the WIC Fresh Start group and 77 in the comparison group redeemed their farmers' market vouchers. Far fewer used a separate "cash value voucher" at farmers' markets specifically — 7 in the WIC Fresh Start group and 1 in the comparison group. On a knowledge quiz about the farmers' market voucher program (scored 0–6, where higher means more knowledge), scores across groups ranged from roughly 4.4 to 5.1 across the different time points and groups. Some additional figures were reported as odds ratios — a way of comparing the likelihood of an outcome between groups — but the reported data shows these varied across time points and groups, and further detail was not fully reported for all sub-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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01394952 · results posted 8 October 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01394952) enrolled just under 10,000 people in total — 4,952 in the placebo group and 4,949 in the dulaglutide group — all of whom had type 2 diabetes. The trial was measuring how often serious heart and blood vessel events occurred, specifically tracking whether participants experienced a heart attack, stroke, or death from a cardiovascular (heart/blood vessel) cause. It also tracked a range of secondary outcomes, including deaths from any cause, kidney and eye complications, heart failure leading to hospitalisation, and hospitalisations for unstable chest pain (angina). The reported data shows that for the main (primary) outcome — the number of people who had their first heart attack, stroke, or cardiovascular death — 663 people in the placebo group experienced one of these events, compared with 594 in the dulaglutide group. Looking at those events individually as secondary outcomes, the reported numbers for cardiovascular death were 346 (placebo) versus 317 (dulaglutide); for non-fatal heart attack, 212 versus 205; and for non-fatal stroke, 175 versus 135. For deaths from any cause, 592 people in the placebo group died compared with 536 in the dulaglutide group. The reported data also shows that for the combined kidney and eye complication outcome, 1,241 placebo participants experienced an event versus 1,099 in the dulaglutide group. For heart failure requiring hospitalisation or an urgent clinic visit, the numbers were 226 versus 213. For hospitalisation due to unstable angina, 77 placebo participants experienced an event compared with 88 in the dulaglutide 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 ↗ · Linked publication on PubMed ↗
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NCT01232946 · results posted 7 August 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people across three groups: 9 received liraglutide (a type 2 diabetes medicine), 10 received insulin detemir (a long-acting insulin), and 11 received a combination of both. By the end of the three-month study, 27 participants completed it — one person in the insulin detemir group and two in the combination group did not finish. The trial was measuring how the heart muscle uses energy — specifically how much glucose (sugar) and fatty acids (fats) the heart takes up and processes — using a specialised imaging scan called a PET scan. The reported data shows the following measurements of heart energy use after three months. For glucose uptake by the heart muscle, the liraglutide group recorded 0.055 units, the insulin detemir group recorded 0.040 units, and the combination group recorded 0.037 units (all in micromoles per gram per minute — a measure of how much fuel the heart is taking in). For the rate at which the heart burned fatty acids as fuel, the figures were 0.102 for liraglutide, 0.123 for insulin detemir, and 0.099 for the combination group. For the rate at which fatty acids were stored rather than burned, the reported figures were 0.00274 for liraglutide, 0.00358 for insulin detemir, and 0.00146 for the combination group. No further breakdown or comparison statistics were 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02971202 · results posted 1 August 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled three groups of participants: 12 people with type 1 diabetes (T1DM), 10 people with a specific inherited form of diabetes called MODY2, and 11 healthy controls (people without diabetes). Each group underwent a procedure called a "hyperinsulinemic euglycemic clamp" — a research technique where insulin and glucose are carefully controlled through a drip so that researchers can measure how the body responds to insulin under controlled conditions. Across all three groups, 10 people in each group completed the study. The reported data shows the following for the main outcome — how much glucose the whole body used during peak insulin stimulation (measured in milligrams per kilogram of lean body mass per minute): the T1DM group recorded 8.5, the MODY2 group recorded 11.0, and the healthy control group recorded 12.1. For the first secondary measure — how well the liver reduced its glucose output in response to insulin — the reported figures were 1.9 for T1DM, 2.1 for MODY2, and 1.7 for controls. For the second secondary measure — how well fat tissue responded to insulin, judged by levels of a fat-related substance in the blood called non-esterified fatty acids (NEFAs, a marker of fat breakdown) — the reported levels at a set time point were 122.4 micromoles per litre in the T1DM group, 382.3 in the MODY2 group, and 392.7 in the 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03092752 · results posted 5 July 2019
According to the results reported on ClinicalTrials.gov, this trial looked at prescription records for oral diabetes medicines (called oral antidiabetic drugs, or OADs) in Japan between January 2014 and September 2016. It was an observational study — meaning researchers reviewed existing medical records rather than giving people a new treatment — and it focused on how often six different classes of these medicines were prescribed to people with type 2 diabetes, and whether kidney health (measured using a calculation called eGFR, which estimates how well the kidneys are filtering blood) appeared to influence which medicine was chosen. In total, 523,585 patient records were started in the analysis, of which 162,116 were counted as completing the study's review process. The reported data shows that across the study period, the most commonly prescribed medicine class was DPP4 inhibitors (a group of diabetes tablets), with 91,634 prescriptions recorded. This was followed by biguanides (33,238), sulfonylureas (28,211), alpha-glucosidase inhibitors (26,192), glinides (16,787), and thiazolidinediones (10,344). The reported data also shows that the average age of patients receiving prescriptions ranged from about 66.5 years (biguanide group) to about 72 years (sulfonylurea group), and the average kidney function score (eGFR) across all groups was reported as 65.2, with individual medicine groups ranging from about 59.5 to 74. When prescriptions were broken down by kidney health stage, the reported numbers varied noticeably across the different stages, suggesting the kidney function category was recorded alongside each prescription, though the full breakdown figures were only partially reported 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.
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NCT02547935 · results posted 4 June 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 448 people across three groups: one group took a combination of two medicines (dapagliflozin 10 mg plus saxagliptin 2.5 mg), a second group took dapagliflozin 10 mg on its own, and a third group took a placebo (a dummy pill with no active medicine). The trial ran for 24 weeks and measured two main things: changes in a blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over roughly three months), and changes in a urine test called the urine albumin-to-creatinine ratio, or UACR (a measure of how much of a protein called albumin is leaking into the urine, which can signal stress on the kidneys). The reported data shows the following for the two main measures at 24 weeks. For HbA1c, the combination group's average result fell by 0.85 percentage points from where it started, compared with a fall of 0.27 percentage points in the placebo group. For UACR, the combination group showed an average reduction of about 39%, the dapagliflozin-alone group showed about 22%, and the placebo group showed about 2%. On the secondary measures, the reported data shows that body weight changed by around −0.65% in the combination group, −1.48% in the dapagliflozin-alone group, and −0.61% in the placebo group. Fasting blood sugar levels fell by an average of 17.2 units (mg/dL) in the combination group, 13.1 in the dapagliflozin-alone group, and 11.2 in the placebo group. When looking at how many individuals hit certain targets, 57% of the combination group, 45% of the dapagliflozin-alone group, and 31% of the placebo group achieved at least a 30% reduction in UACR. For HbA1c dropping below 7%, the figures were 35% in the combination group, 15% in the dapagliflozin-alone group, and 10% 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01793909 · results posted 20 May 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01793909) enrolled 55 people in total — 30 with type 2 diabetes and 25 who were overweight but did not have diabetes. The trial was measuring how muscles use oxygen during exercise, specifically looking at a process called muscle oxygen saturation (how much oxygen the muscle is drawing out of the blood) during a leg exercise. The idea was to understand whether any differences seen in people with type 2 diabetes were mainly due to how oxygen is delivered to the muscles, or how the muscles use it. Not everyone finished the study — 20 people from each group completed it, meaning 10 people with type 2 diabetes and 5 overweight controls did not finish. The reported data shows that muscle oxygen saturation was measured before and after an exercise programme for both groups. Oxygen saturation is expressed as a percentage, and a negative number here means the muscle was drawing oxygen out of the blood (a normal response to exercise). Before the exercise programme, the reported figure for the type 2 diabetes group was −10.7%, compared with −8.9% for the overweight control group. After the exercise programme, the type 2 diabetes group's figure was reported as −12.5%, while the overweight control group's figure was −8.8%. The reported data shows these were the key numbers collected, though further detail on what these changes mean in context was not included in the structured results 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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NCT02597127 · results posted 17 May 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02597127) enrolled 501 adults across eight groups to test different doses of a medicine called inclisiran — given either as a single injection or as two injections — compared to a dummy injection (placebo). The trial was measuring changes in LDL cholesterol (often called "bad" cholesterol) in the blood over time, with the main focus on how much LDL cholesterol levels changed between the start of the trial and day 180 (roughly six months later). The reported data shows that, at day 180, participants who received the placebo (dummy injection) had LDL cholesterol levels that were roughly the same as when they started (a change of about +2% for the single-dose placebo group and +1.8% for the double-dose placebo group). By contrast, those who received inclisiran had lower LDL cholesterol levels at day 180, with the reported percentage reductions ranging from about 28% (single-dose 200 mg group) up to about 53% (double-dose 300 mg group). Looking at an earlier timepoint — day 90 — the reported reductions were also notable across the inclisiran groups, ranging from around 34% to 50%, while the placebo groups showed less than a 1% change. The reported data also shows that, at day 180, no participants in the highest-dose groups (single-dose 500 mg or double-dose 300 mg) had LDL cholesterol levels that had returned to within 80% of their starting level, compared to 35 out of 60 in the single-dose placebo group and 29 out of 62 in the double-dose placebo group. Additionally, the number of participants who achieved a 50% or greater reduction in LDL cholesterol by day 180 ranged from 9 to 32 across the inclisiran groups, compared to zero in either 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 ↗ · Linked publication on PubMed ↗
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NCT02299388 · results posted 8 May 2019
According to the results reported on ClinicalTrials.gov, this was a small clinical trial involving 11 people with type 2 diabetes. Six participants were assigned to receive a medicine called liraglutide, and five were assigned to receive a placebo (a dummy treatment with no active ingredient). All six people in the liraglutide group completed the trial, while four out of five in the placebo group completed it. The trial ran for eight weeks and was primarily measuring changes in blood pressure — specifically systolic blood pressure (the "top number" in a blood pressure reading), tracked continuously using a wearable blood pressure monitor worn throughout the day. The reported data shows that, on average, systolic blood pressure fell by around 4.9 mm Hg (millimetres of mercury, the standard unit for measuring blood pressure) in the liraglutide group, and by around 5.5 mm Hg in the placebo group, over the eight weeks. For the secondary measurements — which looked at other aspects of blood pressure including diastolic pressure (the "bottom number"), mean arterial pressure (an average pressure across the heartbeat cycle), pulse pressure (the gap between the top and bottom numbers), and nocturnal (overnight) blood pressure — the reported data shows a range of small changes in both directions across the two groups. The figures for these secondary measures varied, and no results were reported for several other pre-specified outcomes relating to blood vessel function, heart rate patterns, and hormone levels. It is worth noting that this was a very small trial, and the results as reported on ClinicalTrials.gov simply describe the numbers recorded — they do not on their own confirm whether any change was caused by the 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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NCT01200394 · results posted 12 March 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 256 participants in total — 64 received a placebo (an inactive dummy treatment) and 192 received a drug called PF-00489791 at a dose of 20 mg. Of those who started, 62 placebo participants and 164 in the drug group completed the trial. The trial was primarily measuring changes in a urine test called the Urinary Albumin Creatinine Ratio (UACR) — a way of checking how much of a protein called albumin is leaking into the urine, which can be a sign of kidney stress. A range of other kidney and blood pressure measurements were also tracked over 16 weeks. The reported data shows that, at the start of the trial, the average UACR was around 195 mg/mmol in the placebo group and 183 mg/mmol in the drug group. By week 12 — the main measurement point — the placebo group's UACR had on average risen by about 9 mg/mmol from their starting level, while the drug group's UACR had on average fallen by about 7 mg/mmol from their starting level. For the secondary urine protein measure (UPCR), a similar general pattern was reported across the different time points. The reported data shows that estimated kidney filtration rates (a measure of how well the kidneys are filtering blood) were similar in both groups at the start and changed only slightly in both groups across all time points. Blood pressure readings and blood creatinine levels (another kidney marker) were also reported at multiple time points, with the numbers in both groups remaining broadly comparable throughout 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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NCT01868646 · results posted 4 March 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01868646) enrolled 148 people with type 2 diabetes — 76 in the Subetta group and 72 in the placebo group. Most participants completed the trial (73 in the Subetta group and 67 in the placebo group). The trial was measuring changes in blood sugar control over time, using several different tests including HbA1c (a blood test that reflects average blood sugar levels over roughly three months), fasting blood glucose (blood sugar after an overnight fast), and self-monitored blood glucose readings taken at seven points across the day. The reported data shows that, for the primary measure — change in HbA1c — the Subetta group's average HbA1c fell by around 0.53–0.54 percentage points across different time points, while the placebo group's figures ranged from a small fall of 0.01–0.07 to a small rise of 0.15 percentage points. For fasting plasma glucose, the Subetta group's reported change was around 0.0 to −0.5 mmol/L depending on the time point, while the placebo group showed changes ranging from −0.1 to +1.0 mmol/L. For the seven-point self-monitored daily blood glucose, both groups showed small falls across the various time points, mostly in the range of −0.2 to −0.5 mmol/L for both groups. For basal insulin dose (the background insulin taken daily), the Subetta group's average dose changed by −0.9 IU/day while the placebo group's average dose changed by +3.5 IU/day. Changes in C-peptide (a marker related to the body's own insulin production) and blood fats (cholesterol and triglycerides) were also reported, with relatively small numerical differences between the two groups across the various 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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NCT02049814 · results posted 4 February 2019
According to the results reported on ClinicalTrials.gov, this trial compared two combination treatments for people with type 2 diabetes: metformin taken together with voglibose (0.2 mg), versus metformin taken together with acarbose (50 mg). A total of 248 people were assigned to the voglibose combination and 246 to the acarbose combination, with 219 in each group completing the full 12-week study. The trial was mainly measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly three months, expressed as a percentage — as well as blood sugar levels before and after meals, and insulin levels. The reported data shows that, for the main outcome at 12 weeks, the HbA1c percentage fell by an average of approximately 0.70 percentage points in the metformin-plus-voglibose group, and by approximately 0.93 percentage points in the metformin-plus-acarbose group, both measured from where participants started. At the six-week midpoint, the reported falls were approximately 0.48 and 0.63 percentage points respectively. For fasting blood sugar (measured before eating), the reported data shows average reductions of around 0.42–0.50 mmol/L in the voglibose group and 0.80–0.89 mmol/L in the acarbose group across the two time points. Blood sugar measured after meals also showed reductions in both groups across the time points recorded, ranging roughly from 2.1 to 2.7 mmol/L in the voglibose group and 2.1 to 4.0 mmol/L in the acarbose group. For insulin levels, the reported data shows that fasting insulin changed by a very small average amount (+0.03 μU/dL) in the voglibose group and by approximately +2.42 μU/dL in the acarbose group at week 12. Insulin measured after meals showed varied changes across both groups and time points. It is worth noting that some of the after-meal insulin figures had multiple measurements reported (one and two hours post-meal), and the exact pairing of individual numbers to specific time points was not fully distinguishable 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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NCT01736865 · results posted 11 January 2019
According to the results reported on ClinicalTrials.gov, this trial involved 127 people in total — 61 in the placebo group and 66 in the cholecalciferol (vitamin D) group. All participants completed the study with no dropouts recorded. The trial was measuring how well the pancreas responds to blood sugar — specifically, whether it releases enough insulin to keep blood glucose under control. It also looked at whether participants' blood sugar categories changed over the course of the study. The reported data shows that for the main measurement — a score called the Disposition Index (which reflects how well the pancreas secretes insulin in response to blood sugar) — the placebo group had a reported value of 0.023, while the vitamin D group had a reported value of 0.149. For the secondary outcome, which counted how many participants either reduced their diabetes medications or lowered their HbA1c (a measure of average blood sugar over several months) by a meaningful amount without increasing medications, the reported data shows 53 out of 61 participants in the placebo group and 52 out of 66 in the vitamin D group met this combined measure. The reported data also shows that average HbA1c changed by 0.2 percentage points in both groups. For blood vitamin D levels, the placebo group averaged 27.5 ng/mL and the vitamin D group averaged 25.8 ng/mL — though data for some other pre-specified outcomes 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.
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NCT01989754 · results posted 11 December 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01989754) enrolled 5,812 people in total — 2,905 in the placebo group and 2,907 in the canagliflozin group. The vast majority completed the study (around 2,866 and 2,872 in each group respectively). The trial was measuring kidney-related and heart-related outcomes in people with type 2 diabetes, specifically looking at whether their levels of a protein called albumin in the urine worsened over time, and whether they experienced heart-related deaths or hospital admissions for heart failure. The reported data shows the following numbers for the primary outcome — worsening of albumin in the urine (a marker of kidney stress). In the placebo group, there were approximately 153 such events per 1,000 patient-years (a way of counting events that accounts for how long people were followed), compared with approximately 100 events per 1,000 patient-years in the canagliflozin group. For the secondary outcomes, the combined rate of cardiovascular (heart-related) death or hospitalisation for heart failure was reported as about 21.9 events per 1,000 patient-years in the placebo group versus about 15.9 in the canagliflozin group. For cardiovascular death alone, the reported rates were about 11.6 per 1,000 patient-years in the placebo group and about 10.1 per 1,000 patient-years in the canagliflozin group. These figures are event rates as counted and submitted by the trial's sponsor, and no further statistical detail (such as confidence intervals or p-values) was 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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NCT02630706 · results posted 7 December 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 506 adults across three groups: 170 people received ertugliflozin 5 mg, 169 received ertugliflozin 15 mg, and 167 received a placebo (a dummy pill with no active ingredient). The trial ran for 26 weeks and was measuring changes in a blood marker called A1C — a measure of average blood sugar levels over roughly three months — as well as tracking how many participants experienced any unwanted medical events (called adverse events) during the study. Most participants completed the trial: 163, 160, and 157 in each group respectively. The reported data shows that, on average, A1C levels changed from the start of the trial to week 26 as follows: the ertugliflozin 5 mg group saw a reduction of 1.00 percentage point, the ertugliflozin 15 mg group saw a reduction of 0.89 percentage points, and the placebo group saw a reduction of 0.20 percentage points. These figures exclude data from participants who needed additional blood sugar medication during the trial. A separate analysis looking only at participants from China showed similar figures: reductions of 1.01, 0.92, and 0.24 percentage points for the 5 mg, 15 mg, and placebo groups respectively. The reported data also shows that adverse events (any unwanted medical sign, symptom, or lab finding during the study, whether or not linked to the treatment) were recorded in 56.5% of the 5 mg group, 53.3% of the 15 mg group, and 59.3% of the placebo group. Among those in the China subgroup, the figures were 54.4%, 50.4%, and 59.3% respectively. The proportion of participants who stopped taking their study treatment because of an adverse event was small across all groups: 1.2% (5 mg), 0.6% (15 mg), and 1.8% (placebo) overall, and 0.7%, 0.7%, and 2.2% in the China subgroup. 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 ↗
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NCT01144338 · results posted 8 August 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01144338) involved over 14,700 people in total — roughly 7,396 received a placebo (an inactive treatment) and 7,356 received a once-weekly injection called exenatide. The trial was measuring whether exenatide, compared to placebo, affected the rate of serious heart and stroke-related events in participants. The main outcome being tracked was a combined measure of three serious events: death from a cardiovascular (heart or blood vessel) cause, a non-fatal heart attack, or a non-fatal stroke. The reported data shows that, for this main combined outcome, 905 people in the placebo group and 839 people in the exenatide group experienced one of those three events during the trial. Looking at the individual components, the reported data shows 383 cardiovascular deaths in the placebo group compared to 340 in the exenatide group; 493 heart attacks (fatal or non-fatal) in the placebo group compared to 483 in the exenatide group; and 218 strokes (fatal or non-fatal) in the placebo group compared to 187 in the exenatide group. For deaths from any cause, 584 were recorded in the placebo group and 507 in the exenatide group. These numbers are simply counts of how many participants experienced each event — the reported data does not allow us to draw conclusions about cause and effect from these figures alone, and no further statistical detail (such as whether any differences were considered meaningful by the researchers) was included in the structured data 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02182830 · results posted 31 July 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02182830) enrolled 166 people in total — 83 in a placebo group and 83 in a group receiving empagliflozin (a tablet tested at 10 mg, later increased to 25 mg). The trial was measuring changes in blood sugar control (using a marker called HbA1c — a percentage that reflects average blood sugar over roughly three months), blood pressure, and body weight over a period of 24 weeks. Of those who started, 68 people in each group completed the full study. The reported data shows the following adjusted average changes from the starting point. For blood sugar (HbA1c) at 24 weeks, the placebo group showed a small increase of 0.07 percentage points, while the empagliflozin group showed a decrease of 0.71 percentage points. For 24-hour ambulatory (measured while going about daily life) systolic blood pressure (the "top" number in a blood pressure reading) at 12 weeks, the placebo group averaged a drop of 0.90 mmHg, compared with a drop of 6.10 mmHg in the empagliflozin group; at 24 weeks those figures were –1.94 mmHg versus –10.33 mmHg respectively. A similar pattern was seen for seated and trough (lowest point of the day) blood pressure readings. For body weight at 24 weeks, the placebo group averaged a loss of 0.98 kg, while the empagliflozin group averaged a loss of 2.21 kg. These figures are adjusted averages across the groups as a whole and reflect what was recorded during this particular trial under its specific 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01676116 · results posted 9 July 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01676116) enrolled 438 adults with type 2 diabetes — 292 in one group and 146 in the other. The trial ran for 26 weeks and compared two different injectable diabetes medication approaches, both used alongside other diabetes tablets (oral anti-diabetic drugs). One group received a combination injection of insulin degludec and liraglutide, while the other received either liraglutide or exenatide on its own. The main thing being measured was a blood marker called HbA1c — a percentage that reflects average blood sugar levels over roughly three months. Several other things were also tracked, including body weight, fasting blood sugar, and episodes of low blood sugar (hypoglycaemia). The reported data shows that, on average, HbA1c fell by 1.32 percentage points in the combination injection group and by 0.37 percentage points in the liraglutide/exenatide group. When looking at how many people reached a commonly used HbA1c target of below 7.0%, the reported figures were 75.3% of participants in the combination group and 35.6% in the comparison group. For a slightly lower target of 6.5% or below, the reported figures were 63% and 22.6% respectively. The reported data also shows that average body weight went up by 2 kg in the combination group and fell by 0.8 kg in the comparison group. Fasting blood sugar dropped by an average of 2.98 mmol/L in the combination group and 0.6 mmol/L in the comparison group. The reported data shows that low blood sugar episodes (confirmed hypoglycaemia, meaning either severe or minor) occurred at a rate of 281.7 events per 100 patient-years in the combination injection group, compared with 12.1 events per 100 patient-years in the liraglutide/exenatide group. (Patient-years is simply a way of accounting for how long all participants were in 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02240680 · results posted 3 July 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02240680) looked at a medicine called linagliptin (5 mg) compared to a placebo (a dummy tablet with no active ingredient) in people with type 2 diabetes. The main thing being measured was a blood marker called HbA1c — a percentage that reflects average blood sugar levels over roughly three months, where a higher number generally means blood sugar has been less well controlled. In the first part of the trial (up to 24 weeks), 151 people were assigned to placebo and 151 to linagliptin. A separate group of Japanese participants (50 on placebo, 52 on linagliptin) continued for up to 52 weeks. The reported data shows that, after 24 weeks, the placebo group's HbA1c level fell by an average of 0.38 percentage points from where it started, while the linagliptin group's fell by an average of 1.01 percentage points. For fasting blood sugar (a single blood sugar reading taken after not eating overnight, measured in milligrams per decilitre), the placebo group saw an average change of +0.2 and the linagliptin group saw an average change of −11.3. The reported data also shows that after 24 weeks, about 70% of people in the linagliptin group had an HbA1c below 8%, compared with about 40% in the placebo group; and roughly 38% of the linagliptin group had an HbA1c below 7%, compared with about 15% in the placebo group. Regarding low blood sugar episodes (called hypoglycaemia — when blood sugar drops to a level that can cause symptoms or need assistance), the reported data shows that approximately 30.9% of people in the linagliptin group and 23.8% in the placebo group experienced at least one episode meeting the trial's definition. Using a stricter definition (blood sugar below 54 mg/dL), the figures were 16.8% for linagliptin and 15.0% for 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02505334 · results posted 25 June 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 233 participants in each of two groups — one group received a higher dose of liraglutide (1.8 mg) and the other received a lower dose (0.9 mg). The trial was primarily measuring changes in a blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over roughly three months) after 26 weeks of treatment. Only the higher-dose group continued into an extension period of up to 52 weeks; the lower-dose group did not take part in that extension. The reported data shows that after 26 weeks, the higher-dose (1.8 mg) group's HbA1c changed by an average of −0.23 percentage points from their starting level, while the lower-dose (0.9 mg) group's HbA1c changed by an average of +0.17 percentage points. For the secondary outcomes at 26 weeks, 53 participants in the higher-dose group and 18 in the lower-dose group reached an HbA1c below 7.0%; of those, 36 and 13 respectively did so without gaining weight. Fewer participants — 18 in the higher-dose group and 5 in the lower-dose group — reached the stricter target of 6.5% or below. At 52 weeks (higher-dose group only), 45 participants had an HbA1c below 7.0%, and 16 were at or below 6.5%. The reported data shows that the number of participants reaching HbA1c below 7.0% without a low blood sugar episode (hypoglycaemia) matched the overall below-7.0% responder counts at both time points, though full details for some secondary measures at 52 weeks were not reported for the lower-dose 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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NCT01027871 · results posted 8 June 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 289 people across three groups: 93 received insulin glargine (an existing basal insulin), 98 received a then-experimental insulin called LY2605541 using one dosing method (Algorithm 1), and 98 received the same experimental insulin using a different dosing method (Algorithm 2). The trial ran for 12 weeks and was primarily measuring participants' fasting blood glucose (the level of sugar in the blood after an overnight fast), along with several other blood sugar measures including a longer-term blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over roughly three months). The reported data shows that at 12 weeks, average fasting blood glucose levels were 6.83 mmol/L for the insulin glargine group, 7.15 mmol/L for LY2605541 Algorithm 1, and 6.84 mmol/L for LY2605541 Algorithm 2. For the secondary measures, when the two LY2605541 groups were combined, the reported average change in fasting blood glucose from the start of the trial was a decrease of 1.97 mmol/L, compared with a decrease of 1.77 mmol/L for insulin glargine. The average HbA1c percentage was reported to have fallen by 0.74 percentage points in the combined LY2605541 group and 0.64 percentage points in the insulin glargine group. Around 52% of participants in the combined LY2605541 group and 48% in the insulin glargine group reached an HbA1c below 7.0% by week 12, while around 30% and 23% respectively reached 6.5% or below. The reported data also noted what percentage of participants hit those HbA1c targets without experiencing a low blood sugar episode (hypoglycaemia — when blood sugar drops to a potentially concerning level): approximately 16% of the combined LY2605541 group and 12% of the insulin glargine group achieved below 7.0% HbA1c without a hypoglycaemic episode. 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 ↗
