Trial 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
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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 25488587) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 Type 2 Diabetes Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You have been diagnosed with type 2 diabetes for at least 6 months before the screening visit.
- You are currently taking at least 1000 mg of metformin per day, and your dose has not changed in the last 3 months.
- You are currently taking at least 100 mg of sitagliptin per day, and your dose has not changed in the last 3 months.
- You have never previously been treated with insulin (short-term insulin use during illness for up to 14 days, or insulin used during pregnancy