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NCT02642159 · results posted 1 May 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02642159) enrolled 413 people in total — 276 in the alirocumab group and 137 in the usual care group. The trial was measuring changes in certain types of cholesterol in the blood over 24 weeks. Specifically, it looked at "non-HDL cholesterol" (a measure of the types of cholesterol considered less desirable) and "LDL cholesterol" (often called "bad" cholesterol). A smaller sub-group of participants — 47 in the alirocumab group and 24 in the usual care group — were also planned to receive a separate cholesterol-lowering medicine called fenofibrate, and results for this sub-group were reported separately. The reported data shows that, for the main group of all participants at 24 weeks, the alirocumab group had an average reduction in non-HDL cholesterol of 37.3%, while the usual care group had an average reduction of 4.7%. For LDL cholesterol at 24 weeks, the alirocumab group showed an average reduction of 43.3%, compared with a reduction of 0.3% in the usual care group. At the earlier 12-week check, the reported non-HDL cholesterol reductions were 35.5% for the alirocumab group and 9.4% for the usual care group. In the smaller sub-group where fenofibrate was also planned, the reported data shows non-HDL cholesterol reductions of 41.7% (alirocumab) versus 8.5% (fenofibrate/usual care) at 24 weeks, and LDL cholesterol changes of a 47.0% reduction in the alirocumab group compared with an 8.7% *increase* in the fenofibrate/usual care sub-group at 24 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02526524 · results posted 27 April 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02526524) enrolled 571 adults across six groups to compare different doses of a delayed-release form of metformin (Met DR, taken once in the morning at doses of 600 mg, 900 mg, 1200 mg, or 1500 mg) against a placebo (a dummy treatment with no active ingredient) and a standard immediate-release form of metformin (Met IR, 2000 mg). The trial ran for 16 weeks. The number of people who completed the study varied by group: between 70 and 89 out of roughly 94–96 who started in each group finished the trial. The main thing being measured was the change in HbA1c — a blood test result (expressed as a percentage) that reflects average blood sugar levels over roughly two to three months. The reported data shows that, after 16 weeks, the average HbA1c reading fell by different amounts in each group. In the placebo group the average drop was 0.06 percentage points. In the delayed-release metformin groups, the reported average drops were 0.33 points (600 mg), 0.40 points (900 mg), 0.49 points (1200 mg), and 0.62 points (1500 mg). In the standard immediate-release metformin group, the reported average drop was 1.10 percentage points. No secondary outcome measure data was included 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 ↗
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NCT00130208 · results posted 23 March 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,056 people in total — 524 in the sulodexide (the treatment being tested) group and 532 in the placebo group. The trial was measuring whether sulodexide could reduce a protein called albumin leaking into the urine — a sign sometimes associated with kidney stress in people with diabetes. Specifically, it looked at whether participants could move from a mid-range level of albumin in the urine (called microalbuminuria) down to a normal level (called normoalbuminuria). The trial ran for 26 weeks of treatment followed by an 8-week washout (a period where participants stopped taking the treatment so researchers could observe what happened afterwards). The reported data shows that for the first primary outcome — the number of people who moved from the mid-range to the normal level of urine albumin AND had at least a 25% reduction in their albumin-to-creatinine ratio (a standard measurement used to track kidney protein loss) — 39 people in the sulodexide group and 30 people in the placebo group met this measure. For the second primary outcome — the number of people who achieved a 50% or greater reduction in urine albumin levels — the reported data shows 76 people in the sulodexide group and 87 people in the placebo group reached this mark. The reported data also shows one secondary (additional) outcome: the percentage change in albumin levels in the blood from the start of the trial to the end of the 26-week treatment period. Both groups showed a change of -0.02%, meaning the result was virtually identical between the sulodexide and placebo groups. Any other secondary outcome data was not reported in the 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00256867 · results posted 23 March 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 369 people across eight treatment groups. Participants were assigned to one of four doses of a fixed-dose combination (FDC) pill containing two medicines — rosiglitazone (RSG) and simvastatin (SIMV) — or to one of the individual medicines alone at various doses. The trial was measuring two main things: how much a type of cholesterol called LDL (often called "bad cholesterol") changed after 6 weeks, and how much a blood sugar marker called HbA1c (a measure of average blood sugar over roughly 3 months) changed after 16 weeks. Between 36 and 45 people in each group completed the study. The reported data shows that, for the primary measure — the percentage change in LDL cholesterol at 6 weeks — participants taking any of the FDC combination doses had a median (middle-point) reduction of about 39.9%, while those taking RSG alone saw a median increase of 5.4%. Looking at individual groups, the reported reductions in LDL ranged from about 32.7% to 44.4% across the FDC groups, and simvastatin-alone groups showed reductions of around 34.0% to 44.2%. For the blood sugar marker HbA1c at 16 weeks, the reported data shows the FDC groups had an average change of −0.83 mg/dL combined, while simvastatin alone showed almost no change (−0.01 mg/dL). The reported data also shows that 148 people in the combined FDC groups reached an LDL level below 100 mg/dL at week 6, compared with 20 people in the RSG-alone groups. For fasting blood sugar, the FDC groups and RSG-alone groups showed reductions, while simvastatin-alone groups showed a small increase. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02014740 · results posted 22 March 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02014740) enrolled 100 people in total — 55 in the liraglutide group and 45 in the metformin group. Of those, 49 and 40 participants respectively completed the study. The trial was measuring **epicardial fat thickness** — a layer of fat that sits around the heart and can be measured with an ultrasound scan. This measurement was used as a way to track changes in deeper body fat stores without needing more invasive procedures. The reported data shows epicardial fat thickness (measured in millimetres) at what appear to be three time points for each group, though the specific time points were not labelled in the submitted data. For the liraglutide group, the three recorded values were 9.6 mm, 6.8 mm, and 6.2 mm. For the metformin group, the corresponding values were 7.4 mm, 7.5 mm, and 6.9 mm. No additional breakdown or statistical detail was included in the submitted results, so further context around these numbers was not 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00372957 · results posted 19 March 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total — 10 in a placebo group, 10 receiving a 15 mg dose of the investigational drug GW823093C, and 10 receiving a 30 mg dose. All 30 participants completed the study with no drop-outs reported. The trial was primarily focused on **pharmacokinetics** — that is, tracking how the drug moved through the body by measuring its levels in the blood over time. No placebo group data was included in the pharmacokinetic measurements, as these measures only apply to participants who received the active drug. The reported data shows the following for the key blood-level measurements. The **peak drug concentration in the blood (Cmax)** was reported as approximately 238–263 ng/mL (nanograms per millilitre) for the 15 mg group, and approximately 420–535 ng/mL for the 30 mg group — meaning higher doses were associated with higher peak blood levels. The **time to reach that peak (Tmax)** was reported as roughly 2.5–3 hours for the 15 mg group and 2–3.5 hours for the 30 mg group. The **half-life** — meaning the time it took for the drug level in the blood to fall by half — was reported as approximately 6.7–7.1 hours for the 15 mg group and 8.8–9.6 hours for the 30 mg group. The **total drug exposure over time (AUC)**, a measure of how much drug the body was exposed to overall, was also reported as higher in the 30 mg group than the 15 mg group across all calculations used. No secondary outcome data appears to have been reported in the submitted results. The reported data covers only these pharmacokinetic measurements — the trial was not designed to measure whether the drug reduced any symptoms or health conditions, so no such findings are presented 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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NCT01720446 · results posted 15 March 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 3,297 people across four groups: some received a weekly injection of semaglutide at either a 0.5 mg or 1.0 mg dose, and others received a placebo (an inactive dummy injection) at the matching dose level. The trial was measuring whether there was a difference in the rate of serious heart-related events — specifically cardiovascular death, heart attack, or stroke — between people taking semaglutide and those taking placebo. Most participants completed the trial, with between 804 and 812 people finishing in each group. The reported data shows that 6.6% of participants in the semaglutide group experienced one of those major heart-related events (cardiovascular death, non-fatal heart attack, or non-fatal stroke), compared with 8.9% in the placebo group. For a broader set of heart-related events that also included hospitalisation for unstable chest pain, heart failure, or procedures to restore blood flow, the reported figures were 12.1% for the semaglutide group and 16.0% for the placebo group. When looking at death from any cause combined with non-fatal heart attack or stroke, the reported percentages were 7.4% (semaglutide) and 9.6% (placebo). The reported data also shows changes in blood sugar levels: HbA1c (a measure of average blood sugar over roughly three months) fell by an average of 1.09 percentage points in the 0.5 mg semaglutide group and 1.41 percentage points in the 1.0 mg group, compared with 0.44 and 0.36 percentage points in the respective placebo groups. Fasting blood sugar also fell more in the semaglutide groups than in the placebo 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02298803 · results posted 28 February 2018
According to the results reported on ClinicalTrials.gov, 30 people took part in this trial and all 30 completed it. Every participant wore a Holter monitor (a device that continuously records heart electrical activity) and a continuous glucose monitor at the same time, over two consecutive days and nights. The trial was looking at whether low blood sugar (called hypoglycaemia — when blood glucose drops below 3.5 mmol/L) was associated with changes in something called the QTc interval, which is a measure of the timing of the heart's electrical cycle. A longer or shorter QTc interval can sometimes be linked to irregular heart rhythms. The reported data shows that 8 of the 30 participants experienced low blood sugar during the night. Of those 8, 3 showed a lengthening of their QTc interval during the low blood sugar period, and 5 showed a shortening. During the daytime, only 3 participants experienced low blood sugar: 2 showed a lengthening and 1 showed a shortening of the QTc interval. The individual differences in QTc timing during nighttime low blood sugar ranged from minus 8 milliseconds (a shortening) to plus 15 milliseconds (a lengthening) across the 8 participants. A secondary measure looked at whether the size of blood sugar swings (called MAGE — a way of scoring how much glucose levels go up and down) was related to the QTc change; the reported correlation figure was 0.09, which indicates very little mathematical relationship between the two measures in this 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 ↗ · Linked publication on PubMed ↗
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NCT01119846 · results posted 17 January 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 100 participants across three parts (Part A, Part B, and Part C). Part A had 13 participants, Part B had 4, and Part C had 83. Of those who started, 11, 4, and 72 completed each part respectively. The trial was measuring a range of things including unwanted medical events (called adverse events), blood test results, heart trace (ECG) readings, blood pressure and pulse, and how much of the study drug (GSK1292263) was absorbed into the bloodstream. Part A compared different doses of GSK1292263 (25 mg, 150 mg, and 800 mg) against a placebo (inactive treatment) and an existing diabetes medicine called sitagliptin. The reported data shows that in Part A, the number of participants who experienced adverse events was: 2 out of those on placebo, 2 on the 25 mg dose, 2 on the 150 mg dose, 4 on the 800 mg dose, and 2 on sitagliptin. No serious adverse events were reported in any group in Part A. For abnormal blood test results flagged as potentially clinically important, very small numbers were reported — for example, 1 participant in the 150 mg group and 1 in the sitagliptin group had a notable haemoglobin reading, and 1 participant in the 25 mg group had a notable chemistry result. No participants in any group were reported to have clinically significant abnormal ECG findings or abnormal vital signs (blood pressure and pulse). Regarding how much of the drug reached the bloodstream, the reported peak concentration figures were 52.04 nanograms per millilitre for the 25 mg dose, 165.62 for the 150 mg dose, and 379.79 for the 800 mg dose. Data for the secondary outcome measures was not included in the submitted results provided here. It is worth noting that outcome data for Parts B and C does not appear in the submitted results data available here, so those figures cannot be 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02435277 · results posted 18 December 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02435277) enrolled 50 people in total, split across four groups. Three groups received different doses of a fixed-dose combination (FDC) of leucine and metformin — labelled FDC 125, FDC 250, and FDC 500 — while a fourth "control" group received standard metformin on its own. The trial ran for 12 weeks and was primarily measuring changes in HbA1c (a blood marker that reflects average blood sugar levels over roughly three months) and fasting plasma glucose (a measure of blood sugar after not eating). The reported data shows the following changes in HbA1c over 12 weeks: the FDC 125 group saw an average increase of 0.10 percentage points; the FDC 250 group saw an average decrease of 0.12 percentage points; the FDC 500 group saw an average decrease of 0.05 percentage points; and the control (standard metformin) group saw an average decrease of 0.83 percentage points. For fasting plasma glucose (measured in mg/dL, a unit for blood sugar concentration), the reported changes were: FDC 125 decreased by 15.8; FDC 250 increased by 11.2; FDC 500 decreased by 4.3; and the control group decreased by 36.3. The trial notes described what appeared to be a dose-related pattern across the combination treatment groups for the glucose measure, though the data was not reported in a way that allows further interpretation here. It is worth noting that the groups were quite small — between 11 and 16 people each — and some participants did not complete the study (two in the FDC 125 group and one in the FDC 250 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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NCT02481141 · results posted 11 December 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 53 people with type 2 diabetes living in Bahrain — 35 in the group receiving the investigational treatment (called 5-ALA-SFC) and 18 in the placebo group (a dummy treatment with no active ingredient). Of those who started, 26 in the treatment group and 13 in the placebo group completed the trial. The study was measuring two main things: how many participants experienced adverse events (unwanted health events recorded during the trial), and how fasting blood glucose levels (a measure of blood sugar after not eating) changed over time. The treatment was given at increasing doses across three phases lasting up to 12 weeks in total. The reported data shows that for adverse events, the numbers of participants who experienced them were: 6 (treatment group, weeks 0–2), 8 (treatment group, weeks 0–4), and 2 (treatment group, weeks 0–12); compared with 3, 1, and 1 in the placebo group across the same phases. For fasting blood glucose, the reported changes from the starting level were small in both groups across all phases — ranging from a slight rise of 2.3 mg/dL to a drop of 3.0 mg/dL in the treatment group, and drops of 0.8 to 7.3 mg/dL in the placebo group. For secondary measures, blood sugar taken two hours after a meal fell in both groups, with the placebo group showing larger reported drops (up to −33.0 mg/dL) than the treatment group (up to −12.9 mg/dL). A long-term blood sugar marker called HbA1c (a percentage reflecting average blood sugar over roughly three months) showed small reported decreases in both groups — up to −0.7% in the treatment group and −0.5% in the placebo group. Body weight and total cholesterol changes were also small in both groups across the reported 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02420262 · results posted 7 December 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 252 people in one group (receiving a combination insulin called IDegLira) and 254 people in another group (receiving a combination of two separate insulins, IGlar and IAsp). The vast majority of participants completed the trial — 250 in the first group and 249 in the second. 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). Several secondary things were also tracked, including episodes of low blood sugar (hypoglycaemia), changes in body weight, and how many participants reached certain HbA1c targets. The reported data shows that, after 26 weeks, the average HbA1c level fell by 1.48 percentage points in the IDegLira group and by 1.46 percentage points in the IGlar + IAsp group. For the secondary outcomes, the number of low blood sugar episodes recorded during the study was 129 in the IDegLira group and 975 in the IGlar + IAsp group. On body weight, the IDegLira group recorded an average decrease of 0.93 kg, while the IGlar + IAsp group recorded an average increase of 2.64 kg. Regarding blood sugar targets, the reported data shows 157 participants in the IDegLira group and 156 in the IGlar + IAsp group had an HbA1c below 7.0%, and 118 versus 104 participants respectively had an HbA1c below or equal to 6.5% (noting the data for this outcome contained some figures that were not entirely clear 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 ↗
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NCT02202161 · results posted 6 November 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people in total across eight groups. Six groups received different doses of an investigational medicine called GSK2330672 (taken twice daily), one group received a comparison medicine called sitagliptin, and one group received a placebo (a dummy treatment with no active ingredient). A separate small group of six people took part in a preliminary "run-in" phase only and did not continue into the main trial. The trial was measuring changes in blood sugar (glucose) levels over a 24-hour period, as well as tracking a range of safety-related observations such as unwanted medical events, blood test results, and urine test results. The reported data shows that blood sugar levels fell from the starting point in all groups over the course of the trial. In the placebo group, the reported average reduction in a key blood sugar measure (a calculation of glucose levels across the day) was around 6.6 mg/dL for fasting glucose and around 10 mg/dL for the all-day weighted average. Among the GSK2330672 groups, the reported reductions varied by dose — for example, the 30 mg twice-daily group showed the largest reported average fall of around 38.6 mg/dL (fasting) and 48.7 mg/dL (all-day average), while the 20 mg twice-daily group showed the smallest reported reductions at around 1.4 mg/dL and 16.2 mg/dL respectively. The sitagliptin group showed a reported average reduction of around 24.5 mg/dL. Note that not all dose-group figures for the all-day average were included in the submitted data. The reported data shows that, for safety-related measures, unwanted medical events (adverse events) were recorded in 9 out of 13 placebo participants, and in between 4 and 8 participants across the various GSK2330672 dose groups, and in 8 of 13 sitagliptin participants. One serious adverse event was reported in the 10 mg GSK2330672 group; none were reported in the placebo group or most other groups, though data for some groups was not fully reported. Abnormal blood chemistry results of potential clinical concern were noted in small numbers of participants across several groups (ranging from 0 to 2 per group), and abnormal urine findings were recorded in isolated participants in a few groups. One participant in the 90 mg GSK2330672 group had an abnormal blood count result of potential clinical concern; no others did. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01503164 · results posted 19 October 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 111 participants in total — 55 in a group receiving Positive Pressure Therapy (PAP, a breathing treatment commonly used for sleep apnoea) and 56 in a group receiving Lifestyle Counselling. Nearly all participants completed the study (53 in the PAP group and 55 in the Lifestyle Counselling group). The trial was measuring how the body responds to insulin — a hormone that helps control blood sugar — along with two related measures of how the body handles glucose (sugar). These measurements were taken before and after two months of each intervention. The reported data shows the following numbers for the main measure, called Insulin Sensitivity (SI), where a higher number means the body is responding better to insulin. Before the interventions began, the PAP group recorded an average SI of 1.95 and the Lifestyle Counselling group recorded 2.22. After two months, the PAP group's average SI was reported as 3.01, while the Lifestyle Counselling group's average SI was reported as 1.83. For the secondary measures, glucose effectiveness (how well the body moves sugar into cells without insulin's help) was reported as 0.01498 (PAP) and 0.01537 (Lifestyle Counselling) at the start, and 0.01720 (PAP) and 0.01385 (Lifestyle Counselling) at the end. The Disposition Index — a combined score where a lower number is associated with a higher risk of developing diabetes — was reported as 931.4 (PAP) and 1093.1 (Lifestyle Counselling) at the start, and 1385.9 (PAP) and 815.4 (Lifestyle Counselling) after two months. No further detail about the statistical meaning of these differences 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 ↗
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NCT01095666 · results posted 11 September 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 444 adults across three groups: 145 received a placebo plus metformin, 147 received a 5 mg dose of dapagliflozin plus metformin, and 152 received a 10 mg dose of dapagliflozin plus metformin. 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 the previous three months. Secondary measurements included fasting blood sugar levels, blood sugar levels two hours after a meal, body weight, and how many participants reached an HbA1c below 7.0%. The reported data shows that for the main measure — change in HbA1c after 24 weeks — the placebo plus metformin group saw an average reduction of 0.23 percentage points, while the 5 mg dapagliflozin group saw a reduction of 0.82 percentage points, and the 10 mg dapagliflozin group saw a reduction of 0.85 percentage points. For fasting blood sugar, the placebo group recorded an average rise of 0.5 mg/dL, compared with average reductions of 21.6 mg/dL and 26.6 mg/dL in the 5 mg and 10 mg dapagliflozin groups respectively. For blood sugar measured two hours after a meal, the reported average changes were a reduction of 15.5 mg/dL in the placebo group, 57.8 mg/dL in the 5 mg group, and 64.6 mg/dL in the 10 mg group. The reported data also shows that average body weight changed by minus 0.74 kg in the placebo group, minus 1.84 kg in the 5 mg dapagliflozin group, and minus 2.56 kg in the 10 mg dapagliflozin group over 24 weeks. Regarding the proportion of participants who reached an HbA1c below 7.0%, the reported figures were approximately 17.5% in the placebo group, 32.9% in the 5 mg group, and 33.0% in the 10 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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NCT02131272 · results posted 1 September 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 42 young people with type 2 diabetes — 20 in a group using insulin detemir combined with metformin and lifestyle changes (diet and exercise), and 22 in a group using a different insulin called NPH combined with metformin and the same lifestyle changes. The trial ran for 26 weeks and was primarily measuring changes in a blood marker called HbA1c — a measure of average blood sugar levels over roughly three months — as well as several other outcomes including body weight and episodes of very low blood sugar (hypoglycaemia). The reported data shows that, on average, HbA1c levels fell in both groups over the 26 weeks. The insulin detemir group had an estimated average decrease of 0.64 percentage points, while the insulin NPH group had an estimated average decrease of 0.81 percentage points. For body weight, both groups showed very small changes in a standardised weight score (a way of comparing weight against typical values for age and sex): the insulin detemir group recorded a change of 0.006 and the insulin NPH group 0.098 — both very close to zero. Regarding blood sugar targets, the reported data shows that 25% of participants in the insulin detemir group and 33.3% in the NPH group reached an HbA1c below 7.0% without experiencing a severe hypoglycaemic episode in the final 14 weeks; at the slightly higher target of below 7.5%, those figures were 30.0% and 38.1% respectively. For low blood sugar episodes requiring another person's help or confirmed by a blood test, the insulin detemir group had 4 such episodes recorded overall and zero overnight, while the insulin NPH group had 12 such episodes overall and 1 overnight. 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 ↗
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NCT01929863 · results posted 16 August 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01929863) involved 15 participants in total — 7 in one group and 8 in the other. It used a "crossover" design, meaning each participant tried both combinations at different times: one group received the investigational medicine GSK2330672 together with metformin first, then switched to a placebo (a dummy pill) together with metformin; the other group did it in the reverse order. There was a washout period of roughly two weeks in between to clear the previous treatment from participants' systems. The trial was primarily measuring safety-related outcomes — specifically, how many participants experienced unwanted medical events, serious medical events, or death, as well as changes in blood and urine test results. The reported data shows that when it came to general unwanted medical events (called adverse events), 12 out of 13 participants who received GSK2330672 plus metformin experienced at least one, compared with 9 out of 13 participants who received the placebo plus metformin. One participant in the GSK2330672 plus metformin group was reported to have experienced a serious adverse event; none were reported in the placebo plus metformin group. No deaths were reported in either group. For blood sugar levels flagged as unusually high in routine blood chemistry checks, 0 participants in either active or placebo treatment periods were flagged, but 2 participants were flagged during the follow-up period. One participant in the GSK2330672 plus metformin group had a white blood cell count flagged as outside the normal range; none were flagged in the other groups. Various urine test results also showed small numbers of participants with readings outside normal ranges across both treatment groups and the follow-up period, with the reported data showing this was not confined to one group. Urine concentration (specific gravity) readings were reported as similar across both treatment groups and the follow-up 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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NCT01424306 · results posted 14 August 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01424306) enrolled 25 people in total, divided into six groups that each received three different sweeteners — fructose, glucose, and high-fructose corn syrup (HFCS) — in a different order. Twenty-four participants completed the study (one person in one of the groups did not finish). The trial was looking at how each sweetener affected certain markers in the blood and gut after an 8-day diet period. The main things being measured were two substances linked to inflammation in the body: C-reactive protein (CRP) and interleukin-6 (IL-6). Several other markers were also tracked, including a hormone called adiponectin, daily calorie intake, and two measures of how "leaky" the gut lining was (intestinal permeability). The reported data shows that for CRP — measured at the start and end of each 8-day diet — levels were 0.91 mg/L at the start and 1.07 mg/L at the end of the fructose period; 1.67 mg/L at the start and 1.09 mg/L at the end of the glucose period; and 1.18 mg/L at the start and 0.84 mg/L at the end of the HFCS period. For IL-6, measured at the end of each diet period, the reported figures were 0.97 pg/mL (fructose), 1.14 pg/mL (glucose), and 0.96 pg/mL (HFCS). For the secondary measures at the end of each diet period: adiponectin levels were 4,635 ng/mL (fructose), 4,353 ng/mL (glucose), and 4,514 ng/mL (HFCS). Average daily calorie intake was similar across all three diets — approximately 2,970, 2,940, and 2,950 calories per day respectively. The gut permeability ratio (a measure of how much of two test sugars passed into the urine) was 0.047 for fructose, 0.043 for glucose, and 0.031 for HFCS. Zonulin, another marker of gut leakiness, was 12.78 ng/mL (fructose), 12.69 ng/mL (glucose), and 12.92 ng/mL (HFCS). 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 ↗
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NCT01514149 · results posted 19 July 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01514149) involved 73 people in total across five groups. Four groups received different doses or schedules of a weekly injection called CJC-1134-PC (with group sizes of 15, 15, 14, and 14 participants), while a fifth group of 15 people received a weekly placebo (a dummy injection with no active ingredient). The trial ran for 18 weeks and was primarily measuring changes in a blood marker called glycosylated haemoglobin — a way of tracking average blood sugar levels over roughly three months. It also looked at changes in body weight and how long it took before some participants needed extra treatment to bring their blood sugar under control. The reported data shows that, for the main measure (blood sugar marker), all four CJC-1134-PC groups and the placebo group saw a reduction from their starting level by week 18. The reductions in the CJC-1134-PC groups ranged from −0.56% to −0.95%, while the placebo group showed a reduction of −0.13%. For body weight, the reported changes ranged from a loss of around 0.14 kg to 1.91 kg across the CJC-1134-PC groups, compared with a loss of 1.85 kg in the placebo group. Regarding the time until some participants needed extra blood sugar treatment, this figure was only reported for one of the CJC-1134-PC groups (47 days) and the placebo group (57 days); the data was not reported for the remaining 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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NCT02320721 · results posted 11 July 2017
According to the results reported on ClinicalTrials.gov, this trial compared two long-acting insulin products — HOE901-U300 (also known as insulin glargine 300 units/mL) and Lantus (insulin glargine 100 units/mL) — in people with diabetes. A total of 1,014 participants were enrolled (508 in the HOE901-U300 group and 506 in the Lantus group), and the trial ran for 26 weeks. The main thing being measured was the change in a blood sugar marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly three months — from the start of the trial to week 26. The reported data shows that, on average, HbA1c fell by 0.89 percentage points in the HOE901-U300 group and by 0.91 percentage points in the Lantus group over the 26 weeks. For the secondary outcomes, the trial also tracked how many participants experienced episodes of low blood sugar (hypoglycaemia — when blood sugar drops to a potentially harmful level). During the full 26-week period, roughly 48.3% of the HOE901-U300 group and 47.7% of the Lantus group were reported to have had at least one low blood sugar episode overnight (between 10 pm and 9 am). In the narrower overnight window of midnight to 6 am, the reported figures were 20.2% and 22.5% respectively. For low blood sugar episodes at any time of day, the reported figures were 59.4% (HOE901-U300) and 62.7% (Lantus). The trial also measured how many participants reached an HbA1c below 7.5% or below 7.0%, and how many reached those targets without also having a low blood sugar episode — the numbers for each of those measures are 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02371759 · results posted 3 May 2017
According to the results reported on ClinicalTrials.gov, this trial looked at local anaesthetic injections used to numb the mouth during dental procedures. It compared two different anaesthetic mixtures — one combined with clonidine (L+C) and one combined with epinephrine (L+E) — given in either the upper jaw or the lower jaw, in two groups of people: those with diabetes and those without. A total of 233 people started the trial across eight groups, and 220 completed it. The trial measured how long the numbness lasted, how much sensation participants still felt during pin-prick testing, and how their blood pressure changed at several time points after the injection. The reported data shows that, for how long the numbness lasted, the figures ranged from around 109 minutes to around 195 minutes depending on the group. The longest average duration (about 195 minutes) was recorded in the diabetic group who received the L+E mixture in the lower jaw, while the shortest (about 109 minutes) was in the healthy group who received the L+C mixture in the upper jaw. For the pin-prick sensation test — which counted how many participants still felt something when they should have been fully numb — the numbers were small across most groups, ranging from 1 to 8 participants per group reporting some sensation. Regarding blood pressure, the reported starting (baseline) systolic blood pressure (the top number in a blood pressure reading) was generally higher in the diabetic groups (around 134–138 mm Hg) than in the healthy groups (around 124–128 mm Hg). The reported blood pressure readings at 10, 15, and 20 minutes after the injection showed modest variation across all groups, with figures generally staying in a similar range to baseline; no dramatic changes were reported in the data 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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NCT03047447 · results posted 25 April 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT03047447) enrolled 30 adults in total, split evenly into three groups of 10: one group followed a ketogenic diet, one followed a standard American diet with regular exercise (3–5 days per week), and one followed a standard American diet without exercise. All 30 participants completed the study. The trial ran for 10 weeks and tracked several measurements including HbA1c (a blood marker that reflects average blood sugar levels over roughly 2–3 months), body weight, body mass index (BMI, a ratio of weight to height), body fat mass, and blood ketone levels (ketones are molecules the body produces when burning fat for fuel). The reported data shows the following changes from the start of the trial to week 10. For HbA1c, the ketogenic group's average reading changed by −0.42 percentage points, the exercise group by −0.37 percentage points, and the no-exercise group by +0.02 percentage points. For body weight, the ketogenic group's average changed by −28.40 pounds, the exercise group by −2.87 pounds, and the no-exercise group by −2.43 pounds. For BMI, the changes were −4.4, −0.01, and −0.42 kg/m² respectively. For body fat mass, the reported changes were very small: −0.03, −0.01, and 0.00 pounds across the three groups. For blood ketone levels, the changes from baseline were +0.24 mmol/L in the ketogenic group, +0.07 in the exercise group, and +0.04 in the no-exercise group. It is worth noting that these figures represent averages across only 10 people per group, which is a very small number. No further breakdown or additional detail beyond these average change figures was 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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NCT00886821 · results posted 18 April 2017
According to the results reported on ClinicalTrials.gov, this trial tested a drug called PF-04856883, given by injection under the skin, across two stages. In Stage 1, the trial enrolled 56 participants who received one of nine different dose levels of the drug (ranging from 0.1 mg to 36 mg), plus 18 participants who received a placebo (an inactive injection). In Stage 2, a further 31 participants received one of three additional dose levels (15 mg, 20 mg, or 25 mg), alongside 9 placebo participants. All participants in Stage 1 completed that stage; in Stage 2, a small number did not complete (1 in the 20 mg group, 5 in the 25 mg group, and 1 in the placebo group). The trial was primarily measuring how the drug behaved in the body — specifically how much of it reached the bloodstream and how quickly. The reported data shows several measurements tracking the drug's behaviour at different doses. One key measure was the peak level of the drug detected in the blood (called Cmax). According to the results reported on ClinicalTrials.gov, this ranged from a low of 7.05 nanograms per millilitre (ng/mL) at the smallest dose (0.1 mg) up to 1,554 ng/mL at the 20 mg dose used in Stage 2. The time it took for the drug to reach that peak level (called Tmax) was also tracked; across the different dose groups on the first day of dosing, this ranged from about 72 hours to 168 hours (roughly 3 to 7 days). Another measure tracked the overall amount of drug in the bloodstream over time (called AUClast, which reflects the total drug exposure); the reported data shows this ranged from 865 to 304,167 nanogram-hours per millilitre across the single-dose Stage 1 groups. No placebo group numbers were reported for these drug-level measurements, as placebo recipients would not have the drug in their 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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NCT01964950 · results posted 13 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,101 people with type 2 diabetes in Japan who were taking a medicine called alogliptin, either alongside a class of diabetes tablets known as sulfonylureas (SU) or alongside other diabetes medicines. Of those who started, 1,076 completed the study. The trial was measuring two main things: how many participants experienced unwanted reactions that doctors linked to the study medicine (called adverse drug reactions), and how blood sugar levels changed over up to 12 months. The reported data shows that, among the 1,101 participants, those taking alogliptin with a sulfonylurea had 19 people report one or more adverse drug reactions linked to the treatment, while only 1 person in the "other medicines" group did. For serious reactions — ones involving hospitalisation, life-threatening events, disability, or death — the reported data shows 5 people in the sulfonylurea group and none in the other group experienced an event considered by their doctor to be linked to the treatment. Regarding blood sugar, participants started with an average HbA1c (a measure of blood sugar control over roughly three months) of about 8.03%. The reported data shows this figure fell by around 0.40 percentage points at one month, and by roughly 0.64–0.72 percentage points at later time points. Fasting blood glucose (sugar measured after not eating) started at around 151 mg/dL on average and was reported to be around 13–16 mg/dL lower at each follow-up point. Fasting insulin levels showed small increases across the follow-up period. The reported data also shows changes in the proportion of participants reaching certain blood sugar targets: at the start, 56.3% had HbA1c below 8.0% and 19.3% were below 7.0%; by the final visit, those figures had risen to 75.4% and 43.0% 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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NCT01635062 · results posted 11 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people in total — 9 who received calcitriol (a form of vitamin D) and 9 who received a placebo (a dummy treatment). All 18 participants completed the study. The trial was measuring how calcitriol affected the body's blood-pressure-regulating system (known as the renin-angiotensin system, or RAS), as well as blood flow through the kidneys and protein levels in the urine. Participants went through controlled periods of both low-salt and high-salt diets before and after receiving their assigned treatment for three weeks. The reported data shows the following changes from the start of the study to after treatment. For the main measure — a marker of the RAS called plasma renin activity (a substance in the blood that helps regulate blood pressure, measured in ng/mL/h) — the calcitriol group showed a change of 0, while the placebo group showed a change of −1.3. For kidney blood flow (measured in mL/min/1.73m²), the calcitriol group showed a change of −16.4, compared with −0.6 in the placebo group. For protein in the urine (measured in mg over 24 hours), the calcitriol group showed a change of +21.1, while the placebo group showed a change of +8.1. The data as submitted does not include information such as starting values or measures of variability around these figures. 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 ↗
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NCT00858013 · results posted 31 March 2017
According to the results reported on ClinicalTrials.gov, this trial compared two diabetes medications — nateglinide and glimepiride — in people with type 2 diabetes. A total of 46 people were assigned to the nateglinide group and 42 to the glimepiride group. The trial ran for 24 months and was mainly looking at how many participants in each group had to stop their assigned medication because their blood sugar control (measured by a test called HbA1c, which reflects average blood sugar levels over roughly three months) rose too high — above 8.0%. By the end of the study, 24 people in the nateglinide group and 23 in the glimepiride group had completed the full trial period. The reported data shows that 10 participants in the nateglinide group and 7 in the glimepiride group withdrew from the study because their HbA1c exceeded that 8.0% threshold. For the secondary measures recorded at 24 months, the nateglinide group had a reported average HbA1c of 6.9% compared with 6.5% in the glimepiride group. Average fasting blood sugar levels were reported as 131.2 mg/dL (nateglinide) versus 115.7 mg/dL (glimepiride). A marker related to insulin production called C-peptide was reported as 1.29 uU/mL in the nateglinide group and 1.77 uU/mL in the glimepiride group. A measure of insulin resistance called HOMA-IR — a calculation that reflects how hard the body is working to manage blood sugar — was reported as 2.40 for nateglinide and 2.31 for glimepiride. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01792518 · results posted 6 March 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01792518) enrolled 360 adults — 178 in the placebo group and 182 in the linagliptin 5 mg group. Most participants completed the 24-week study (170 and 175 respectively). 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 two kidney-related measures: the ratio of a protein called albumin to creatinine in urine (UACR, a marker sometimes used to assess kidney stress), and the estimated rate at which the kidneys filter blood (eGFR). The reported data shows that after 24 weeks, average HbA1c levels changed by −0.03 percentage points in the placebo group and −0.63 percentage points in the linagliptin group — meaning both groups showed a small reduction, with the linagliptin group showing a larger average reduction. For the urine albumin-to-creatinine ratio (UACR), the reported figures were expressed as adjusted averages relative to starting levels: 0.95 for the placebo group and 0.89 for the linagliptin group (a value below 1.0 indicates the average was lower than the starting point). For the kidney filtration rate (eGFR), both groups showed an average decline from their starting values after 24 weeks — a change of −2.35 units in the placebo group and −4.98 units in the linagliptin group. The reported data shows numbers for all three measures across both groups, but this summary does not draw any conclusions about what those differences mean clinically. 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 ↗
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NCT01179048 · results posted 1 March 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01179048) enrolled 9,340 people in total — 4,668 in the liraglutide group and 4,672 in the placebo group. The trial was measuring heart and blood vessel-related events in people who received either liraglutide (a medicine used in type 2 diabetes) or a dummy treatment (placebo). The main thing researchers tracked was how many participants experienced a first serious cardiovascular event — specifically, a heart-related death, a non-fatal heart attack, or a non-fatal stroke — over the course of the study. A range of other outcomes, including deaths from any cause and complications affecting small blood vessels (such as in the kidneys and eyes), were also tracked. The reported data shows that for the main outcome, 13.0% of people in the liraglutide group and 14.9% of people in the placebo group experienced one of those three serious cardiovascular events. For a broader combined measure that also included hospitalisation for heart failure or unstable chest pain, and procedures to restore blood flow to the heart, the reported figures were 20.3% (liraglutide) and 22.7% (placebo). Deaths from any cause were reported in 8.2% of the liraglutide group and 9.6% of the placebo group. For small blood vessel complications — covering kidney and eye-related events — 7.6% of the liraglutide group and 8.9% of the placebo group experienced at least one such event. The reported data also shows figures for the individual components of these combined measures; for example, cardiovascular death occurred in 4.7% (liraglutide) versus 6.0% (placebo), non-fatal heart attack in 3.4% versus 3.8%, and non-fatal stroke in 6.0% versus 6.8%. 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 ↗
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NCT02058160 · results posted 10 February 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02058160) enrolled 736 people in total — 367 in the combination treatment group (insulin glargine combined with lixisenatide, given as a single fixed-ratio injection) and 369 in the insulin glargine-alone group. The main thing the trial was measuring was the change in a blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over roughly three months) after 30 weeks of treatment. A number of secondary things were also measured, including blood sugar levels after meals, body weight, and how many participants reached certain HbA1c targets. The reported data shows that, for the primary measure, the combination group's average HbA1c fell by 1.13 percentage points from their starting level, while the insulin glargine-alone group's average fell by 0.62 percentage points. For the secondary measures, the reported data shows that 54.9% of participants in the combination group and 29.6% in the insulin glargine-alone group had an HbA1c below 7.0% at week 30; for the stricter cut-off of 6.5% or below, the figures were 33.9% and 14.2% respectively. Blood sugar levels measured two hours after a meal fell on average by 3.9 mmol/L in the combination group and by 0.47 mmol/L in the insulin glargine-alone group. Average body weight changed by −0.67 kg (a small decrease) in the combination group and +0.7 kg (a small increase) in the insulin glargine-alone group. The average blood sugar across seven daily measurement points fell by 1.5 mmol/L in the combination group and 0.6 mmol/L in the insulin glargine-alone group. Finally, 34.2% of the combination group and 13.4% of the insulin glargine-alone group were reported to have reached an HbA1c below 7.0% without gaining body weight. 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 ↗
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NCT02318693 · results posted 23 January 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 53 people in total — 26 taking a medicine called sitagliptin (50 mg) and 27 taking a medicine called glibenclamide (2.5 mg). One person in the glibenclamide group did not complete the study, so 26 participants in each group finished. The trial was measuring how much blood sugar levels fluctuated over the course of the day in people with type 2 diabetes, comparing the two medicines over approximately 13 days. Blood sugar was tracked continuously using a small monitoring device worn by participants, and readings were also checked manually via finger-prick tests. The reported data shows that the main thing being measured was a score called MAGE — essentially a way of capturing how widely blood sugar levels were swinging up and down throughout the day (a lower score means smaller swings). From the start of the trial to day 13, the sitagliptin group's MAGE score fell by 18.5 mg/dL on average, while the glibenclamide group's fell by 9.7 mg/dL. For secondary measurements, the reported data shows the spread (variability) of blood sugar readings over 24 hours dropped by 10.2 mg/dL in the sitagliptin group and 4.2 mg/dL in the glibenclamide group. When looking at average blood sugar across the whole day, the sitagliptin group's fell by 19.1 mg/dL and the glibenclamide group's fell by 34.8 mg/dL. The reported data also shows changes in blood sugar spikes after meals (breakfast, lunch, and dinner) and in the percentage of time blood sugar readings fell below certain low thresholds (below 70, 60, and 50 mg/dL — what researchers call hypoglycaemia, or very low blood sugar). For low blood sugar readings below 70 mg/dL, the sitagliptin group showed a 0.3% decrease in such readings, while the glibenclamide group showed a 0.8% increase. Results for the other thresholds and individual meals were also 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02100475 · results posted 20 January 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02100475) enrolled 31 people with diabetes across two groups: 16 people received a combination insulin called IDegLira on its own, and 15 received IDegLira together with an additional insulin called IAsp (a fast-acting mealtime 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. It also tracked changes in body weight and the number of episodes of low blood sugar (hypoglycaemia — when blood sugar drops to a potentially harmful level). The reported data shows that, after 26 weeks, the HbA1c figure in the IDegLira-only group fell by an average of 0.43 percentage points from where it started, while in the IDegLira + IAsp group it fell by an average of 0.14 percentage points. For body weight, the reported data shows an average increase of 0.9 kg in the IDegLira-only group and 1.5 kg in the IDegLira + IAsp group over the same period. Regarding low blood sugar episodes, the IDegLira-only group recorded a total of 34 confirmed episodes across participants during the trial, compared with 4 episodes in the IDegLira + IAsp group. It is worth noting that this was a small trial — around 14–15 people per group actually completed it — so the numbers reflect a very limited group of 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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NCT01952145 · results posted 20 January 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 278 people in the IDegLira group (a combination of two diabetes medicines, insulin degludec and liraglutide, given together) and 279 people in the insulin glargine group (a separate, single diabetes medicine). The trial ran for 26 weeks and was mainly measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly the past three months — comparing the two treatment groups. The reported data shows that, after 26 weeks, the IDegLira group had an average reduction in HbA1c of 1.81 percentage points from where they started, while the insulin glargine group had an average reduction of 1.13 percentage points. For body weight, the IDegLira group had an average decrease of 1.4 kg from their starting weight, while the insulin glargine group had an average increase of 1.8 kg. The trial also counted episodes of confirmed hypoglycaemia — that is, when blood sugar dropped to a low level (below 3.1 mmol/L) or the person needed help from someone else to recover. The reported data shows 289 such episodes in the IDegLira group and 683 episodes in the insulin glargine group over the course of the trial. It is worth noting that 28 participants did not complete the trial in the IDegLira group, compared with 14 in the insulin glargine group, though the reasons for this were not detailed 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00868790 · results posted 11 January 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT00868790) tested an investigational drug called MK-3577 in people with type 2 diabetes. A total of 118 participants were enrolled across 14 different groups, with each group receiving the treatments in a different order — including MK-3577 taken in the morning (AM), in the evening (PM), or twice daily (BID), a placebo (a dummy treatment with no active ingredient), and in some groups, metformin (an existing diabetes medicine) for comparison. The trial ran across four treatment periods and measured things like blood sugar levels and cholesterol. The reported data shows that for the main measure — the change in average 24-hour blood glucose levels after four weeks — participants taking placebo saw a change of −1.6 mg/dL (milligrams per decilitre, a unit for measuring blood sugar). Those taking MK-3577 in the morning saw a change of −18.8 mg/dL, those taking it in the evening saw −25.0 mg/dL, and those taking it twice daily saw −36.5 mg/dL. A result for the metformin group was not reported for this particular measure. For fasting blood sugar (measured after at least 12 hours without food), the reported changes were: placebo +4.3, MK-3577 AM −7.2, MK-3577 PM −17.5, MK-3577 twice daily −31.7, and metformin −14.4 mg/dL. For blood sugar measured two hours after a meal, the reported changes were: placebo −5.2, MK-3577 AM −20.1, MK-3577 PM −25.6, MK-3577 twice daily −73.0, and metformin −54.6 mg/dL. For LDL cholesterol (sometimes called "bad" cholesterol), percentage changes from the starting point were: placebo +2.3%, MK-3577 AM +1.5%, MK-3577 PM +6.8%, MK-3577 twice daily +10.0%, and metformin −1.7%. The reported data also includes a count of participants who experienced at least one adverse event (an unwanted change in health noted during the study): 28 in the placebo group, 30 in the MK-3577 AM group, and 22 in the MK-3577 PM group; figures for the remaining groups were not available 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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NCT01890122 · results posted 28 November 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 647 adults across four groups to compare different tablet treatments for type 2 diabetes over 26 weeks. The groups were: metformin alone (162 people), alogliptin alone (163 people), a combined tablet of alogliptin and metformin (159 people), and a placebo (inactive tablet, 163 people). The trial's main thing being measured was a blood marker called HbA1c — a percentage that reflects average blood sugar levels over roughly three months. A lower number means lower average blood sugar, and a negative change from the starting point means the reading went down during the trial. The reported data shows that after 26 weeks, average HbA1c readings changed from each group's starting point as follows: the metformin-alone group went down by 0.32 percentage points; the alogliptin-alone group went down by 1.23 percentage points; the combined alogliptin-and-metformin tablet group went down by 1.06 percentage points; and the placebo group went down by 1.72 percentage points. The reported data also shows changes in fasting blood sugar (a blood sugar reading taken after not eating overnight), measured in mg/dL — a unit for the amount of sugar in the blood. At the end of the study, fasting blood sugar went down by roughly 1.48 mg/dL in the metformin group, 1.33 mg/dL in the alogliptin group, 2.14 mg/dL in the combination group, and 0.08 mg/dL in the placebo group. For additional measures, the reported data shows that the percentage of participants who needed a "rescue" intervention due to very high blood sugar readings during the trial was 8.7% in the metformin group, 14.8% in the alogliptin group, 4.4% in the combination group, and 25.5% in the placebo group. The percentage of participants who recorded a notably high blood sugar reading (fasting blood sugar of 200 mg/dL or above) at any point was 8.8%, 12.7%, 5.7%, and 15.9% respectively. The data for the time-to-rescue measure was not reported for any 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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NCT01359904 · results posted 28 November 2016
According to the results reported on ClinicalTrials.gov, this trial involved 34 people in total who were receiving haemodialysis (kidney dialysis) and had type 2 diabetes. Participants were split into two groups: 15 people received a dialysis fluid containing a higher level of glucose (sugar), and 19 received the standard glucose level in their dialysis fluid. The trial was mainly measuring a blood marker called HbA1c — a percentage that reflects average blood sugar levels over roughly three months — after the study period ended. It also tracked low blood sugar episodes during dialysis, changes in HbA1c from the start to the end of the study, and infections related to the dialysis access point (the tube or vessel used to connect to the dialysis machine). The reported data shows that when the study ended, both groups had the same average HbA1c reading of 7.1%. Looking at how much each group's HbA1c changed from the beginning to the end of the study, the high-glucose dialysis fluid group showed an average rise of 0.3 percentage points, while the standard group showed an average fall of 0.1 percentage points. For episodes of low blood sugar (blood sugar dropping below 4 mmol/L) during dialysis sessions, the reported data shows 2 episodes in the high-glucose group and 10 episodes in the standard group. Regarding infections at the dialysis access site, 4 episodes were recorded in the high-glucose group and 3 in the standard 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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NCT01147250 · results posted 14 October 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01147250) enrolled 3,034 people in each group — one group received a medicine called lixisenatide and the other received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether there was a difference between the two groups in the time it took for people to experience serious heart-related events, such as death from a cardiovascular (heart or blood vessel) cause, a heart attack, a stroke, or hospitalisation for unstable chest pain (angina). Additional measurements looked at a broader range of heart-related events, and also at a kidney marker called the urinary albumin-to-creatinine ratio, which is a way of checking for signs of kidney stress. The reported data shows that for the main measurement — the number of people who experienced at least one of those serious heart-related events — 399 participants in the placebo group and 406 in the lixisenatide group had such an event. For the first broader secondary measure, which also included hospitalisation for heart failure, 469 placebo participants and 456 lixisenatide participants had an event. When the measure was expanded further to also include coronary procedures (such as stenting or bypass surgery), the reported data shows 659 events in the placebo group and 661 in the lixisenatide group. Regarding the kidney marker at around two years (week 108), the placebo group showed a reported change of approximately +34% from their starting level, while the lixisenatide group showed a reported change of approximately +24%; the data does not include further detail explaining what drove this difference. 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 ↗
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NCT01798706 · results posted 14 October 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01798706) enrolled 350 people with type 2 diabetes — 176 in the lixisenatide group and 174 in the placebo group. Around 155 and 153 people respectively completed the study. The trial ran for 24 weeks and was primarily measuring changes in HbA1c, which is a blood test that reflects average blood sugar levels over roughly three months. A number of secondary measurements were also tracked, including blood sugar levels after a meal, fasting blood sugar, body weight, and how many participants needed extra (rescue) medication during the study. The reported data shows that, on average, HbA1c fell by 0.57 percentage points in the lixisenatide group, compared with a rise of 0.06 percentage points in the placebo group. For blood sugar measured two hours after eating, the lixisenatide group showed an average reduction of 5.12 mmol/L, while the placebo group showed almost no change (−0.07 mmol/L). A broader daily blood sugar measure (average of seven readings across the day) fell by 1.15 mmol/L in the lixisenatide group versus 0.19 mmol/L in the placebo group. Fasting blood sugar dropped by 0.3 mmol/L with lixisenatide and was essentially unchanged with placebo. Body weight fell on average by 1.47 kg in the lixisenatide group and 0.16 kg in the placebo group. The reported data also shows that approximately 2.9% of participants in the lixisenatide group needed rescue medication during the 24 weeks, compared with 10.4% in the placebo group. These numbers reflect what was recorded and reported in this specific trial under its particular conditions, and do not necessarily represent what any individual person might experience. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00739336 · results posted 5 October 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT00739336) involved 45 people in total — 21 in the intervention group and 24 in the control group. The trial was measuring changes in body weight, fasting blood sugar levels, a type of cholesterol called LDL, and a blood sugar marker called HbA1c (which reflects average blood sugar levels over a few months). Of the 21 people in the intervention group, 17 completed the study, while all 24 people in the control group completed it. Two additional secondary measures — waist circumference and questionnaire results — were listed but no data was reported for them. The reported data shows that, on average, people in the intervention group had a change in body weight of −2.3 kg (that is, a reduction), while those in the control group had a change of +0.73 kg (a small increase). For fasting blood sugar, the intervention group recorded an average of 107 mg/dL compared to 111 mg/dL in the control group. The reported LDL cholesterol figures were 126 mg/dL for the intervention group and 112 mg/dL for the control group. The HbA1c readings were 6.2% for the intervention group and 6.4% for the control group. These figures represent the average values measured at the end of the study period for 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02025907 · results posted 2 September 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 108 people in a placebo group and 108 people in a canagliflozin group — 216 participants in total. The trial ran for 26 weeks and was primarily looking at changes in a blood marker called HbA1c, which reflects average blood sugar levels over roughly two to three months. Secondary measurements included fasting blood sugar (a blood sugar reading taken after not eating overnight), body weight, the proportion of participants whose HbA1c fell below a certain level (7.0%), and systolic blood pressure (the top number in a blood pressure reading). By the end of the study, 81 of the 108 placebo participants and 96 of the 108 canagliflozin participants had completed the trial. The reported data shows that, on average, HbA1c changed by −0.01 percentage points in the placebo group and −0.91 percentage points in the canagliflozin group over 26 weeks. For fasting blood sugar, the reported average change was −0.14 millimoles per litre in the placebo group and −1.65 millimoles per litre in the canagliflozin group. Body weight, on average, changed by −1.60% in the placebo group and −3.35% in the canagliflozin group. The reported data also shows that 12.2% of placebo participants and 32.3% of canagliflozin participants had an HbA1c below 7.0% at week 26. Regarding systolic blood pressure, the average change reported was +0.09 mmHg in the placebo group and −5.76 mmHg in the canagliflozin 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 ↗ · Linked publication on PubMed ↗
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NCT02563834 · results posted 31 August 2016
According to the results reported on ClinicalTrials.gov, this trial involved 18 people across two groups: 10 "lean" (healthy weight) participants and 8 people living with type 2 diabetes. Each person took part in two sessions on separate days — one where they received a saline (salt water) drip as a control, and another where they received an insulin drip (a so-called "insulin clamp," which is a research method used to keep blood sugar at a steady level). The trial used a type of medical imaging called PET scanning to measure three things in the heart: how quickly the heart was taking up fatty acids (fats used as fuel), how quickly the heart was burning fuel overall (oxidation), and how much blood was flowing through the heart muscle. The reported data shows the following numbers for the heart's fatty acid uptake rate, measured in units of umol/min/100g of heart tissue. During the saline session, the lean group recorded 18.5 and the type 2 diabetes group recorded 36.0. During the insulin session, those figures were 2.1 for the lean group and 7.8 for the type 2 diabetes group. For overall fuel burning (oxidation, in ml/min/100g), the reported figures were 15.0 (lean/saline), 19.8 (lean/insulin), 17.4 (type 2 diabetes/saline), and 22.9 (type 2 diabetes/insulin). For heart blood flow (also in ml/min/100g), the reported data shows 39.3 (lean/saline), 46.5 (lean/insulin), 44.2 (type 2 diabetes/saline), and 49.4 (type 2 diabetes/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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02678676 · results posted 7 July 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT02678676) involved 3,599 people with type 2 diabetes who were followed over a 10-year observational period. Participants were split into two groups: 1,820 people who had previously taken pioglitazone (a diabetes medication) and 1,779 who had previously taken a placebo (an inactive tablet). The trial was measuring how often people in each group experienced a major blood vessel-related event — such as a heart attack, stroke, leg amputation, or heart/leg surgery — or died from any cause. It also tracked how many people in each group developed any form of cancer. The reported data shows that, over the 10-year follow-up period, 58% of participants in the pioglitazone group experienced one of those major cardiovascular events or died, compared with 60.3% in the placebo group. Regarding cancer, the reported data shows that 12.9% of people in the pioglitazone group had at least one cancer diagnosis recorded, compared with 13.2% in the placebo group. It is worth noting that roughly half the participants in each group did not complete the full study period — 888 in the pioglitazone group and 872 in the placebo group did not finish — which the reported data does not fully explain. 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 ↗
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NCT01868542 · results posted 29 June 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 46 people in total, split into two groups of 23. Both groups used a long-acting insulin called insulin detemir, but each group followed a different dose-adjustment method — one called the "3-0-3 algorithm" and the other the "2-4-6-8 algorithm." These algorithms are simply different sets of rules for deciding how to adjust the insulin dose over time. The trial ran for 20 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. By the end of the trial, 23 people in the first group and 21 in the second group had completed the study (two people in the second group did not finish). The reported data shows that, after 20 weeks, both groups had lower HbA1c readings than when they started. The first group (3-0-3) had an average reduction of 0.9 percentage points, and the second group (2-4-6-8) had an average reduction of 1.0 percentage point. At the 12-week mark, the reported reductions were 0.8 and 0.9 percentage points respectively. When looking at how many participants reached an HbA1c below 7.0% by the end of the trial, the reported data shows approximately 8.7% of people in the first group and 14.3% in the second group reached that level. Fasting blood sugar (a measure of blood glucose after not eating) also showed reductions in both groups across different measurement points, though the exact figures varied between the two measurement periods reported. The reported data also includes counts of low blood sugar episodes (called hypoglycaemia — when blood sugar drops too low). Over the full 24-hour period, 72 episodes were recorded in the first group and 119 in the second group. During overnight hours (11 pm to 6 am), 22 episodes were recorded in the first group and 17 in the second group. These are counts of episodes across all participants, not per person, and no further breakdown 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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NCT01481116 · results posted 1 June 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled around 2,450 people across three groups — roughly 820 in each — who were given either glimepiride (a commonly used diabetes tablet) or one of two doses of an investigational medicine called TAK-875 (25 mg or 50 mg). The trial was measuring changes in a blood sugar marker called HbA1c, which reflects average blood glucose levels over a few months, as well as body weight, and the proportion of participants who experienced low blood sugar (hypoglycaemia) over a period of up to two years. It is worth noting that the reported data shows zero participants listed as having "completed" the study, which may reflect that the trial was stopped early; no further explanation for this was included in the submitted data. The reported data shows that at the study's start, average HbA1c levels were similar across all three groups (around 8%). By week 78, average HbA1c had fallen by approximately 0.80 percentage points in the glimepiride group, 0.82 points in the TAK-875 25 mg group, and 0.98 points in the TAK-875 50 mg group. At week 104, figures for the glimepiride group were listed as "NA" (not available), while the TAK-875 25 mg group showed a reduction of about 1.03 points and the TAK-875 50 mg group showed a very small increase of 0.03 points. For body weight, the glimepiride group showed an average increase of about 1.24 kg from their starting weight, while the TAK-875 groups showed very small average decreases (less than a quarter of a kilogram). Regarding low blood sugar events, approximately 30.2% of participants in the glimepiride group recorded a hypoglycaemic event, compared with around 5.4% in the TAK-875 25 mg group and 5.3% in the TAK-875 50 mg group. Data for the outcome measuring the percentage of participants without hypoglycaemia who also achieved an HbA1c below 7% 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01734785 · results posted 18 April 2016
According to the results reported on ClinicalTrials.gov, this trial involved people with type 2 diabetes and tested two doses of a medicine called empagliflozin (10 mg and 25 mg) against a placebo (a dummy treatment with no active ingredient). The trial had two stages. In the first, open-label stage, 606 people received another diabetes medicine called linagliptin, though only 333 completed that stage and moved on. In the second, double-blind stage — where neither participants nor researchers knew who was getting which treatment — 333 people were randomly assigned: 112 to empagliflozin 10 mg, 111 to empagliflozin 25 mg, and 110 to placebo. The main thing being measured was a blood marker called HbA1c, which reflects average blood sugar levels over roughly three months, after 24 weeks of the double-blind treatment. The reported data shows the following changes in HbA1c over those 24 weeks: the empagliflozin 10 mg group saw an average decrease of 0.65 percentage points, the empagliflozin 25 mg group saw an average decrease of 0.56 percentage points, and the placebo group saw a small average increase of 0.14 percentage points. For fasting blood sugar (a blood glucose reading taken after an overnight fast, measured in mmol/L), the reported data shows average decreases of 1.46 mmol/L and 1.75 mmol/L for the 10 mg and 25 mg empagliflozin groups respectively, compared with an average increase of 0.34 mmol/L in the placebo group. Body weight changes were also measured: on average, the 10 mg group lost 3.06 kg, the 25 mg group lost 2.52 kg, and the placebo group lost 0.30 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01778049 · results posted 4 April 2016
According to the results reported on ClinicalTrials.gov, this trial involved two main stages. In the first, open-label stage (where everyone knew what medicine they were taking), 354 people received a 10 mg dose of empagliflozin and 355 received a 25 mg dose. In the second, double-blind stage (where neither participants nor researchers knew who was getting which medicine), participants were split into four groups depending on which dose they had been on: those who added linagliptin 5 mg, and those who added a placebo (a dummy pill with no active ingredient). Around 112–130 people started in each of these four groups. The trial was primarily measuring changes in a blood marker called HbA1c — a measure of average blood sugar levels over roughly three months — after 24 weeks of the double-blind treatment. The reported data shows the following changes in HbA1c over 24 weeks. Among participants who had been on the 10 mg empagliflozin dose, those who added linagliptin had an average HbA1c change of −0.53 percentage points, while those who added the placebo had an average change of −0.21 percentage points. Among participants who had been on the 25 mg empagliflozin dose, those who added linagliptin had an average change of −0.58 percentage points, compared with −0.10 percentage points for those who added the placebo. These numbers reflect averages across each group and do not tell us what any individual person experienced. For a secondary measure — fasting plasma glucose (a blood sugar reading taken after not eating overnight, measured in mmol/L) — the reported data shows that in the 10 mg empagliflozin group, those taking linagliptin had an average change of −0.44 mmol/L, while the placebo group had an average change of +0.21 mmol/L. In the 25 mg empagliflozin group, the linagliptin group had an average change of −0.68 mmol/L, and the placebo group had an average change of −0.24 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01407276 · results posted 3 December 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01407276) enrolled 49 people in total across eight groups. The study was divided into two parts. Part 1 compared people with mild, moderate, or severe kidney impairment (6 people in each group) against matched healthy volunteers (6 people in each comparison group). Part 2 looked at people with end-stage kidney disease who required haemodialysis (a machine-based kidney filtering treatment), again compared with healthy volunteers. The trial was measuring how the body handled a single dose of a drug called omarigliptin — specifically, how much of the drug got into the bloodstream, how quickly it peaked, and how quickly the body cleared it. All but one participant completed the study. The reported data shows the following patterns across the groups. For the measure of overall drug exposure in the blood over time (called AUC, essentially a running total of drug levels), the figures were higher in the kidney-impaired groups compared to their matched healthy volunteers: mild impairment 4,703 vs. 4,984; moderate impairment 5,785 vs. 4,312; severe impairment 6,467 vs. 4,143; and end-stage kidney disease 7,257–7,586 vs. 3,843 (units: nM·hr). For the peak drug level in the blood, the reported numbers were broadly similar across all groups, ranging from about 41 to 64 nM. The rate at which the body cleared the drug was reported as lower in the kidney-impaired groups — for example, 17.18 mL/min in the severe impairment group compared to 30.09 mL/min in their matched healthy volunteers, and similar patterns were seen across the other groups. The reported data also shows figures for how the drug was distributed through the body and its concentration at 168 hours (one week) after the dose. These numbers varied between groups, but no data appeared to be missing from what was submitted. These figures represent measurements taken from a small number of participants in a single-dose study, and the results describe how the drug behaved in the body under specific conditions 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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NCT01059799 · results posted 13 November 2015
According to the results reported on ClinicalTrials.gov, this trial compared two types of long-acting insulin — insulin degludec (IDeg, taken once daily) and insulin glargine (IGlar, taken once daily) — in people with diabetes. A total of 289 people were assigned to the IDeg group and 146 to the IGlar group. Of those who started, 258 and 136 respectively completed the 26-week study. The main thing being measured was a blood test called HbA1c, which reflects average blood sugar levels over roughly the past three months. Several secondary measures were also tracked, including the rate of low blood sugar episodes (hypoglycaemia) and self-measured blood glucose readings taken at nine points throughout the day. The reported data shows that after 26 weeks, HbA1c levels fell by an average of 1.24 percentage points in the IDeg group and 1.35 percentage points in the IGlar group. For low blood sugar episodes overall, the reported rate was 298 episodes per 100 patient-years in the IDeg group and 370 per 100 patient-years in the IGlar group (a "patient-year" is a way of accounting for how long all participants were in the study combined). For low blood sugar episodes occurring overnight (between midnight and 5:59 am specifically), the reported rate was 78 per 100 patient-years in the IDeg group and 124 per 100 patient-years in the IGlar group. The reported data shows that average self-measured blood glucose across nine daily time points was 8.2 mmol/L in the IDeg group and 8.0 mmol/L in the IGlar 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 ↗ · Linked publication on PubMed ↗
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NCT01515657 · results posted 4 September 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 participants across three groups, each of whom tried all three forms of aspirin in a different order (this is called a "crossover" design). The three forms tested were: PL2200 aspirin capsules, immediate-release (IR) aspirin tablets, and enteric-coated (EC) aspirin caplets. The trial was measuring how quickly each form of aspirin caused a specific chemical change in the blood — specifically, how long it took to reach 99% reduction in something called serum thromboxane, which is a marker researchers use to track how aspirin acts on platelets (tiny blood cells involved in clotting). Most participants completed all three stages, with a small number (two or three people) not finishing at various points. The reported data shows the following times to reach that 99% reduction point: PL2200 aspirin capsules took an average of approximately 12.4 hours, immediate-release aspirin tablets took approximately 16.7 hours, and enteric-coated aspirin caplets took approximately 48.6 hours. In plain terms, these numbers represent how many hours passed before each formulation reached that threshold level of the measured marker in the blood. No other 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01609582 · results posted 21 August 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01609582) enrolled 3,207 people in total — 1,603 in the placebo group and 1,604 in the fasiglifam 50 mg group. The trial was designed to measure cardiovascular outcomes, specifically tracking how long it took for participants to experience serious heart-related events such as a heart attack, stroke, death from a cardiovascular cause, or hospitalisation for chest pain (unstable angina). A second, related measure looked at a slightly narrower set of the same events, excluding the hospitalisation for chest pain. The reported data shows that no participants completed the trial — all 3,207 are recorded as "not completed." This strongly suggests the study was stopped before it finished. Consistent with this, the reported outcome data for both the primary and secondary cardiovascular event measures shows "NA" (not available) for both the placebo and fasiglifam groups, meaning no numerical results for these outcomes were reported to ClinicalTrials.gov. Because the trial did not run to completion, the time-to-first-event figures that the study was designed to produce were not reported. In plain terms, the reported data shows that the key questions this trial set out to answer — whether and how quickly serious heart events occurred in each group — cannot be answered from the numbers submitted here, as the data was not 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01647542 · results posted 19 August 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 393 people in total — 131 in each of three groups: one group received a placebo (a dummy treatment with no active ingredient), one received a 25 mg dose of a medicine called fasiglifam, and one received a 50 mg dose of fasiglifam. The trial was measuring changes in blood sugar control over 24 weeks in people with type 2 diabetes. It is worth noting that a large number of participants did not complete the study — around 72 to 76 people per group dropped out before the end. The reported data shows that the main thing being measured was a blood marker called HbA1c, which reflects average blood sugar levels over roughly three months (expressed as a percentage). At the start of the study, all three groups had similar HbA1c readings of around 7.9–8.0%. After 24 weeks, the placebo group's HbA1c rose slightly, by about 0.15 percentage points on average, while the 25 mg fasiglifam group's figure fell by about 0.67 points and the 50 mg group's fell by about 0.87 points. For a related measure — the proportion of participants whose HbA1c dropped below 7% — the reported figures were 20% in the placebo group, 42.7% in the 25 mg group, and 52.7% in the 50 mg group. The reported data also shows results for blood sugar measured after fasting and after consuming a sugary drink. Fasting blood sugar rose by about 15 mg/dL in the placebo group, while both fasiglifam groups saw it fall by around 20–21 mg/dL. For blood sugar measured two hours after the sugary drink, the placebo group rose by about 3.7 mg/dL, the 25 mg group fell by about 21.2 mg/dL, and the 50 mg group rose slightly by about 9.6 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01649297 · results posted 23 July 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 983 people across five groups to compare four different doses and dosing schedules of a medicine called empagliflozin against a placebo (a dummy treatment with no active ingredient) in people with type 2 diabetes. The four empagliflozin groups tested either 5 mg or 12.5 mg taken twice a day, or 10 mg or 25 mg taken once a day. The main thing the trial was measuring was a blood marker called HbA1c — a way of tracking average blood sugar levels over roughly three months — after 16 weeks of treatment. A secondary measure was fasting plasma glucose, which is a person's blood sugar level after not eating overnight. The reported data shows that all five groups, including the placebo group, had a reduction in HbA1c from their starting levels. The placebo group's average change was −0.22 percentage points. The four empagliflozin groups showed average changes ranging from −0.64 to −0.83 percentage points, with the 12.5 mg twice-daily group showing the largest reported reduction and the 10 mg once-daily group the smallest among the active treatment groups. For fasting blood sugar, the reported data shows the placebo group had an average change of −0.2 mg/dL, while the empagliflozin groups ranged from −17.6 to −27.7 mg/dL, again with the 12.5 mg twice-daily group showing the largest reported change. These numbers reflect averages across the study groups and do not tell us what any individual person experienced. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01499082 · results posted 23 April 2015
According to the results reported on ClinicalTrials.gov, this trial compared two insulin products — HOE901-U300 (a newer formulation) and Lantus (an established insulin) — in people with diabetes. A total of 404 people were assigned to HOE901-U300 and 403 to Lantus, with around 359 and 355 respectively completing the study. The trial's main goal was to measure any change in a blood marker called HbA1c (a measure of average blood sugar levels over roughly three months) after six months of treatment. The reported data shows that both groups had the same average reduction in HbA1c after six months — a decrease of 0.83 percentage points in each group. For a secondary measure looking at low blood sugar episodes overnight (called nocturnal hypoglycaemia — when blood sugar drops too low during sleeping hours), the reported data shows that 36.1% of participants in the HOE901-U300 group experienced at least one such episode from week 9 to the six-month mark, compared with 46.0% in the Lantus group. Roughly 40% of participants in each group reached an HbA1c below 7% by six months (39.6% for HOE901-U300 and 40.9% for Lantus). Fasting blood sugar levels (measured after not eating overnight) fell by an average of 1.29 mmol/L in the HOE901-U300 group and 1.38 mmol/L in the Lantus group. Pre-injection blood sugar readings and their variability (how much the readings fluctuated) showed similar small reductions in 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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NCT01422876 · results posted 2 April 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,363 adults with type 2 diabetes across ten treatment groups. Participants were split into two broad categories: those already taking the diabetes medicine metformin, and those who had not yet started any diabetes medicine ("treatment naive"). Each category was then divided into five groups testing different combinations or individual doses of two medicines — empagliflozin and linagliptin — over 52 weeks. The main thing the trial was measuring was the change in a blood marker called HbA1c (a percentage figure that reflects average blood sugar levels over roughly three months) after 24 weeks of treatment. The reported data shows that, for participants already on metformin, HbA1c changed by −1.19% in the empagliflozin 25 mg plus linagliptin group, −1.08% in the empagliflozin 10 mg plus linagliptin group, −0.62% in the empagliflozin 25 mg alone group, −0.66% in the empagliflozin 10 mg alone group, and −0.70% in the linagliptin alone group. For participants who had not previously taken diabetes medicine, the reported changes were −1.08%, −1.24%, −0.95%, −0.83%, and −0.67% for the same groups respectively. In all cases a negative number means the HbA1c level was lower at week 24 than at the start of the trial. The reported data also shows changes in fasting blood sugar levels (a single blood sugar reading taken after not eating) and body weight at 24 weeks. For the metformin background groups, fasting blood sugar changed by between −13 and −35 mg/dL, and body weight changed by between −0.69 kg and −3.18 kg. For the treatment-naive groups, fasting blood sugar changed by between −5.92 and −29.55 mg/dL, and body weight changed by between −0.78 kg and −2.74 kg. These are reported averages across each group and do not represent any one individual's experience. 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 ↗
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NCT00845182 · results posted 17 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people in total across three groups: 13 took pioglitazone (a diabetes tablet) alone, 15 took exenatide (a diabetes injection) alone, and 15 took both medicines together. The trial was measuring changes in body weight and a blood sugar marker called HbA1c — a measure of average blood sugar levels over roughly three months. Not everyone finished the trial: 10 people completed it in the pioglitazone group, 11 in the exenatide group, and 9 in the combination group. The reported data shows the following changes after treatment. For body weight, the pioglitazone-only group had an average change of 5.5 kg, the exenatide-only group had an average change of 2.4 kg, and the combination group had an average change of 2.7 kg. The data does not specify whether these were increases or decreases, so the direction of those changes is not clear from the figures provided. For HbA1c, the reported data shows an average decrease (reduction from their starting level) of 1.37 percentage points in the pioglitazone group, 1.09 percentage points in the exenatide group, and 1.91 percentage points in the combination group. For the secondary outcomes — which looked at things like insulin sensitivity, certain inflammation markers, fatty acids, and cholesterol levels — no numerical results were reported 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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NCT01915849 · results posted 6 February 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 14 participants across four groups, each receiving a different sequence of treatments. The study tested three different doses of a drug called LIK066 (15 mg, 50 mg, and 150 mg) compared to a placebo (a dummy treatment with no active ingredient). It was designed as a "crossover" trial, meaning each participant took each treatment one after another across four separate four-day periods. The main thing the trial was measuring was how much glucose (sugar) from a mixed meal was absorbed into the bloodstream after taking each dose of LIK066 or the placebo — this was tracked using a specialised tracer method. The reported data shows the results as a figure called "area under the curve," which is a way of adding up the total amount of meal-derived glucose appearing in the blood over a five-hour period after eating. On Day 1, the reported values were: 102 units for the 15 mg dose, 94 units for the 50 mg dose, 64 units for the 150 mg dose, and 98 units for the placebo. On Day 4, the reported values were: 110 units for the 15 mg dose, 118 units for the 50 mg dose, 112 units for the 150 mg dose, and 104 units for the placebo (units are micromoles per kilogram of fat-free body mass per minute, multiplied by hours). No secondary outcome measure data was included in the submitted results. The reported data shows a small number of participants (14 started, with 2 not completing the first period), so these numbers come from a very small group. No additional outcome data beyond the primary measure was reported in the submission reviewed 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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NCT01075282 · results posted 16 January 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 810 people across three groups to compare two doses of an investigational medicine called LY2189265 (1.5 mg and 0.75 mg) against insulin glargine, an existing injectable diabetes medicine. The trial ran for 78 weeks and was primarily measuring changes in a blood marker called HbA1c — a measure of average blood sugar levels over roughly three months — expressed as a percentage. Around 242–243 people in each LY2189265 group and 238 people in the insulin glargine group completed the study. The reported data shows that at the main 52-week measurement point, average HbA1c fell by 1.08 percentage points in the LY2189265 1.5 mg group, by 0.76 percentage points in the LY2189265 0.75 mg group, and by 0.63 percentage points in the insulin glargine group. At the earlier 26-week check the reported reductions were 1.16, 0.89, and 0.65 percentage points respectively, and at the final 78-week check they were 0.90, 0.62, and 0.59 percentage points. The reported data also shows the number of participants whose HbA1c fell below 7% by 52 weeks: 140 in the LY2189265 1.5 mg group, 99 in the LY2189265 0.75 mg group, and 80 in the insulin glargine group. Daily average blood sugar readings (measured eight times a day by participants themselves) also fell across all three groups at each time point, with reductions ranging from about 1.15 to 1.79 mmol/L depending on the group and time point. The reported data also includes results from two additional measurements — HOMA2-%B and HOMA2-%S — which are modelling tools researchers use to estimate how well the insulin-producing cells in the pancreas are functioning and how sensitive the body is to insulin, compared with a healthy reference population set at 100%. These were only reported for the two LY2189265 groups (not for insulin glargine). The reported data shows the beta-cell function score rose by approximately 30 percentage points in the 1.5 mg group and 25 percentage points in the 0.75 mg group at 52 weeks, with similar figures at 78 weeks; insulin sensitivity scores showed small decreases of around 2–4 percentage points in both groups at 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01611883 · results posted 17 December 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 152 people — 75 in the ezetimibe group and 77 in the placebo group. Nearly all of them completed the study (74 and 76 respectively, with just one person leaving each group early). The trial was measuring whether ezetimibe, a cholesterol-lowering medicine, had any effect on blood sugar control in people with diabetes, as well as on cholesterol levels. Measurements were taken at the start of the study and again after 24 weeks. The reported data shows that for the primary outcome — a blood sugar marker called HbA1c (a percentage that reflects average blood glucose over several months) — both groups saw a small rise from their starting levels after 24 weeks. The ezetimibe group's HbA1c rose by an average of 0.22 percentage points, while the placebo group's rose by 0.14 percentage points. For a separate blood sugar marker called glycoalbumin, both groups showed an average change of -0.02 percentage points — essentially no change from baseline. Fasting blood glucose (measured after an overnight fast) rose by an average of 6.6 mg/dL in the ezetimibe group and 11.4 mg/dL in the placebo group. For LDL cholesterol (often called "bad" cholesterol), the ezetimibe group showed an average reduction of about 22.8%, compared with a reduction of about 1.75% in the placebo group. The reported data also shows that 9.3% of participants in the ezetimibe group and 7.8% in the placebo group experienced a recorded worsening of their diabetes during the study. Additionally, 9.3% of those in the ezetimibe group and 5.2% in the placebo group had changes made to their diabetes medicines due to worsening diabetes 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01519674 · results posted 10 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 582 people across three treatment groups, all of whom were also taking the diabetes medication metformin. The three groups were: one taking a twice-daily insulin (called "BID + Met", 194 people); one taking a twice-daily insulin plus sitagliptin (another diabetes tablet) with metformin ("BID + Sita + Met", 195 people); and one taking a once-daily insulin plus sitagliptin with metformin ("OD + Sita + Met", 193 people). The trial ran for 24 weeks and was primarily measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly three months, expressed as a percentage. The reported data shows that after 24 weeks, all three groups had lower HbA1c readings than when they started. The twice-daily insulin plus metformin group had an average reduction of 1.27 percentage points; the twice-daily insulin, sitagliptin and metformin group had an average reduction of 1.51 percentage points; and the once-daily insulin, sitagliptin and metformin group had an average reduction of 1.15 percentage points. Looking at secondary measures, the reported data shows the proportions of participants who reached an HbA1c below 7.0% were approximately 49.7%, 59.8%, and 46.5% respectively across the three groups. For the stricter target of 6.5% or below, the figures reported were 30.6%, 40.7%, and 25.1%. Fasting blood sugar levels (measured after not eating overnight) also fell across all groups by between 1.90 and 2.03 mmol/L. Blood sugar rises after meals at breakfast and lunch were also recorded, with some variation between groups, but 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00829296 · results posted 5 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people in total — 34 in the nebivolol group and 36 in the metoprolol group — all of whom had both type 2 diabetes and high blood pressure. Of those, 29 in the nebivolol group and 32 in the metoprolol group completed the trial. The study was measuring how these two blood pressure medicines compared on several readings related to blood vessel function, particularly pressure measured closer to the heart (called "central" pressure) rather than at the arm. The reported data shows that for the main outcome — central systolic blood pressure (the top number in a blood pressure reading, measured near the heart) — the nebivolol group started at an average of 125.3 mmHg and finished at 121.6 mmHg, while the metoprolol group started at 127.8 mmHg and finished at 123.8 mmHg. For the secondary outcomes, pulse wave velocity (a measure of how stiff the arteries are, in metres per second) went from 6.48 to 6.3 in the nebivolol group and from 6.52 to 6.4 in the metoprolol group. The augmentation index (a measure of how much a reflected pressure wave adds to heart pressure, expressed as a percentage) went from 22.0% to 22.1% in the nebivolol group and from 26.2% to 24.6% in the metoprolol group. Pulse pressure amplification (a ratio comparing pressure at the heart to pressure at the arm) went from 0.77 to 0.83 in the nebivolol group and from 0.79 to 0.85 in the metoprolol group. No further breakdown of these figures — such as statistical comparisons between the two groups — was 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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NCT01584232 · results posted 20 October 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 361 people with type 2 diabetes — 181 in one group who received a medicine called LY2189265 (also known as dulaglutide) alongside their existing oral diabetes tablets, and 180 in a second group who received insulin glargine alongside their oral tablets. The trial ran for 26 weeks and was primarily measuring changes in a blood marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly three months. Most participants finished the study: 173 in the first group and 177 in the second. The reported data shows that, on average, HbA1c levels fell by 1.44 percentage points in the LY2189265 group and by 0.90 percentage points in the insulin glargine group from where they started. Looking at how many participants reached certain HbA1c targets by 26 weeks, the reported figures show that 51.1% of the LY2189265 group reached a level at or below 6.5%, compared with 24.0% of the insulin glargine group; and 71.3% versus 45.8% reached a level below 7.0%. For fasting blood glucose (a morning blood sugar reading taken before eating), both groups showed a reduction — about 34.3 mg/dL in the LY2189265 group and 37.8 mg/dL in the insulin glargine group. Body weight changed by an average of −0.48 kg (a slight decrease) in the LY2189265 group and +0.94 kg (a slight increase) in the insulin glargine group. The reported data also shows that 26.0% of participants in the LY2189265 group had at least one episode of low blood sugar (hypoglycaemia) over the 26 weeks, compared with 47.8% in the insulin glargine group. Blood sugar readings tracked at multiple points throughout the day (eight-point self-monitoring) showed reductions in both groups across most time points, with the reported figures 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01421459 · results posted 9 October 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 759 people in total — 379 assigned to receive LY2963016 (an insulin glargine biosimilar) plus other diabetes tablets, and 380 assigned to receive Lantus (the reference insulin glargine) plus other diabetes tablets. The trial ran for 24 weeks and was primarily measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly two to three months. Around 334 people in the LY2963016 group and 328 in the Lantus group completed the study. The reported data shows that, at 24 weeks, the average HbA1c level fell by approximately 1.29 percentage points in the LY2963016 group and approximately 1.34 percentage points in the Lantus group from where each group started. For the secondary outcomes, the reported data shows that body weight increased on average over 24 weeks — by about 1.91 kg in the LY2963016 group and about 2.18 kg in the Lantus group. Insulin antibody levels (a measure of how the immune system responds to the insulin) showed small average decreases in both groups across the study period. Blood sugar readings taken at seven points throughout the day were broadly similar between the two groups at 24 weeks, and the variability of fasting (morning, before-meal) blood sugar was also reported to be similar 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01191268 · results posted 8 October 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 884 adults across three groups: 295 people received the higher dose of a medicine called LY2189265 (1.5 mg), 293 received the lower dose (0.75 mg), and 296 received insulin glargine, an existing injectable diabetes medicine. The trial ran for 52 weeks and was primarily measuring changes in a blood marker called HbA1c — a measure of average blood sugar levels over roughly three months — with the main result recorded at 26 weeks. Around 237–244 participants in each group completed the full trial. The reported data shows that at 26 weeks, average HbA1c levels fell by 1.64 percentage points in the 1.5 mg LY2189265 group, 1.59 percentage points in the 0.75 mg group, and 1.41 percentage points in the insulin glargine group. At 52 weeks, the reported reductions were 1.48, 1.42, and 1.23 percentage points respectively. For a secondary measure looking at the proportion of participants whose HbA1c dropped below 7% without experiencing low blood sugar episodes overnight or severely (defined as needing another person's help), the reported figures at 26 weeks were 53.8% (1.5 mg group), 54.5% (0.75 mg group), and 28.2% (insulin glargine group); at 52 weeks these figures were 44.0%, 44.0%, and 26.8% respectively. Changes in fasting blood sugar and self-monitored daily blood sugar readings were also measured across both time points, with varying degrees of change reported across all 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01477567 · results posted 6 October 2014
According to the results reported on ClinicalTrials.gov, this trial tested a drug called LY3009385 in 40 people in total. Participants were split into seven groups — six groups each received a different dose of the drug (0.3 mg, 1 mg, 3 mg, 9 mg, 22 mg, or 54 mg), and one group received a placebo (a dummy treatment with no active ingredient). All 40 participants completed the study. The trial was an early-stage study primarily looking at unwanted side effects and also measuring how the drug moved through the body and whether it had any effect on blood sugar levels after a meal. The reported data shows that for the primary outcome — the number of people who experienced a side effect judged to be related to the study drug — the numbers were: 1 person in the 0.3 mg group, 1 in the 1 mg group, 1 in the 3 mg group, 2 in the 9 mg group, 5 in the 22 mg group, 5 in the 54 mg group, and 2 in the placebo group. No serious side effects (those involving hospitalisation, being life-threatening, or causing lasting harm) were reported in any group, according to the partial data available. For how much of the drug was measured in the blood, the reported figures rose with each higher dose — ranging from 4.81 to 1,670 micrograms×hours/mL for overall drug exposure, and from 14.1 to 4,810 nanograms/mL for peak blood levels. For blood sugar measured over six hours after a standardised meal, the reported changes from starting levels varied across groups, with the placebo group showing a small rise of 4.73 units and the 54 mg group showing the largest reported decrease of 108.93 units (in milligrams×hours/decilitre). Changes in c-peptide (a marker related to insulin) and glucagon (a hormone involved in blood sugar control) after the meal were also reported and varied across dose groups; some figures for certain groups were listed as not available 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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NCT01525225 · results posted 26 August 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01525225) enrolled 4 people in total, though only 2 went on to receive treatment and both of those completed the study. The trial involved participants taking a combination of two diabetes medications — metformin and saxagliptin — followed by a combined extended-release tablet containing both. The study was measuring things like unwanted health events (called adverse events), serious medical events, whether anyone stopped the study because of a health problem, and whether there were any unusual changes in blood test results. The reported data shows that of the 2 participants who were treated, 2 experienced at least one adverse event (an unwanted symptom or health change during the study), and 1 experienced a serious adverse event (a more significant medical event, as defined in the study). The reported data shows that no participants stopped the study early because of an adverse event, and no deaths were recorded. For the secondary outcome — looking at whether blood or chemistry test results showed notable abnormalities — the reported data shows that 0 out of the 2 treated participants had results flagged as markedly abnormal. It is worth noting that only 2 people received treatment in this trial, which is an extremely small number, meaning these figures give very limited information on their own. No other outcome data beyond what is described above 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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NCT01194245 · results posted 19 August 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 135 people to begin with. After an initial 4–6 week settling-in period, 117 participants moved on to the main part of the study, which was split into two 12-week treatment phases. The trial was comparing two experimental insulin formulations — called "Analog-PH20" (insulin lispro or insulin aspart, each combined with an enzyme called PH20 that may affect how quickly insulin is absorbed under the skin) — against standard insulin lispro alone. Participants alternated between the two types of insulin across the two treatment phases. The main thing the trial was measuring was any change in a blood-sugar control marker called HbA1c (a percentage that reflects average blood sugar levels over roughly three months). The reported data shows that for the primary measure — change in HbA1c from the start of the trial to the end of each treatment period — the Analog-PH20 group had an average change of −0.14 percentage points, while the standard insulin lispro group had an average change of −0.19 percentage points. For the secondary measures, the reported data shows the mean daily insulin dose was about 54 units for the Analog-PH20 group and about 56 units for the standard insulin group. Blood sugar rises after meals (measured at 1 and 2 hours after breakfast, lunch, and dinner) were generally reported as numerically lower in the Analog-PH20 group compared to the standard insulin group across most meal times. The percentage of participants whose blood sugar readings after meals stayed below two different target levels was reported as somewhat higher in the Analog-PH20 group than the standard insulin group. Low blood sugar episodes (defined as blood glucose at or below 70 mg/dL, and separately below 56 mg/dL) were recorded at roughly 18.96 versus 19.91 events per person per month, and 7.50 versus 8.05 events per person per month, respectively. Average body weight change was reported as −0.25 pounds for the Analog-PH20 group and +0.10 pounds for the standard insulin 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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NCT01060540 · results posted 4 August 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 601 people in total — 303 in one group (called CR+G) and 298 in another (called CR+EYE). Around 239 and 233 people respectively completed the study. The trial was measuring a range of things related to weight and lifestyle over a three-month period, including body weight, a marker related to how the body handles blood sugar (called insulin resistance), how participants rated their own risk of developing type 2 diabetes, how many calories they reported eating each day, and how much moderate-intensity physical activity they reported doing each week. The reported data shows that at three months, the CR+G group had an average weight of 103.8 kg, while the CR+EYE group averaged 100.7 kg. For insulin resistance — measured on a scale where higher numbers suggest the body is having more difficulty managing blood sugar — both groups recorded an average score of 4.1. When participants were asked to rate their own perceived lifetime risk of getting type 2 diabetes on a scale of 1 to 7, both groups averaged 3.1. The reported data shows that estimated daily calorie intake averaged 1,487 calories per day in the CR+G group and 1,573 in the CR+EYE group. For moderate physical activity, the CR+G group reported an average of 568 minutes per week, and the CR+EYE group reported 633 minutes per week. 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 ↗
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NCT02006836 · results posted 26 June 2014
According to the results reported on ClinicalTrials.gov, this trial involved two stages. In the first stage (months 1–6), 20 people with type 2 diabetes and 20 healthy people took part in a comparison study. In the second stage (months 7–12), 19 people with type 2 diabetes took part in a self-comparison study (meaning the same people were measured under two different conditions). The trial was looking at how eating Majia pomelo fruit affected blood sugar levels, including something called the Glycaemic Index (GI) — a score that indicates how quickly a food raises blood sugar compared to pure glucose, which is set at a score of 100. The reported data shows that in the first stage, the GI score for pomelo was measured at 76.79 in the group with diabetes and 86.92 in the healthy group, both measured as a percentage compared to the glucose reference score of 100. In the second stage, blood sugar rise after breakfast was reported as 2.93 mmol/L without pomelo and 3.61 mmol/L with pomelo; after lunch it was 1.39 mmol/L without pomelo and 2.87 mmol/L with pomelo; and after dinner it was 0.34 mmol/L without pomelo and 1.41 mmol/L with pomelo. The reported data also shows that the overall blood sugar level across the day (measured as a running total called area under the curve) was 164.04 mmol·hour/L without pomelo and 163.07 mmol·hour/L with pomelo — a very small numerical difference between the two conditions. These figures are the measurements the trial recorded and reported; they do not on their own tell us whether pomelo should or should not be part of anyone's diet, and no treatment recommendation can be drawn from them 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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NCT00789035 · results posted 18 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 406 people across five groups to compare three doses of a medicine called empagliflozin (5 mg, 10 mg, and 25 mg) against a placebo (a dummy treatment with no active ingredient) and an open-label comparison group taking metformin, another diabetes medicine. The trial ran for 12 weeks. The main thing being measured was a blood marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly three months. Most participants completed the trial, with between 74 and 81 people finishing in each group. The reported data shows that, at the end of 12 weeks, the placebo group's HbA1c changed by +0.09 percentage points from where it started (a very slight rise), while the empagliflozin groups showed changes of −0.43, −0.48, and −0.63 percentage points for the 5 mg, 10 mg, and 25 mg doses respectively. The metformin comparison group showed a change of −0.75 percentage points. For fasting blood sugar (a single blood glucose reading taken after an overnight fast, measured in mg/dL), the placebo group's level barely moved (+0.79 mg/dL), while the empagliflozin groups showed reductions of around 23, 29, and 31 mg/dL, and the metformin group around 30 mg/dL. Looking at the proportion of people who reached an HbA1c of 7.0% or below after 12 weeks, the reported figures were 22% for placebo, 33%, 30%, and 45% for the three empagliflozin doses, and 45% for the metformin group. For fasting insulin levels, small reductions from baseline were reported across all groups, ranging from roughly −0.01 to −1.02 mU/L, with no large differences 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00993824 · results posted 17 June 2014
According to the results reported on ClinicalTrials.gov, this trial involved 21 people with type 2 diabetes who were split into two groups. One group (11 people) took the medication Welchol first and then switched to a placebo (an inactive treatment), while the other group (10 people) took the placebo first and then switched to Welchol. All 21 participants completed the trial. The study was measuring blood sugar levels over time using a small device called a continuous glucose monitor (CGM), which tracks blood sugar automatically throughout the day and night across several two-week periods. The trial looked at overall blood sugar levels, overnight blood sugar levels, daytime blood sugar levels, and how often blood sugar dropped below a low threshold (below 70 mg/dL, which is considered a low blood sugar reading). The reported data shows that for overall blood sugar levels, the numbers ranged from around 149.9 to 177.9 units in the group that took Welchol first, and from around 159.4 to 175.9 units in the group that took placebo first, across the different measurement periods. For overnight blood sugar, the reported figures ranged from 147.4 to 172.0 units in the Welchol-first group, and from 143.6 to 161.9 units in the placebo-first group. For daytime blood sugar, figures ranged from 151.2 to 180.9 units in the Welchol-first group, and from 163.8 to 180.9 units in the placebo-first group. The reported data shows that the percentage of time blood sugar dropped below 70 mg/dL was low across both groups throughout the study, ranging from 0.3% to 1.2% at various 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00252694 · results posted 6 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 951 people in the candesartan group and 954 people in the placebo group — just over 1,900 participants in total. The trial was looking at eye disease in people with diabetes, specifically tracking whether changes occurred in the severity of diabetic retinopathy (damage to the back of the eye caused by diabetes) over time. It used a standardised 11-step scale to measure how much a person's eye condition changed, and also looked at the development of two serious eye complications — macular oedema (swelling near the centre of the eye) and proliferative diabetic retinopathy (growth of new, fragile blood vessels in the eye) — as well as changes in a urine measurement related to kidney function. The reported data shows that for the main (primary) outcome — the number of people whose eye condition worsened by three or more steps on the severity scale — 161 participants in the candesartan group and 182 in the placebo group met this threshold. For one of the secondary outcomes, measuring improvement of three or more steps (or a sustained two-step improvement), the reported numbers were 180 in the candesartan group and 136 in the placebo group. When it came to developing serious eye complications (macular oedema and/or proliferative diabetic retinopathy), the reported figures were very close: 192 in the candesartan group and 193 in the placebo group. For the kidney-related urine measurement, the reported average rate of change was 656 units in the candesartan group and 718 units in the placebo group (measured in log micrograms per minute per 1,000 years, a technical unit used to track very gradual changes over time). 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 ↗
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NCT01128894 · results posted 20 May 2014
According to the results reported on ClinicalTrials.gov, this trial compared two injectable diabetes medicines — albiglutide (50 mg) and liraglutide (1.8 mg) — in people with type 2 diabetes. A total of 404 people were assigned to the albiglutide group and 408 to the liraglutide group, making 812 participants in all. The trial ran for 32 weeks and its main focus was measuring changes in a blood marker called HbA1c — a reading that reflects average blood sugar levels over roughly two to three months. The reported data shows that by week 32, HbA1c levels had fallen on average by 0.78 percentage points in the albiglutide group and by 0.99 percentage points in the liraglutide group, compared to where each participant started. At earlier check-in points (weeks 4, 6, 12, 18, and 26), the reported data shows the liraglutide group consistently recorded larger average reductions in HbA1c than the albiglutide group at each time point. For fasting blood sugar (measured after not eating for 12–14 hours), the reported reduction at week 32 was 1.22 mmol/L for albiglutide and 1.68 mmol/L for liraglutide. When looking at how many participants reached specific HbA1c targets by week 32, the reported data shows 78 people in the albiglutide group and 113 in the liraglutide group reached below 6.5%, while 168 and 208 respectively reached below 7.0%. For the measure tracking time until a participant needed additional treatment for persistently high blood sugar, no summary figures 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01098539 · results posted 16 May 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01098539) enrolled 249 people in the albiglutide 30 mg group and 246 people in the sitagliptin 100 mg group — 495 participants in total. Both albiglutide and sitagliptin are medicines used in the management of type 2 diabetes. The trial was primarily measuring changes in a blood marker called HbA1c, which reflects average blood sugar levels over roughly two to three months. It also tracked fasting plasma glucose (FPG) — a measure of blood sugar after not eating for 12–14 hours — at multiple points over the course of the study, which ran to at least 26 weeks (with some measurements taken out to 52 weeks). Of those who started, 198 people in the albiglutide group and 178 in the sitagliptin group completed the trial. The reported data shows that, at the main 26-week measurement point, the albiglutide group's HbA1c percentage changed by an average of −0.83 percentage points from where it started, while the sitagliptin group's changed by an average of −0.52 percentage points (both figures representing reductions). For fasting blood sugar at week 26, the reported change from the starting point averaged −1.42 mmol/L in the albiglutide group and −0.22 mmol/L in the sitagliptin group. The reported data also shows that HbA1c readings were tracked at weeks 4, 8, 12, 16, and 20, with reductions in both groups increasing gradually over time in both the albiglutide and sitagliptin groups across all those time points. Where data was available out to 52 weeks, the observed reductions in HbA1c continued, with the albiglutide group recording an average change of −0.93 percentage points and the sitagliptin group −0.80 percentage points at that later point. It is worth noting that these numbers describe what was measured and recorded across the whole group — individual results within each group varied, and the data does not tell us how any single person responded. The reported data also does not include figures for all possible measurements within the submitted results, and where data was not reported for a specific time point or subgroup, no figure has been 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01512979 · results posted 9 May 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 316 people in total — 159 in a group taking linagliptin (5 mg) combined with metformin, and 157 taking linagliptin (5 mg) alone. The trial ran for 24 weeks and was primarily measuring changes in a blood marker called HbA1c, which reflects average blood sugar levels over roughly two to three months and is expressed as a percentage. By the end of the trial, 140 people in the combination group and 135 in the linagliptin-only group had completed the study. The reported data shows that, on average, HbA1c levels fell by 2.81 percentage points in the linagliptin plus metformin group and by 2.02 percentage points in the linagliptin-only group over the 24 weeks. For a separate blood sugar measure taken after an overnight fast (fasting plasma glucose, reported in mg/dL), the combination group showed an average drop of 47.1 mg/dL, while the linagliptin-only group showed an average drop of 30.2 mg/dL. Looking at how many individuals reached certain blood sugar targets, the reported data shows that 124 people in the combination group and 92 in the linagliptin-only group had their HbA1c drop by at least 0.5%; 116 versus 82 had it drop by at least 1.0%; and 81 versus 45 reached an HbA1c below 7.0% by week 24. 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 ↗
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NCT00974090 · results posted 8 May 2014
According to the results reported on ClinicalTrials.gov, this trial involved 194 people across two groups. One group (98 people) started on a dummy tablet (placebo) before switching to a combination of teneligliptin and a sulphonylurea medicine, while the other group (96 people) started on teneligliptin straight away before also moving to the combination. The trial ran in two back-to-back stages: a 12-week blinded period where participants did not know which treatment they were receiving, followed by an open-label period where everyone knew. The main thing the trial was measuring was a blood marker called HbA1c — a percentage that reflects average blood sugar levels over roughly two to three months. The reported data shows that after 12 weeks, the placebo group's HbA1c figure rose by an average of 0.29 percentage points from where it started, while the teneligliptin group's figure fell by an average of 0.71 percentage points. For fasting blood sugar (blood sugar measured after not eating overnight), the placebo group's level rose by about 9.8 mg/dL on average, whereas the teneligliptin group's level fell by about 17.3 mg/dL. The trial also tracked blood sugar after meals: two hours after eating, the placebo group's blood sugar rose by an average of 6.0 mg/dL, compared with a fall of 43.1 mg/dL in the teneligliptin group. A related measure of blood sugar over the two hours after a meal also rose in the placebo group and fell in the teneligliptin group, based on the reported figures. 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 ↗
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NCT01177384 · results posted 28 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 381 people — 191 in the sitagliptin group and 190 in the placebo group (a placebo is a dummy treatment with no active ingredient, used for comparison). By the end of the study, 177 people in the sitagliptin group and 164 in the placebo group had completed it. The trial was measuring changes in blood sugar control over 24 weeks, using a measure called HbA1c (a percentage that reflects average blood sugar levels over roughly three months) and fasting plasma glucose (a blood sugar reading taken after an overnight fast). The reported data shows that, at week 24, the sitagliptin group's HbA1c had changed by an average of −0.76 percentage points from where it started, while the placebo group's changed by an average of −0.14 percentage points. For fasting blood sugar levels, the reported data shows the sitagliptin group's readings changed by an average of −17.9 mg/dL (a unit of blood sugar concentration) from their starting point, compared with −3.5 mg/dL in the placebo group. The trial also tracked adverse events (unexpected or unwanted health events that occurred during the study). According to the results reported on ClinicalTrials.gov, 62 out of 191 participants in the sitagliptin group and 58 out of 190 in the placebo group experienced at least one adverse event. Five participants in the sitagliptin group and 2 in the placebo group stopped taking the study drug because of an adverse 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01786707 · results posted 21 April 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01786707) enrolled just 2 people in total — one person in the "Autologous Stem Cell and HOT" group and one person in the "Control Group." The trial was measuring changes in a blood sugar marker called HbA1c (a standard measure of average blood sugar levels over a few months) in people with diabetes. Specifically, it was looking at whether participants' HbA1c levels dropped by certain amounts over the course of the study. Notably, neither participant completed the trial. The reported data shows that for the primary outcome — the number of participants whose HbA1c fell by more than 0.5% — the result was zero in both groups. For the secondary outcome, which looked for an even larger drop of more than 1% in HbA1c, the reported result was again zero participants in both groups. Because no one completed the trial, these results reflect an extremely small and incomplete dataset. It is important to note that with only one person per group and no completions, the reported numbers cannot be used to draw any meaningful conclusions about the treatment 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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NCT01614769 · results posted 24 February 2014
According to the results reported on ClinicalTrials.gov, this was a small crossover trial — meaning each participant tried all three conditions in a different order — involving a total of 10 people who started the study across six sequence groups. Due to some participants not completing all stages, the number who contributed data to the final measurements was smaller. The trial was looking at how quickly blood sugar returned to a normal range after being deliberately lowered to a hypoglycaemic (low blood sugar) level, and comparing this under three conditions: a placebo (inactive treatment), a 2 mg dose of glimepiride (a diabetes medication), and a 4 mg dose of glimepiride. The reported data shows three main measurements. First, the time taken for blood sugar to recover to a normal level: under placebo this was reported as approximately 74 minutes, under the 2 mg glimepiride dose it was approximately 89 minutes, and under the 4 mg dose it was approximately 110 minutes. Second, the speed of that recovery (how fast blood sugar was rising per minute): placebo was reported at 0.32 mg/dL per minute, the 2 mg dose at 0.22 mg/dL per minute, and the 4 mg dose at 0.19 mg/dL per minute. Third, the overall average rise in blood sugar across the three-hour recovery window: placebo was reported at approximately 22.6 mg/dL, the 2 mg dose at approximately 17.6 mg/dL, and the 4 mg dose at approximately 15.3 mg/dL. It is worth noting that this was a very small study, and no outcome data beyond these figures 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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NCT00998881 · results posted 21 February 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT00998881) enrolled 203 adults with type 2 diabetes — 104 in the placebo group and 99 in the teneligliptin 20 mg group. 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, expressed as a percentage) after 12 weeks. The trial also tracked fasting blood sugar levels (measured after not eating overnight) and blood sugar levels after a meal. The reported data shows that after 12 weeks, the HbA1c figure in the placebo group went up by an average of 0.17 percentage points from where it started, while in the teneligliptin group it went down by an average of 0.62 percentage points. For fasting blood sugar, the placebo group showed almost no change (down 0.2 mg/dL), whereas the teneligliptin group showed a reduction of 19.2 mg/dL on average. When looking at blood sugar levels after a meal, the teneligliptin group showed a reduction of 47.9 mg/dL at the two-hour mark, compared with a reduction of 3.2 mg/dL in the placebo group. A related measure of how much sugar was in the blood over the two hours after eating also showed a larger reduction in the teneligliptin group (down 73.1 units) compared with virtually no change in the placebo group (up 0.2 units). These figures are statistical averages adjusted to account for where each group started. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01541735 · results posted 21 February 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 14 people in total — 7 in a group that received pantoprazole (a medication commonly used for stomach acid) and 7 in a group that received a placebo (a dummy treatment with no active ingredient). All 14 participants completed the trial with no drop-outs. The trial was measuring how the body releases insulin — a hormone that controls blood sugar — across different phases, as well as a blood sugar marker called HbA1c (a measure of average blood sugar levels over the previous few months). The reported data shows that for the first phase of insulin release, the pantoprazole group recorded an average of 13.8 µU/ml (a unit measuring insulin in the blood), compared with 15.9 µU/ml in the placebo group. For the second phase of insulin release, the pantoprazole group recorded 35.9 µU/ml versus 38.4 µU/ml in the placebo group. For total insulin secretion, the pantoprazole group recorded 29.0 µU/ml compared with 31.5 µU/ml in the placebo group. For the HbA1c blood sugar marker, the pantoprazole group recorded an average of 7.5% versus 7.8% in the placebo group. These numbers represent averages across a very small number of participants, and no further statistical detail (such as whether these differences were considered meaningful) 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01237301 · results posted 6 January 2014
According to the results reported on ClinicalTrials.gov, this trial involved 124 adults with diabetes who were split into two groups. Sixty-five people were assigned to use a continuous glucose monitor (CGM — a small wearable device that checks blood sugar levels automatically throughout the day), and 59 were assigned to use standard self-monitored blood glucose testing (SMBG — the traditional finger-prick method). By the end of the study, 60 people in the CGM group and 55 in the SMBG group had completed it. The trial was measuring changes in HbA1c (a blood test that reflects average blood sugar levels over roughly three months), as well as several other blood sugar-related measures. The reported data shows that both groups had a reduction in their HbA1c over the course of the trial. The CGM group's HbA1c fell by an average of 1.12 percentage points, while the SMBG group's fell by an average of 0.82 percentage points. For the secondary measures, the reported data shows reductions in overall glucose exposure (a measure of how much sugar was circulating over the day) in both groups — a change of approximately −616 units in the CGM group and −523 units in the SMBG group. Blood sugar variability (how much levels fluctuated) also decreased in both groups, with the CGM group showing a change of −8.36 mg/dL and the SMBG group −5.91 mg/dL. For time spent in a very low blood sugar range (below 50 mg/dL), the CGM group showed a small decrease of −0.42%, while the SMBG group showed a small increase of 0.14%. 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 ↗
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NCT00674986 · results posted 21 October 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT00674986) enrolled 499 people with diabetes — 230 in the Active Control Group (ACG) and 269 in the Structured Testing Group (STG). The trial compared two approaches to blood sugar monitoring: a structured testing approach versus standard active monitoring. The main thing being measured was a blood marker called HbA1c, which gives an indication of average blood sugar levels over the previous few months. The trial also measured several other things, including depression, diabetes-related distress, general wellbeing, and confidence in managing diabetes day-to-day. By the end of the 12-month trial, 187 participants in the ACG and 188 in the STG had completed the study. The reported data shows that, for the main outcome, HbA1c levels changed from the starting point by minus 0.88 percentage points in the ACG and minus 1.16 percentage points in the STG (a negative number means the level went down). For the secondary outcomes, doctors made an average of 1.1 visits with medication or lifestyle change recommendations per person in the ACG, compared to 2.7 in the STG. On the depression questionnaire (scored 0–24, lower is better), scores changed by minus 1.1 in the ACG and minus 1.7 in the STG. On the diabetes distress scale (scored 1–6, lower is better), scores changed by minus 0.40 in the ACG and minus 0.55 in the STG. For general wellbeing (scored 0–100, higher is better), scores changed by plus 4.1 in the ACG and plus 7.4 in the STG. For confidence in self-care (scored 20–100, higher is better), scores changed by plus 2.7 in the ACG and plus 5.8 in the STG. 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 ↗
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NCT00509223 · results posted 17 October 2013
According to the results reported on ClinicalTrials.gov, this trial involved 416 people split across two groups — 207 in Group 1 and 209 in Group 2. By the end of the study, 119 people in Group 1 and 137 people in Group 2 had completed it, meaning a notable number of participants did not finish in both groups. The trial was measuring a value called HbA1c, which is a blood test that reflects average blood sugar levels over roughly three months, and specifically looked at how much that value changed over six months. The reported data shows that both groups had the same average change in their HbA1c reading after six months: a decrease of 0.1 percentage points. One group received lifestyle counselling combined with PAP therapy (a breathing-support treatment), while the other received lifestyle counselling alone. Both groups' HbA1c results moved by the same small amount according to the figures submitted. It is worth noting that only one outcome measure — the HbA1c change — was included in the structured results data provided to ClinicalTrials.gov for this trial. No secondary outcome measure data was reported in the submission reviewed here, so those figures cannot be described. 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 ↗
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NCT01087502 · results posted 17 October 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 241 people in total — 123 in the placebo/glimepiride group and 118 in the linagliptin 5 mg group. The trial was measuring changes in blood sugar control in people with type 2 diabetes over 52 weeks. The main thing being tracked was a blood test called HbA1c, which gives an average picture of blood sugar levels over the previous few months and is expressed as a percentage — a lower number generally indicates lower average blood sugar. A shorter check-in was done at 12 weeks, and a final analysis was done at 52 weeks. By the end of the full 52 weeks, 90 people in the placebo/glimepiride group and 95 in the linagliptin group had completed the trial. The reported data shows that at the 12-week point (the main measurement the trial was designed around), the placebo group's HbA1c had changed by an average of −0.11 percentage points from where it started, while the linagliptin group's had changed by an average of −0.53 percentage points. For fasting blood sugar (a separate blood test taken after not eating overnight, measured in mg/dL), the reported change at 12 weeks was +9.53 mg/dL in the placebo/glimepiride group and +0.24 mg/dL in the linagliptin group. The reported data also shows that at 12 weeks, about 11.8% of people in the placebo/glimepiride group and 22.1% in the linagliptin group had an HbA1c reading below 7.0%; by week 52, those figures were 9.1% and 19.4% respectively. For a lower threshold of below 6.5%, the reported figures were 6.7% (placebo/glimepiride) and 9.9% (linagliptin) at week 12, and 5.0% and 6.1% at week 52. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00984867 · results posted 14 October 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 451 adults with type 2 diabetes — 226 received a placebo and 225 received dapagliflozin. All participants were already taking a diabetes medicine called sitagliptin, either on its own or combined with metformin, but their blood sugar was not adequately controlled. The trial ran for 24 weeks and mainly looked at changes in a blood sugar measure called HbA1c (a percentage that reflects average blood sugar levels over roughly three months). It also tracked body weight, fasting blood sugar (a reading taken after not eating overnight), blood pressure, and blood sugar levels after a test meal. The reported data shows that for the main measurement — change in HbA1c after 24 weeks — the placebo group's reading increased by an average of 0.04 percentage points, while the dapagliflozin group's reading decreased by an average of 0.45 percentage points. Among participants whose HbA1c was 8% or higher at the start, the reported change was a 0.03 point increase in the placebo group and a 0.80 point decrease in the dapagliflozin group. For body weight, the placebo group lost an average of 0.26 kg and the dapagliflozin group lost an average of 2.14 kg. Fasting blood sugar (measured in mg/dL, a standard unit for blood glucose) rose by 3.81 in the placebo group and fell by 24.11 in the dapagliflozin group. Blood sugar measured two hours after a test meal fell by 6.84 in the placebo group and by 21.65 in the dapagliflozin group. For seated systolic blood pressure (the top number in a blood pressure reading) in participants who started with a reading of 130 mmHg or above, the placebo group fell by 5.12 mmHg and the dapagliflozin group fell by 5.98 mmHg — both measured at week 8. 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 ↗
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NCT00639457 · results posted 12 September 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 44 adults in total — 22 in each group. One group took a medicine called pioglitazone on its own, while the other group took pioglitazone combined with a structured exercise programme. The trial was primarily measuring how well the body responded to insulin — specifically, how much glucose (sugar) the body's tissues took up when insulin was present. A number of secondary measurements were also taken, including the amount of fat stored around the abdomen and liver, the liver's ability to respond to insulin, and blood fat levels. Twenty people in the pioglitazone-only group and 19 in the combination group completed the trial. The reported data shows that, for the main measurement (insulin-stimulated glucose uptake by the body's tissues), the pioglitazone-only group started at around 30 units and ended at around 37 units, while the pioglitazone-plus-exercise group started at around 34 units and ended at around 48 units. For the secondary measurements, the reported data shows that visceral fat (deep belly fat) went from roughly 1,933 cm³ to 1,970 cm³ in the pioglitazone-only group, and from 1,890 cm³ to 1,746 cm³ in the combination group. Fat stored just under the skin of the abdomen went from about 2,101 cm³ to 2,164 cm³ in the pioglitazone-only group, and from 1,877 cm³ to 1,905 cm³ in the combination group. Fat content in the liver (measured as a percentage relative to water) went from 12.1% to 10.7% in the pioglitazone-only group, and from 8.0% to 5.5% in the combination group. The liver's ability to respond to insulin (measured as how much it could reduce its own glucose output when insulin was present) went from 32% to 40% in the pioglitazone-only group, and from 37% to 42% in the combination group. Blood fat levels were also reported across both groups, with the numbers showing modest changes across the course of the trial in both groups; however, the specific blood fat subtypes (e.g. triglycerides, cholesterol) were not individually labelled in the submitted data, so a more detailed breakdown cannot 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01473953 · results posted 4 September 2013
According to the results reported on ClinicalTrials.gov, this trial tested four different doses of an experimental slow-release injection called "liraglutide-depot" (2.25 mg, 6.75 mg, 15 mg, and 30 mg) compared with a dummy (placebo) injection. A total of 31 people started the trial — six in each of the three lower-dose groups, five in the highest-dose group, and eight in the placebo group. Thirty of those 31 people finished the trial; one person in the lowest-dose group did not complete it. The trial was mainly measuring how many unwanted medical events (called adverse events) occurred, and also tracking how the drug moved through the body after a single injection. The reported data shows that the primary outcome — counting unwanted medical events that emerged during treatment — recorded 3 events in the 2.25 mg group, 3 in the 6.75 mg group, 4 in the 15 mg group, 21 in the 30 mg group, and 13 in the placebo group. No events were recorded as moderate or severe in any group based on the figures provided. For the secondary outcomes, the reported data shows that the highest level of the drug detected in the blood (peak concentration) rose with each higher dose: 690 units (pmol/L) at 2.25 mg, 2,141 at 6.75 mg, 6,977 at 15 mg, and 40,041 at 30 mg. No placebo figure was reported for these measures, which is expected as the placebo contained no active drug. The time it took to reach that peak ranged from around 8 to 15 hours across the four dose groups. Measures of the total amount of drug in the blood over time also increased with each higher dose. The outcome looking at drug levels in participants who had received a pre-treatment dose of liraglutide was not 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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NCT01042977 · results posted 23 August 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 482 people in the dapagliflozin (a diabetes medication) group and 483 people in the placebo (dummy pill) group — just under 1,000 participants in total. All participants had type 2 diabetes as well as existing heart or blood vessel disease. The trial ran for 24 weeks and was measuring changes in three main things: blood sugar control (using a measure called HbA1c, which reflects average blood sugar levels over roughly three months), body weight, and seated systolic blood pressure (the top number in a blood pressure reading). The reported data shows that, on average, HbA1c levels changed by −0.33 percentage points in the dapagliflozin group compared with +0.07 percentage points in the placebo group, from the start of the trial to week 24. For the second primary measure — the proportion of participants who met all three targets at once (a drop of at least 0.5 percentage points in HbA1c, at least 3% reduction in body weight, and at least 3 mmHg drop in systolic blood pressure) — the reported figures were 10.0% of participants in the dapagliflozin group versus 1.9% in the placebo group. On the secondary measures, average body weight changed by −2.53% in the dapagliflozin group versus −0.61% in the placebo group. Among participants who started with a body mass index of 27 or above, 18.4% in the dapagliflozin group versus 4.8% in the placebo group were reported to have lost 5% or more of their body weight. Seated systolic blood pressure at week 24 changed by an average of −2.70 mmHg in the dapagliflozin group compared with +0.32 mmHg 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01106625 · results posted 29 May 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 469 adults across three groups: 156 received a placebo (a dummy treatment with no active ingredient), 157 received a 100 mg daily dose of canagliflozin, and 156 received a 300 mg daily dose of canagliflozin. The trial ran in two stages — a 26-week core period and a further 26-week extension to week 52. The main thing being measured was the change in HbA1c (a blood test that reflects average blood sugar levels over roughly three months) from the start of the trial to week 26. A number of secondary measurements were also taken, including fasting blood sugar levels, body weight, blood pressure, and blood fats called triglycerides. The reported data shows that, by week 26, the average HbA1c change was −0.13% in the placebo group, −0.85% in the 100 mg canagliflozin group, and −1.06% in the 300 mg canagliflozin group. For the secondary outcomes, the proportion of participants whose HbA1c fell below 7% at week 26 was reported as 18% (placebo), 43.2% (100 mg), and 56.6% (300 mg). Fasting blood sugar changed by +4.11 mg/dL in the placebo group, −18.2 mg/dL in the 100 mg group, and −30.5 mg/dL in the 300 mg group. Body weight changed by −0.7%, −2.1%, and −2.6% respectively. Systolic blood pressure (the top number in a blood pressure reading) changed by −2.65 mmHg, −4.89 mmHg, and −4.27 mmHg. Triglyceride (a type of fat in the blood) levels changed by +11.6%, +5.4%, and +8.5% 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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NCT01137812 · results posted 17 May 2013
According to the results reported on ClinicalTrials.gov, this trial compared two diabetes medications — canagliflozin 300 mg and sitagliptin 100 mg — in 755 people (377 in the canagliflozin group and 378 in the sitagliptin group). The main thing the trial was measuring was the change in a blood sugar marker called HbA1c (a percentage that reflects average blood sugar levels over roughly three months) after 52 weeks. A number of secondary things were also tracked, including the proportion of participants who reached an HbA1c below 7%, changes in fasting blood sugar levels, body weight, systolic blood pressure (the "top" number in a blood pressure reading), and triglycerides (a type of fat found in the blood). Not everyone finished the trial — 254 people in the canagliflozin group and 210 in the sitagliptin group completed it. The reported data shows that, on average, HbA1c changed by −1.03 percentage points in the canagliflozin group and −0.66 percentage points in the sitagliptin group over 52 weeks. These figures are described as "least-squares mean" changes, which is simply a statistical way of estimating the average while accounting for differences between participants. For the secondary measures, the reported data shows that 47.6% of the canagliflozin group and 35.3% of the sitagliptin group had an HbA1c below 7% at week 52. Fasting blood sugar levels changed on average by −29.9 mg/dL in the canagliflozin group compared with −5.85 mg/dL in the sitagliptin group. Body weight changed by an average of −2.5% in the canagliflozin group and +0.3% in the sitagliptin group. Systolic blood pressure changed by an average of −5.06 mmHg in the canagliflozin group and +0.85 mmHg in the sitagliptin group. Triglycerides changed by an average of +9.6% in the canagliflozin group and +11.9% in the sitagliptin 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 ↗ · Linked publication on PubMed ↗
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NCT01770483 · results posted 17 April 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 66 people in total — 33 in a control group and 33 in a study group. All 66 participants completed the trial with no drop-outs. The trial was looking at two things: first, whether the hepatitis C virus was undetectable in participants' blood six months after finishing treatment (called a "sustained viral response"); and second, whether a liver blood test called ALT (alanine transferase, a marker that can indicate liver inflammation) returned to a normal range. The reported data shows that for the main measure — the virus being undetectable six months after treatment ended — 13 out of 33 participants in the control group and 11 out of 33 participants in the study group reached this result. For the secondary measure — the ALT liver blood test returning to normal — 11 out of 33 participants in the control group and 11 out of 33 participants in the study group reached this result. The reported data shows the numbers were similar across both groups for the liver test, and fairly close for the main viral measure as well. It is worth noting that the trial results as submitted do not include additional context about the treatments each group received or other details that might help interpret these figures, so the numbers above are presented as reported without further interpretation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00328627 · results posted 4 April 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,554 people across twelve groups. All participants had type 2 diabetes and were already taking metformin. The trial tested different combinations of two medicines — alogliptin (at 12.5 mg or 25 mg doses) and pioglitazone (at 15 mg, 30 mg, or 45 mg doses) — alongside placebo (dummy) pills, to see how each combination affected a blood sugar marker called HbA1c. HbA1c is a measure of how much sugar has been attached to red blood cells over roughly the past three months, expressed as a percentage — a lower number generally reflects lower average blood sugar levels over that period. The reported data shows that the main thing being measured was the change in HbA1c from the start of the trial to 26 weeks later. For this primary measure, results were grouped together across all pioglitazone dose levels. The group receiving pioglitazone alone (no alogliptin) showed an average change of −0.89 percentage points. The group receiving alogliptin 12.5 mg combined with pioglitazone showed an average change of −1.43 percentage points, and the group receiving alogliptin 25 mg combined with pioglitazone showed an average change of −1.42 percentage points. The reported data also shows measurements taken at earlier time points (weeks 4, 8, 12, and 16), where all groups showed a trend of increasing change from baseline over time, with the combination groups consistently recording larger numerical changes than the pioglitazone-alone group at each point. Results for the placebo-only group (no active medicine) were also reported at each time point, with a change of −0.22 percentage points at week 4 through to −0.27 percentage points at week 16. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00069784 · results posted 25 January 2013
According to the results reported on ClinicalTrials.gov, this trial (known as ORIGIN) enrolled 12,537 people in total — 6,264 assigned to receive insulin glargine (a long-acting insulin) and 6,273 assigned to standard care. Participants had either type 2 diabetes, or blood sugar levels that were higher than normal but not yet at diabetes level (sometimes called "pre-diabetes"). The trial was measuring whether insulin glargine made any difference to serious heart and blood vessel events, kidney and eye complications, and — for those without diabetes at the start — whether they went on to develop type 2 diabetes. The reported data shows that for the main heart-related outcome (a combined count of cardiovascular death, non-fatal heart attack, or non-fatal stroke), 1,041 participants in the insulin glargine group and 1,013 in the standard care group experienced one of these events. For a broader heart-related outcome that also included procedures to restore blood flow and hospital admissions for heart failure, the reported figures were 1,792 (insulin glargine) and 1,727 (standard care). For deaths from any cause, 951 people in the insulin glargine group and 965 in the standard care group died. For kidney or eye complications combined, 1,323 (insulin glargine) and 1,363 (standard care) participants experienced at least one such event. Among participants who did not have diabetes at the start of the trial, 24.7% in the insulin glargine group and 31.2% in the standard care group were reported to have developed type 2 diabetes by the end of the study. Regarding low blood sugar episodes (hypoglycaemia), the reported data shows that 3,597 participants in the insulin glargine group and 1,624 in the standard care group experienced symptomatic episodes of any kind, with severe episodes (requiring another person's help) reported in 352 and 113 participants 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01383356 · results posted 24 January 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 58 people in total — 29 in each group. It was a crossover study, meaning participants took both treatments but in a different order, with a washout period of at least 35 days in between to clear the first treatment from the body. The trial was measuring how the body absorbs the diabetes medicine metformin when it is taken as a single combination tablet (linagliptin/metformin 2.5 mg/500 mg) compared to taking linagliptin and metformin as two separate tablets at the same time. By the end of the study, 44 of the 58 participants had completed both treatment periods. The reported data shows the results in terms of two key absorption measures for metformin in the blood. The first is the peak level of metformin detected in the blood: for the combination tablet this was reported as 901.82 ng/ml (nanograms per millilitre, a measure of concentration), compared to 770.52 ng/ml for the two separate tablets. The second measure looked at the total amount of metformin absorbed over time (up to the last measurable point): the combination tablet showed a value of 7,079.65 ng·h/ml, while the two separate tablets showed 6,808.27 ng·h/ml. A secondary measure extended this absorption calculation to cover the full timeframe beyond the last measurement, giving 7,198.79 ng·h/ml for the combination tablet and 6,923.79 ng·h/ml for the separate tablets. The reported data shows that both the peak blood level and overall absorption figures were numerically higher for the combination tablet compared to the two separate tablets, though what this difference means clinically is not described in the submitted results. No conclusions about whether one form is better or safer than the other should 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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NCT00757601 · results posted 7 September 2012
According to the results reported on ClinicalTrials.gov, this trial (NCT00757601) enrolled 25 participants across 12 groups. It was a dose-escalation study, meaning participants received increasing single doses of an investigational medicine called MK1006 (ranging from 15 mg up to 260 mg), a placebo (inactive treatment), or MK1006 taken with food. The trial was designed to track any unwanted changes participants experienced, and to measure how the medicine moved through the body — including how much of it reached the bloodstream, how quickly it peaked, and how long it took for levels to fall. The reported data shows that, for the primary outcome of unwanted events (called adverse events), the numbers of participants who experienced them across the dose groups ranged from 1 to 5 out of the small number of people in each group. The data for the placebo group figure was not reported in the submitted results. For the secondary outcome, the reported data shows that as the dose increased from 15 mg to 260 mg, the total amount of medicine measured in the blood over time generally rose — from around 595 units at the lowest dose to around 11,460–11,670 units at the highest doses. The peak blood level of the medicine also generally increased with dose, from about 60 units at 15 mg to around 1,174 units at 230 mg. The time it took to reach that peak ranged from about 1.5 to 5 hours depending on the dose. The reported half-life — meaning the time for blood levels to drop by half — ranged from approximately 17 to 31 hours across the different doses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00553787 · results posted 6 September 2012
According to the results reported on ClinicalTrials.gov, this trial (NCT00553787) enrolled 2,487 people across three groups: 994 received a placebo (a dummy treatment with no active ingredient), 498 received a middle dose of a medicine called VI-0521, and 995 received a higher dose of VI-0521. The trial ran for 56 weeks and was measuring changes in body weight over that time. Not everyone finished the trial — around 1,723 people completed it across the three groups. The reported data shows two main things that were measured. First, the average percentage of body weight lost from the start to week 56: the placebo group lost an average of 1.24% of their body weight, the middle-dose VI-0521 group lost an average of 7.81%, and the higher-dose VI-0521 group lost an average of 9.84%. Second, the proportion of participants who lost at least 5% of their body weight by week 56: this was 20.8% of people in the placebo group, 62.1% in the middle-dose group, and 70% in the higher-dose group. These figures used a method called "last observation carried forward" (meaning that if someone dropped out early, their last recorded measurement was used in the calculation). 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 ↗
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NCT01128153 · results posted 3 August 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 129 people in the saxagliptin group and 128 people in the placebo group (a placebo is a dummy treatment with no active ingredient). The trial ran for 24 weeks and was primarily measuring changes in a blood marker called HbA1c — a test that gives an indication of average blood sugar levels over roughly the previous two to three months. Participants who did not finish the full 24 weeks still had their last recorded measurement included in the analysis, using a method called "last observation carried forward." The reported data shows that, on average, the HbA1c level fell by 0.74 percentage points in the saxagliptin group, compared with a fall of 0.08 percentage points in the placebo group, over the 24-week period. For blood sugar measured two hours after a meal, the saxagliptin group showed an average decrease of about 0.65 mmol/L, while the placebo group showed a small average increase of 0.28 mmol/L. For fasting blood sugar (measured before eating), the saxagliptin group showed an average decrease of 0.29 mmol/L, compared with a small average increase of 0.15 mmol/L in the placebo group. The reported data also shows that 39 out of 127 participants in the saxagliptin group, and 12 out of 128 in the placebo group, reached an HbA1c level below 7% by week 24. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01084005 · results posted 18 July 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 241 people in total — 79 received a placebo (a dummy treatment with no active ingredient) and 162 received a daily 5 mg dose of linagliptin, a type 2 diabetes medication. The trial ran for 24 weeks and was primarily measuring changes in HbA1c — a blood test that reflects average blood sugar levels over roughly three months, expressed as a percentage. Most participants completed the trial: 74 in the placebo group and 146 in the linagliptin group. The reported data shows that the main result — the change in HbA1c after 24 weeks — was +0.04 percentage points in the placebo group (meaning their average stayed roughly the same) and −0.61 percentage points in the linagliptin group (meaning their average was somewhat lower than when they started). At earlier check-in points, the reported data shows similar patterns: at 6 weeks the changes were −0.07 (placebo) and −0.42 (linagliptin); at 12 weeks, −0.03 (placebo) and −0.60 (linagliptin); and at 18 weeks, +0.04 (placebo) and −0.58 (linagliptin). The trial also measured fasting blood sugar (a single blood glucose reading taken after an overnight fast, in units called mg/dL). At 24 weeks, the reported change was +10.1 mg/dL in the placebo group and −10.6 mg/dL in the linagliptin group. At 6 weeks, those figures were +4.6 mg/dL (placebo) and −14.1 mg/dL (linagliptin). 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 ↗
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NCT00641056 · results posted 4 July 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 233 people in the exenatide once-weekly group and 234 people in the insulin glargine group — 467 participants in total. The trial was measuring changes in blood sugar control over 26 weeks (roughly six months) in people with type 2 diabetes, comparing a once-weekly injectable medicine called exenatide with a daily injectable insulin called insulin glargine. The main thing being measured was a blood test called HbA1c, which gives an average picture of blood sugar levels over the previous two to three months. By the end of the study, 204 participants in the exenatide group and 209 in the insulin glargine group had completed it. The reported data shows that, on average, HbA1c levels fell by 1.47 percentage points in the exenatide once-weekly group and by 1.31 percentage points in the insulin glargine group from the start of the trial to week 26. Among participants whose HbA1c was above 7.0% at the start, 62.2% in the exenatide group and 54.1% in the insulin glargine group were reported to have reached an HbA1c at or below 7.0% by week 26. For the target of 6.5% or below, the reported figures were 43.2% and 28.4% respectively. The reported data also shows that fasting blood sugar levels (a single blood sugar reading taken after not eating) fell by 2.13 mmol/L in the exenatide group and by 2.76 mmol/L in the insulin glargine group. Body weight was reported to have changed by an average of −2.63 kg (a decrease) in the exenatide group and +1.42 kg (an increase) in the insulin glargine group. Total cholesterol was reported to have changed by −0.12 mmol/L in the exenatide group and −0.04 mmol/L in the insulin glargine 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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NCT01354990 · results posted 4 June 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 2,974 participants, all of whom were prescribed sitagliptin phosphate (brand name JANUVIA®), a medicine used in the management of type 2 diabetes. All 2,974 participants were recorded as having completed the study, with none listed as having dropped out. The trial was observational in nature, meaning it was set up to collect information about how the medicine was being used in real-world practice rather than to compare it against another treatment. The reported data shows it was measuring things like who was taking the medicine, what other medicines or health conditions they had alongside it, and whether any unwanted health events (adverse events) were recorded. The reported data shows that the average age of participants prescribed sitagliptin was 55 years. Of the 2,974 participants, 1,878 were recorded as taking other medicines at the same time as sitagliptin — these are called "concomitant therapies," meaning additional treatments taken alongside the study medicine. A further 752 participants were recorded as having other health conditions present at the same time as their diabetes, referred to as "concomitant conditions." Regarding unwanted health events, the reported data shows that 25 out of 2,974 participants experienced an adverse event — that is, a health problem that was recorded during the study period. No secondary outcome measures were 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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NCT00985712 · results posted 4 June 2012
According to the results reported on ClinicalTrials.gov, this trial compared two insulin injection pen devices — the HumaPen Luxura and the HumaPen Memoir — in people with diabetes. A total of 133 people were assigned to the HumaPen Luxura group and 130 to the HumaPen Memoir group at the start of the trial. The main thing being measured was the change in a blood test called HbA1c (a measure of average blood sugar levels over roughly three months) after 24 weeks of use. The reported data shows that, on average, HbA1c levels fell by 0.48 percentage points in the HumaPen Luxura group and by 0.43 percentage points in the HumaPen Memoir group over the 24-week period. When looking at how many participants reached specific HbA1c targets, 16.5% of the Luxura group and 11.0% of the Memoir group reached a level at or below 7.5%, while 5.5% of the Luxura group and 3.1% of the Memoir group reached at or below 7.0%. Participants were also asked how willing they would be to keep using their pen, rated on a scale of 1 (definitely unwilling) to 5 (definitely willing); both groups scored very similarly, at 4.06 for the Luxura and 4.05 for the Memoir. The reported data also shows that low blood sugar episodes (blood glucose at or below 3.9 mmol/L) occurred at an adjusted rate of about 2.68 per 30 days in the Luxura group and 2.46 per 30 days in the Memoir group, while high blood sugar episodes (above 18 mmol/L) were recorded at about 2.56 per 30 days for the Luxura group and 3.92 per 30 days for the Memoir 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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NCT00424762 · results posted 30 March 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 74 people in the rosiglitazone (a diabetes medication) group and 76 people in the placebo (inactive treatment) group. Of those, 54 people in each group completed the study. The trial was measuring how well people's hearts and bodies could use oxygen during exercise, the amount of fat stored inside the heart muscle, and how many people developed new or worsening fluid build-up in their legs or feet (known as peripheral oedema). The reported data shows that for the main measure — the peak amount of oxygen the body could take in during a treadmill test — the rosiglitazone group recorded an average of 26.1 millilitres of oxygen per kilogram of lean body mass per minute, compared with 27.6 in the placebo group. For the secondary measure of fat stored within the heart muscle (measured using a specialised type of MRI scan), the rosiglitazone group recorded 0.9% fat relative to water, compared with 0.85% in the placebo group. For the other secondary measure, the reported data shows that 54% of people in the rosiglitazone group developed new or worsening fluid build-up in their legs or feet, compared with 33% 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01068730 · results posted 29 March 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 28 participants in total, split into four groups of 7. It was a crossover study, meaning every participant received all four treatments at different times — two doses (500 mg and 1000 mg) of a medicine called metformin, each given as either the brand Diabex or the brand Glucophage. The trial was primarily measuring how the body absorbed and processed each version of the medicine, by tracking how much of the drug appeared in the bloodstream over time and what the highest level reached in the blood was. Almost all participants completed every stage; only two people left the study early across the four periods. The reported data shows that for the main measurements of drug absorption, the figures were quite similar between the two brands at each dose. For the 500 mg dose, the total amount of drug detected in the blood over time (a measure called "area under the curve") was reported as approximately 7,063 units for Diabex and 7,187 units for Glucophage. At the 1000 mg dose, these figures were approximately 11,578 for Diabex and 11,425 for Glucophage. For the peak level of drug measured in the blood, the 500 mg dose produced a reported high of about 1,014 units for Diabex and 1,020 for Glucophage, while the 1000 mg dose produced approximately 1,635 for Diabex and 1,593 for Glucophage. The reported data also shows that in the secondary measurements, no participants across any of the four treatment groups had clinically significant heart trace (ECG) abnormalities, abnormal physical examination findings, or vital sign changes recorded as medical events. Adverse events (unexpected medical occurrences during the study, which may or may not be related to the treatment) were reported in 6, 2, 5, and 6 participants across the four treatment groups respectively. No serious adverse events and no deaths were reported for any 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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NCT00730275 · results posted 30 January 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people in total, split across four groups: nine people received a 50 mg dose of sitagliptin, nine received 100 mg, eight received 200 mg, and nine received a placebo (a dummy treatment with no active ingredient). One person in the placebo group did not complete the trial; everyone else finished. The trial was primarily measuring how the body absorbed and processed different doses of sitagliptin — a medicine used in type 2 diabetes — and also tracked how many participants experienced any adverse events (unwanted health events) during the study. The reported data shows that when looking at how much of the drug was absorbed into the bloodstream over time (a measurement called "area under the curve"), the figures were 3,438 units for the 50 mg group, 5,869 for the 100 mg group, and 12,965 for the 200 mg group. The peak level of the drug in the blood was reported as 366 units (50 mg group), 666 units (100 mg group), and 1,876 units (200 mg group). The time it took to reach that peak level was around 3 hours for the two lower doses and 2.5 hours for the highest dose. The time for the drug's level in the blood to reduce by half was approximately 12 hours across all three dose groups. The trial also measured the effect on a specific enzyme in the blood called DPP-4 — a higher percentage figure means more of that enzyme's activity was reduced. Over a 24-hour average, the reported inhibition figures were roughly 74%, 81%, and 88% for the 50 mg, 100 mg, and 200 mg groups respectively, compared to about 7% in the placebo group. Regarding adverse events, 3 people in the 50 mg group, 1 in the 100 mg group, 1 in the 200 mg group, and 2 in the placebo group were reported to have experienced at least one adverse 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00935220 · results posted 10 November 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 41 people, all of whom received a 5 mg daily dose of linagliptin (a medicine used for type 2 diabetes). Thirty-nine participants completed the study, while two did not finish. The trial was primarily measuring how the drug moved through participants' bodies — specifically, how much of the medicine built up in the bloodstream over time and what the highest level in the blood reached once the body had settled into a regular pattern with the drug (known as "steady state"). The reported data shows that the main measurements — called AUC and C-max — reflect the drug's levels in the blood. At steady state, the average total drug exposure over a dosing period (AUC) was reported as 194 nmol·h/L, and the average peak blood level (the highest concentration reached) was 16.4 nmol/L. An earlier measurement taken in the first 24 hours after the very first dose showed a blood exposure level of 137 nmol·h/L. These figures simply describe how much of the medicine was present in the bloodstream at different points — they are not a measure of how well the drug treated any condition. The reported data also shows that 16 participants experienced at least one adverse event (an unwanted health occurrence noted during the study). Seven participants had adverse events considered possibly related to the study medicine. Five participants had abnormal results in tests such as blood tests, though none of these were reported as adverse events themselves. No abnormalities in heart tracing (ECG), blood pressure, pulse, or physical examination were recorded as adverse events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01068860 · results posted 5 September 2011
According to the results reported on ClinicalTrials.gov, this trial (NCT01068860) enrolled 246 participants across ten groups. Most participants had type 2 diabetes and were already taking one of several common diabetes medicines (metformin alone, metformin plus a sulfonylurea, metformin plus a sulfonylurea plus a thiazolidinedione, or insulin). A smaller group had "impaired glucose tolerance" — meaning their blood sugar was higher than normal but not yet at diabetes levels. Within each group, participants were randomly assigned to receive either canakinumab (a 150 mg injection) or a dummy (placebo) treatment for four weeks. The trial was primarily measuring how well the pancreas responded to a meal by releasing insulin — specifically, how much the rate of insulin release changed over the first two hours after a liquid meal test. The reported data shows that changes in the insulin secretion rate over the first two hours after the meal test (the primary measure) varied across the different treatment groups. For example, in the metformin-only group, the canakinumab group showed a change of −0.06 units compared to −0.23 units in the placebo group. In the insulin-plus-canakinumab group the change was +1.23 units, while the placebo-plus-insulin group showed −0.49 units. In the impaired glucose tolerance group, both the canakinumab (−1.50) and placebo (−1.93) groups showed a decline in this measure. The reported data also shows small changes in fasting blood sugar levels, fructosamine (a marker of average blood sugar over recent weeks), and fasting insulin levels across all groups, with the numbers varying in direction and size between groups. No single consistent pattern was reported across all subgroups for any of these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00755846 · results posted 29 August 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 265 people across six groups. Participants were randomly assigned to take either a placebo (a dummy pill with no active ingredient) or one of five different daily doses of a medicine called alogliptin (6.25 mg, 12.5 mg, 25 mg, 50 mg, or 100 mg), once a day. The main thing the trial was measuring was a blood marker called HbA1c — a percentage that reflects average blood sugar levels over roughly the past two to three months — specifically how much it changed after about 85 days. Not everyone who started the trial finished it: for example, 43 people started in the placebo group but only 18 completed it, and similar drop-out patterns occurred across the other groups. The reported data shows that, for the primary measure (HbA1c change at day 85), the placebo group's reading changed by −0.01 percentage points on average, meaning it stayed almost the same. The reported figures for the alogliptin groups ranged from −0.19 percentage points (lowest dose, 6.25 mg) to −0.56 percentage points (25 mg dose), with the other doses sitting between −0.44 and −0.54. For the same measure taken at the halfway point (day 43), the reported changes ranged from −0.12 (lowest dose) to −0.36 (25 mg), compared with a +0.02 change in the placebo group. The trial also measured fasting blood sugar levels and another blood marker called fructosamine at both time points. The reported data shows that fasting blood sugar at day 85 rose by an average of 8.5 mg/dL in the placebo group, while the alogliptin groups showed reported decreases ranging from −5.1 mg/dL (12.5 mg dose) to −27.0 mg/dL (25 mg dose). Fructosamine results at day 85 followed a broadly similar pattern, with the placebo group rising by 7.7 mg/dL and the alogliptin groups ranging from +0.2 mg/dL (lowest dose) to −16.4 mg/dL (25 mg 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00286455 · results posted 29 August 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 329 people across three groups: 65 received a placebo (a dummy pill with no active ingredient), 133 received a lower dose of alogliptin (12.5 mg once daily), and 131 received a higher dose of alogliptin (25 mg once daily). The trial was measuring changes in a blood marker called HbA1c — this is a measure of how much sugar has been attached to red blood cells over the past few months, expressed as a percentage. A lower HbA1c percentage is generally associated with lower blood sugar levels. The study ran for 26 weeks. Not everyone completed the trial: 40 of the 65 placebo participants, 105 of the 133 lower-dose participants, and 107 of the 131 higher-dose participants finished the full study period. The reported data shows that, for the main outcome measured at 26 weeks, the placebo group's HbA1c changed by an average of −0.02 percentage points from their starting level. The lower-dose alogliptin group showed an average change of −0.56 percentage points, and the higher-dose group showed an average change of −0.59 percentage points. The secondary outcomes tracked HbA1c at earlier time points (weeks 4, 8, 12, 16, and 20). The reported data shows that across all of these earlier time points, the placebo group's readings changed by between −0.11 and −0.13 percentage points, while both alogliptin groups showed larger reported changes ranging roughly from −0.37 to −0.66 percentage points depending on the time point and 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00870194 · results posted 17 June 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 255 adults with type 2 diabetes — 127 in one group and 128 in the other. Both groups received a medication called exenatide (an injectable diabetes medicine), but one group also took sitagliptin (a tablet) while the other took a placebo (a dummy tablet with no active ingredient). The trial ran for 20 weeks and was primarily measuring changes in a blood marker called HbA1c — a measure of average blood sugar levels over roughly three months. The reported data shows that, by week 20, both groups had lower HbA1c levels than when they started. The exenatide-plus-placebo group showed an average reduction of 0.38 percentage points, while the exenatide-plus-sitagliptin group showed an average reduction of 0.68 percentage points. For the secondary measures, the reported data shows that among patients who started with HbA1c above 7.0%, around 29.5% in the placebo group and 44.3% in the sitagliptin group reached a level at or below 7.0% by week 20. Regarding fasting blood sugar (a single blood glucose reading taken after overnight fasting), the placebo group's average changed by +0.06 mmol/L (a very slight rise), while the sitagliptin group's average fell by 0.55 mmol/L. For body weight, the reported data shows an average reduction of 2.58 kg in the placebo group and 2.20 kg in the sitagliptin group over the 20 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00804986 · results posted 15 June 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 247 adults across six groups. Five groups each received a different dose of an investigational drug called LY2428757 (at doses of 0.5 mg, 2.0 mg, 6.2 mg, 12.0 mg, or 17.6 mg), while a sixth group received a placebo (an inactive dummy treatment). The trial ran for 12 weeks and was primarily measuring changes in a blood marker called HbA1c — a measure of average blood sugar levels over roughly three months — expressed as a percentage. A number of other things were also tracked, including self-reported hunger and fullness, blood sugar readings taken at home at seven points throughout the day, blood sugar response after a sugary drink, average drug levels in the blood, and whether participants developed antibodies (immune proteins) against the drug. The reported data shows that, for the primary measure, HbA1c changed from the start of the trial to week 12 by the following amounts on average: −0.60 percentage points in the 0.5 mg group, −0.80 in the 2.0 mg group, −1.24 in the 6.2 mg group, −1.41 in the 12.0 mg group, −1.37 in the 17.6 mg group, and −0.13 in the placebo group. For self-monitored blood sugar readings at home, the reported average changes also varied across groups and dose levels, with the placebo group showing little change. For the hunger and fullness ratings (measured on a 0–100 scale), the reported changes at week 12 were modest across all groups, including the placebo group. The reported data also shows that small numbers of participants in each group — between one and three people — developed detectable antibodies to the drug at some point during the study. The reported data also shows average drug concentrations in the blood rose as the dose increased, from approximately 29.5 nanograms per millilitre in the lowest-dose group up to approximately 1,290 nanograms per millilitre in the highest-dose group, with zero detected in the placebo group, as expected. For the blood sugar response after a sugary drink, all groups including placebo showed some change, with the larger drug doses associated with larger reported reductions in 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00620282 · results posted 15 June 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 49 people in total across three groups: 16 received liraglutide at a dose of 1.8 mg (referred to here as "Lira 1.8"), 16 received a placebo (an inactive treatment), and 17 received a comparison diabetes medicine called glimepiride. By the end of the study, 16, 14, and 16 participants respectively had completed the trial. The trial was primarily measuring changes in forearm blood flow as a way of assessing how well the blood vessel lining (the endothelium) was functioning — specifically, how blood vessels responded to a substance called acetylcholine, which normally causes them to widen. The reported data shows that, for the main measurement (acetylcholine-related forearm blood flow), the Lira 1.8 group showed a change of +4.244 mL per 100 mL of forearm tissue per minute, the placebo group showed a change of −3.187, and the glimepiride group showed a change of +2.164. A similar secondary blood flow measurement (using a different substance, sodium nitroprusside) showed changes of +3.455, −1.044, and +2.746 for the three groups respectively. The reported data also shows changes in blood sugar markers: a measure of average blood sugar over time (HbA1c, expressed as a percentage) changed by −0.629, −0.094, and −0.552 percentage points for the three groups. Fasting blood sugar levels changed by −41.7, −6.1, and −32.0 mg/dL, and average after-meal blood sugar changed by −32.2, −20.3, and −36.0 mg/dL respectively. For body weight, the reported changes were −1.821 kg for the Lira 1.8 group, −0.293 kg for the placebo group, and +1.038 kg for the glimepiride 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 ↗ · Linked publication on PubMed ↗
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NCT00328172 · results posted 7 June 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 302 adults across five groups to compare different doses of a medicine called linagliptin (also known as BI 1356) against a placebo (a dummy treatment) and metformin (an existing diabetes medicine). The groups received either placebo (67 people), linagliptin at 0.5 mg (58 people), linagliptin at 2.5 mg (57 people), linagliptin at 5.0 mg (55 people), or metformin (65 people). The main thing the trial was measuring was the change in a blood marker called HbA1c — a measure of average blood sugar levels over roughly three months — after 12 weeks of treatment. The reported data shows that, at 12 weeks, the placebo group's HbA1c rose slightly on average by 0.18 percentage points from their starting level. The linagliptin groups saw average changes of +0.04 (0.5 mg dose), −0.24 (2.5 mg dose), and −0.28 (5.0 mg dose) percentage points respectively, while the metformin group saw an average decrease of −0.68 percentage points. For fasting blood sugar (a single blood glucose reading taken before eating), the reported changes from starting levels were: placebo +4.24 mg/dL, linagliptin 0.5 mg +6.69 mg/dL, linagliptin 2.5 mg −15.2 mg/dL, linagliptin 5.0 mg −9.09 mg/dL, and metformin −30.1 mg/dL. The trial also recorded how many participants reached an HbA1c at or below 7.0% by week 12 — a commonly referenced blood sugar target. The reported figures were: placebo 6.3%, linagliptin 0.5 mg 10.5%, linagliptin 2.5 mg 7.3%, linagliptin 5.0 mg 11.1%, and metformin 26.2%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00097786 · results posted 24 May 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 9,306 people across four groups. Participants received one of two active medicines — valsartan (a blood pressure medicine) and/or nateglinide (a medicine that lowers blood sugar after meals) — or matching dummy pills (placebos), in different combinations. The trial was measuring three things for each medicine: how many people went on to develop type 2 diabetes, and how many experienced serious heart and blood vessel events (tracked in two slightly different ways — a broader "extended" list and a narrower "core" list). The reported data shows the following for valsartan compared to those not taking it: 33.1% of people in the valsartan group progressed to diabetes, versus 36.8% in the non-valsartan group. For serious heart and blood vessel events using the broader measure, 14.5% of the valsartan group reached that point compared to 14.8% of the non-valsartan group. Using the narrower measure, both groups reported 8.1%. For nateglinide compared to those not taking it: 36.0% of the nateglinide group progressed to diabetes versus 33.9% of the non-nateglinide group. For the broader heart and blood vessel measure, 14.2% of the nateglinide group reached that point compared to 15.2% of the non-nateglinide group. For the narrower measure, 7.9% versus 8.3% 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00545584 · results posted 11 May 2011
According to the results reported on ClinicalTrials.gov, this trial involved 1,132 participants in total, split across three groups: 412 people received sitagliptin alongside standard medical care, 414 received sitagliptin alongside diet advice, and 306 received sitagliptin alongside both diet and physical activity advice. The trial was measuring blood sugar control in people with type 2 diabetes, using two main measures: HbA1c (a blood test that reflects average blood sugar levels over roughly three months, where a result above 6.5% was considered poorly controlled) and fasting plasma glucose (a measure of blood sugar after not eating, where a range of around 5.0–7.2 mmol/L is generally considered a target). Around 917 of the 1,132 participants completed the study. The reported data shows the following HbA1c percentage results across the three groups. At an earlier point in the study, the recorded figures were 7.37%, 7.50%, and 7.49% for the standard care, diet advice, and diet-plus-activity advice groups respectively. At a later measurement point, the figures were 7.33%, 7.42%, and 7.40% for the same three groups. For fasting plasma glucose, the reported data shows earlier readings of 8.87, 9.00, and 8.91 mmol/L across the three groups, and later readings of 8.21, 8.32, and 8.47 mmol/L respectively. The trial data does not include labels specifying exactly when each set of measurements was taken, so the precise timing of each reading 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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NCT00121641 · results posted 11 May 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 467 adults with type 2 diabetes across four groups: those taking saxagliptin at one of three doses (2.5 mg, 5 mg, or 10 mg daily) or a placebo (a dummy pill with no active ingredient). A separate open-label group of 66 people — meaning both the participants and researchers knew what was being given — also took part. The trial ran for up to 48 months in total, though the main measurements were taken at 24 weeks. The trial was primarily measuring changes in a blood marker called HbA1c, which reflects average blood sugar levels over roughly the previous two to three months. The reported data shows that at the start of the trial, HbA1c levels were similar across all groups, sitting between roughly 7.85% and 7.98%. After 24 weeks, the three saxagliptin groups each showed a reported decrease in HbA1c — by 0.43 percentage points in the 2.5 mg group, 0.46 in the 5 mg group, and 0.54 in the 10 mg group — while the placebo group's HbA1c went up by 0.19 percentage points. For fasting blood sugar (a blood glucose reading taken after not eating overnight), the reported changes at 24 weeks were reductions of roughly 14.5, 8.7, and 16.8 units (mg/dL) in the three saxagliptin groups respectively, compared with a rise of about 6 units in the placebo group. The proportion of participants whose HbA1c fell below 7.0% — a commonly used target level — was reported as 35.0%, 37.9%, and 41.1% across the three saxagliptin doses, compared with 23.9% in the placebo group. Blood sugar measured after a meal also showed reported reductions across all saxagliptin groups. In the separate open-label group, fasting blood sugar was reported to fall by around 33 units on average, and 14.1% of those participants reached an HbA1c below 7.0%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01055223 · results posted 18 April 2011
According to the results reported on ClinicalTrials.gov, this study involved 98,483 participants who all had type 2 diabetes and had been prescribed a class of diabetes medication called thiazolidinediones (TZDs). The study was designed to look at records of low-impact bone fractures — that is, breaks that happen from minor incidents like a small fall — among people taking TZDs, and to compare fracture counts between those taking TZDs alone and those also taking certain other medicines (spironolactone, amiloride, or other combinations). It was an observational study, meaning researchers reviewed existing health records rather than assigning people to different treatments. For each person who had a fracture (a "case"), up to four people without a fracture (called "controls") were selected from the same records for comparison. The reported data shows the following fracture counts after six months of TZD exposure: for overall low-impact fractures, there were 4,325 recorded among people taking TZDs alone (cases) compared to 17,296 controls in the same group; those also taking spironolactone had 105 cases and 292 controls; those taking amiloride had 12 cases and 31 controls. After 12 months, the reported numbers for low-impact fractures were 2,619 cases and 10,496 controls in the TZD-alone group; 64 cases and 181 controls in the TZD-plus-spironolactone group; and 8 cases and 20 controls in the TZD-plus-amiloride group. For the secondary measures — fractures specifically of the hand, foot, upper arm, and wrist, as well as hip fractures — similar case and control counts were reported across the same groups and time points, with hip fractures representing much smaller numbers (for example, 92 cases versus 387 controls in the TZD-alone group at six months). The reported data shows counts of fractures recorded within each group, but no further analysis figures (such as risk comparisons between groups) were included in the results submitted to ClinicalTrials.gov, so those 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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NCT00899470 · results posted 25 March 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 healthy participants split into four groups of six. Each group took the same four treatments but in a different order, with "washout" rest periods in between — meaning time was allowed for the previous treatment to leave the body before the next one began. The trial was comparing two ways of taking the diabetes-related medicines saxagliptin and metformin: either as two separate tablets taken together, or as a single combined (fixed-dose combination, or FDC) tablet. Both were tested on an empty stomach (fasted) and after a meal (fed). The measurements focused on how much of each medicine entered the bloodstream and how quickly. The reported data shows the following for saxagliptin: the peak level of the medicine in the blood (called Cmax, or the highest concentration recorded) was 8.57 ng/mL for the separate tablets fasted, 8.61 ng/mL for the combined tablet fasted, 11.36 ng/mL for the separate tablets fed, and 11.51 ng/mL for the combined tablet fed. The total amount of saxagliptin absorbed over time was also similar across the four conditions — around 48–56 ng·h/mL depending on whether fed or fasted, and whether separate or combined tablet. The time it took for the medicine to reach its peak level ranged from roughly 1.2 to 1.8 hours, and the time for half the medicine to leave the body ranged from about 5.5 to 5.9 hours across conditions. For metformin, the reported peak blood levels were around 993–1,043 ng/mL across all four conditions, and the total absorption figures ranged from approximately 7,177 to 7,575 ng·h/mL — again appearing broadly similar across 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00962065 · results posted 3 March 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people in total — 12 in a low-dose group, 12 in a high-dose group, and 12 in a placebo group (a placebo is a dummy treatment with no active ingredient, used for comparison). All 36 participants completed the study. The trial was measuring how different doses of the study treatment compared to placebo across a range of blood sugar, blood pressure, and blood fat markers over approximately 28 days. The reported data shows that for the main thing being measured — the change in the amount of glucose (sugar) passed out in urine over 24 hours — the low-dose group showed an average increase of about 35.7 grams and the high-dose group an increase of about 47.1 grams from their starting point, while the placebo group showed a very small decrease of about 1 gram. For blood sugar levels measured after an overnight fast, the low-dose group showed an average drop of 52.3 mg/dL and the high-dose group a drop of 67.8 mg/dL, compared to a drop of 12.3 mg/dL in the placebo group. Two other blood sugar markers — HbA1c (a measure of average blood sugar over several weeks) and fructosamine (a shorter-term blood sugar marker) — also showed larger reductions in both treatment groups compared to placebo. Blood fat levels (triglycerides) dropped by around 63–67 mg/dL in both treatment groups versus about 20 mg/dL in the placebo group. Changes in blood pressure (mean arterial pressure) were also reported across multiple time points, with reductions seen in all 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00366301 · results posted 25 November 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 500 people across four groups. Each group received a different treatment combination: a placebo (dummy) pill alone, metformin (a diabetes-related medicine) pill alone, insulin glargine (an injectable insulin) plus a placebo pill, or insulin glargine plus metformin. The trial was measuring changes in a substance in the blood called C-reactive protein, or CRP — a marker that the body produces, which researchers tracked as a percentage change over the course of the study. The numbers who completed the trial were 116, 120, 122, and 116 across the four groups respectively. The reported data shows that CRP levels changed in all four groups by the end of the study. In the placebo pill group, CRP fell by around 19%; in the metformin pill group, it fell by around 16.1%; in the insulin glargine plus placebo pill group, it fell by around 2.9%; and in the insulin glargine plus metformin group, it fell by around 20.1%. It is worth noting that no secondary outcome measure data was included in the structured results provided. The reported data does not include information on any other outcomes, side effects, or safety findings in this structured submission, 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00548808 · results posted 15 September 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 426 people in total — 214 in the Insulin Lispro LM group and 212 in the Insulin Glargine group. The trial ran for 48 weeks and was primarily measuring changes in a blood test called HbA1c (haemoglobin A1c), which reflects average blood sugar levels over roughly the past two to three months. A lower HbA1c number generally indicates lower average blood sugar. The trial compared two different insulin treatments to see how each group's HbA1c levels changed over time. The reported data shows that, after 48 weeks, both groups had lower HbA1c readings than when they started. The Insulin Lispro LM group's average HbA1c fell by 1.91 percentage points, while the Insulin Glargine group's fell by 1.87 percentage points. For secondary outcomes, the reported data shows that around 21% of the Lispro LM group and 19% of the Glargine group reached an HbA1c below 6.5% by week 48, while approximately 40% in each group reached below 7%. Self-monitored blood sugar readings at various points in the day were broadly similar between the two groups throughout the study. Daily insulin doses also tracked closely between groups, reaching around 55 units per day by week 48 in both cases. The reported data also shows changes in a separate marker called GlycoMark (which reflects short-term blood sugar fluctuations after meals) — both groups showed increases in this marker over time, with figures at 48 weeks of 5.24 for the Lispro LM group and 4.89 for the Glargine 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 ↗ · Linked publication on PubMed ↗
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NCT00631007 · results posted 13 September 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 367 people across six groups to compare different doses of an investigational medicine called INT131 Besylate against an existing diabetes medicine (pioglitazone) and a placebo (a dummy treatment with no active ingredient). Each group had roughly 60–63 people at the start. The trial ran for 24 weeks and was primarily measuring changes in a blood marker called HbA1c — a percentage figure that reflects average blood sugar levels over the previous few months. A secondary measure was fasting plasma glucose (a blood sugar reading taken after an overnight fast, measured in mg/dL). The reported data shows that after 24 weeks, HbA1c changed from the starting level by the following amounts: the placebo group saw a change of −0.1%, while the four INT131 Besylate dose groups saw changes of −0.3% (0.5 mg), −0.6% (1 mg), −0.9% (2 mg), and −1.0% (3 mg). The pioglitazone group saw a change of −0.9%. For fasting plasma glucose, the reported changes were: placebo +4.6 mg/dL, INT131 Besylate 0.5 mg −0.3 mg/dL, 1 mg −14.6 mg/dL, 2 mg −28.9 mg/dL, 3 mg −26.9 mg/dL, and pioglitazone −33.2 mg/dL. A negative number in both measures means the level went down from where it started. Not everyone who started the trial finished it — between 9 and 15 people dropped out from each group, though the data as submitted does not explain the reasons for each individual's withdrawal. No other outcome figures beyond these two measures were included in the structured results data submitted to the registry. 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 ↗
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NCT00139659 · results posted 12 May 2010
According to the results reported on ClinicalTrials.gov, this trial compared two ways of delivering insulin to people with diabetes — by inhalation versus by injection under the skin (subcutaneous). A total of 146 people were assigned to the inhaled insulin group and 141 to the injected insulin group. The main thing the trial was measuring was how lung function — specifically a breathing test called FEV1 (how much air a person can forcefully breathe out in one second) — changed over time in each group. The reported data shows that, on average, both groups experienced a small decline in FEV1 over the course of the study. In the inhaled insulin group, lung function declined at a rate of about 0.070 litres per year, compared with about 0.035 litres per year in the injected insulin group. The secondary measurements, which looked at lung function from several different angles and at multiple time points, also consistently showed small reductions from starting levels in both groups, with the inhaled insulin group generally showing slightly larger reductions. For example, one measure of how well the lungs transfer gases (called DLco) fell by around 1.17 units in the inhaled insulin group versus around 0.67 units in the injected insulin group by the final measurement point. It is worth noting that 40 people in the inhaled insulin group did not complete the study, compared with 18 in the injected insulin group; the reasons for this were not detailed 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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NCT00944450 · results posted 27 April 2010
According to the results reported on ClinicalTrials.gov, this trial involved 12 people in total, split into two groups of six. It was a crossover study, meaning everyone took both versions of the same medicine — sitagliptin (also called MK0431) — but in a different order. One group took the "anhydrous" form first, then the "monohydrate" form; the other group did it the other way around. The trial was comparing these two forms of the drug to see how similarly they were absorbed into the bloodstream after a single dose. The reported data shows two main things were measured. The first was how much of the drug was absorbed overall over time — a figure called the "area under the curve," which is essentially a way of tracking the total amount of drug in the blood from the moment it's taken until it's fully cleared. For the anhydrous form, this figure was 8.38 μmol\*hr/L, and for the monohydrate form it was 8.78 μmol\*hr/L. The second measurement was the highest level the drug reached in the blood at any one point (called the "peak concentration"). The reported data shows this was 799 μmol/L for the anhydrous form and 856 μmol/L for the monohydrate form. All 12 participants completed both periods of the study with no dropouts recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00614120 · results posted 12 March 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 929 adults across four groups, all of whom were also taking metformin (a common diabetes tablet). Three groups received different doses of liraglutide (0.6 mg, 1.2 mg, or 1.8 mg), while a fourth group received glimepiride (another diabetes medicine) as a comparison. The trial ran for 16 weeks and the main thing being measured was a blood marker called HbA1c — a way of tracking average blood sugar levels over the previous few months. Between 175 and 215 participants in each group completed the full 16 weeks of the trial. The reported data shows that, on average, HbA1c levels fell in all four groups over the 16 weeks. The liraglutide 0.6 mg group saw a drop of 1.0 percentage point, the 1.2 mg group dropped 1.3 percentage points, the 1.8 mg group dropped 1.4 percentage points, and the glimepiride group also dropped 1.3 percentage points. For body weight (a secondary measure), the three liraglutide groups reported average reductions of 1.8 kg, 2.3 kg, and 2.4 kg respectively, while the glimepiride group reported an average change of +0.1 kg (essentially no change). Self-measured fasting blood sugar also fell across all groups, ranging from approximately 1.8 to 2.3 units (mg/dL). A measure of how well insulin-producing cells were functioning (called HOMA-B) showed increases across all groups, ranging from about 15 to 22 percentage points. Changes in blood fats (cholesterol and related measures) were small across all groups, and the reported data shows only minor differences between 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00395746 · results posted 12 March 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 264 people in total, split evenly into three groups of 88. One group took a 0.6 mg dose of a study medication alongside an existing diabetes tablet called a sulphonylurea (referred to here as SU), a second group took a 0.9 mg dose combined with the same SU tablet, and a third group took the SU tablet on its own. The trial ran for 52 weeks and was mainly measuring a blood marker called HbA1c — a standard test that reflects average blood sugar levels over roughly three months, expressed as a percentage. By the end of the study, 78, 84, and 66 participants in each group respectively had completed the trial. The reported data shows that after 24 weeks, the average HbA1c reading was 7.02% in the 0.6 mg combination group, 6.75% in the 0.9 mg combination group, and 8.02% in the SU-only group. At 52 weeks, the reported figures were 7.42%, 7.06%, and 8.39% respectively. For fasting blood sugar (measured after not eating overnight, in units called mg/dL), the reported data shows readings of 132.2, 126.2, and 158.8 at 24 weeks, rising to 140.3, 134.5, and 164.6 at 52 weeks across the three groups in the same order. The trial also measured blood sugar levels in the three hours after a meal; at 24 weeks those figures were reported as 614.58, 575.50, and 725.72 (in mg/dL·h, a combined measure of how high and how long blood sugar stayed raised), and at 52 weeks as 648.87, 589.98, and 717.55. 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 ↗
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NCT00318461 · results posted 12 March 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,091 participants across five groups. Four groups took a medication called liraglutide (at three different doses: 0.6 mg, 1.2 mg, or 1.8 mg) combined with metformin, or metformin combined with a different drug called glimepiride. A fifth group took metformin on its own. The trial was primarily measuring changes in a blood sugar marker called HbA1c — a percentage that reflects average blood sugar levels over roughly three months. There was an initial blinded phase of six months, followed by an open-label extension (where participants knew what they were taking) lasting a further 18 months. The reported data shows that after 26 weeks, HbA1c changed by −0.69 percentage points in the liraglutide 0.6 mg + metformin group, −0.97 in the 1.2 mg group, and −1.00 in the 1.8 mg group, compared with +0.09 (a small rise) in the metformin-only group and −0.98 in the metformin + glimepiride group. For body weight, the reported data shows changes at 26 weeks of −1.78 kg, −2.58 kg, and −2.79 kg for the three liraglutide groups respectively, −1.51 kg for metformin alone, and +0.95 kg (a small gain) for the metformin + glimepiride group. At two years (104 weeks), body weight changes were reported as −2.07 kg, −3.03 kg, −2.91 kg, −1.80 kg, and +0.70 kg across the same five groups. Fasting blood sugar levels and after-meal blood sugar rises were also measured and showed varying changes across the groups at both time points, as detailed in the full 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 ↗
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NCT00377858 · results posted 3 December 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 242 people in each of two groups — one group took an insulin called Insulin Lispro Mid Mixture, and the other took an insulin called Insulin Glargine. The trial ran for 36 weeks and was primarily measuring a blood marker called HbA1c (haemoglobin A1c), which gives an indication of average blood sugar levels over roughly the past two to three months. Around 211–215 people in each group completed the full trial period. The reported data shows that at the 36-week mark, the average HbA1c reading was 7.66% in the Insulin Lispro Mid Mixture group and 7.49% in the Insulin Glargine group. Earlier check-ins at 12 and 24 weeks showed similar patterns, with both groups recording lower HbA1c figures as the trial progressed. When looking at the proportion of participants who reached certain HbA1c targets at the end of the trial, the reported data shows that roughly 21% of the Lispro Mid Mixture group and 25% of the Glargine group had an HbA1c at or below 6.5%. Daily self-monitored blood sugar readings and measures of how much blood sugar varied from day to day were also recorded, and the reported numbers were broadly similar between the two groups across all time points. The reported data also shows the number of participants who experienced at least one low blood sugar episode (called hypoglycaemia) during the trial. Overall, 178 people in the Lispro Mid Mixture group and 179 in the Glargine group reported at least one such episode at any point during the study; for episodes occurring overnight specifically, 87 people in the Lispro Mid Mixture group and 106 in the Glargine group reported at least one. These are counts of participants who reported episodes, not a measure of how the treatments compare — the trial's design and statistical analysis would need to be reviewed by a qualified health professional to interpret what these numbers mean in 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00379769 · results posted 13 November 2009
According to the results reported on ClinicalTrials.gov, this trial involved people with type 2 diabetes who were already taking one of two common diabetes medicines — metformin or a sulphonylurea — and were then randomly assigned to add a second medicine to their treatment. The four treatment groups compared adding rosiglitazone (RSG) or a sulphonylurea (SU) to metformin, and adding rosiglitazone or metformin to a sulphonylurea. Across the four groups, roughly 1,100 people started in each, giving a total of about 4,447 participants in the main study phase. A later observational follow-up phase tracked approximately 2,530 of those participants (grouped into a combined RSG group and a combined comparison group) without any change to their treatment. The reported data shows that the main thing the trial was measuring was how many people in each broad treatment group experienced either a hospitalisation for a heart or blood vessel problem, or a death from a cardiovascular (heart/blood vessel) cause. According to the results reported on ClinicalTrials.gov, 321 participants in the combined RSG group and 323 participants in the combined comparison group (those who had added metformin or sulphonylurea) had one of these events. For secondary measures — which looked at a wider range of events including heart attacks, strokes, heart failure, and deaths from any cause — the reported numbers were broadly similar between the two broad groups. For example, 154 participants in the combined RSG group and 165 in the comparison group had a heart attack or cardiovascular death; 171 versus 184 died from any cause. One notable secondary measure was blood sugar control: far fewer participants in the rosiglitazone-added groups (281 and 365, depending on the background medicine) had their blood sugar levels rise to the point of being classified as a treatment failure, compared with the comparison groups (451 and 424 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00316082 · results posted 25 September 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 365 adults across five groups to study different doses and timing of a diabetes medicine called saxagliptin compared to a placebo (a dummy pill with no active ingredient). The groups tested saxagliptin at 2.5 mg taken in the morning, 5 mg in the morning, a combination dose of 2.5 mg that could increase to 5 mg in the morning, and 5 mg taken in the evening. The main thing the trial was measuring was a blood marker called HbA1c (haemoglobin A1c) — a way of reflecting average blood sugar levels over roughly three months — and how much it changed after 24 weeks. Of the 365 people who started, between 41 and 52 people in each group fully completed the study. The reported data shows that at the start of the trial, average HbA1c levels across the groups ranged from about 7.79% to 8.04%. After 24 weeks, the reported average change in HbA1c was a reduction of around 0.63–0.71 percentage points in the three morning saxagliptin groups, and a reduction of around 0.61 percentage points in the evening 5 mg group, compared with a reduction of 0.26 percentage points in the placebo group. For the secondary outcomes, the reported data shows the proportion of participants whose HbA1c fell below 7% at week 24 ranged from about 36% to 45% across the saxagliptin groups, compared with about 35% in the placebo group. Changes in fasting blood sugar levels and post-meal blood sugar responses were also measured; some of the individual figures for these measures were not fully reported in the submitted data for all 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00135330 · results posted 28 August 2009
According to the results reported on ClinicalTrials.gov, this trial involved 137 people with type 2 diabetes, split across three groups: 45 received exenatide (a diabetes injection), 47 received exenatide combined with rosiglitazone (a diabetes tablet), and 45 received rosiglitazone alone. The trial ran for 20 weeks and was mainly measuring changes in how well the insulin-producing cells in the pancreas (called beta-cells) were working, using a specialised test called a hyperglycaemic clamp. It also looked at blood sugar and insulin levels during a meal test, and how well the body responded to insulin. By the end of the study, 33, 34, and 34 participants completed each group respectively, meaning roughly 11–13 people in each group did not finish. The reported data shows that the primary measurement — a score reflecting beta-cell output during the clamp test — started at around 643, 686, and 786 units for the exenatide, combination, and rosiglitazone groups respectively. After 20 weeks, the reported changes from those starting points were approximately +747 units for exenatide, +195 units for the combination group, and −100 units for the rosiglitazone group (meaning the rosiglitazone group's score was slightly lower than where it started). For the meal test, blood sugar levels were reported to have changed by approximately −560, −635, and −426 units across the three groups respectively. Other secondary measurements covering insulin levels during the meal test and insulin sensitivity scores were also reported, with the reported data showing varying changes across the three groups over the 20 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00886340 · results posted 22 April 2009
According to the results reported on ClinicalTrials.gov, this trial involved 58 people in total, split into two groups: 27 people in an "Enhanced Standard Care" group and 31 people in a "Lifestyle Counselling" group. The trial was measuring whether participants could reach a weight loss goal of 5% of their body weight. All 27 people in the Enhanced Standard Care group completed the study, while 24 out of 31 people in the Lifestyle Counselling group completed it (7 did not finish). The reported data shows that in the Enhanced Standard Care group, 3 out of 27 participants reached the 5% weight loss goal. In the Lifestyle Counselling group, 6 out of 24 participants who completed the study reached that same goal. The trial also intended to measure diet and exercise behaviour, blood fat levels (lipids), and quality of life as secondary outcomes, however no numbers for these measures were reported 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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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.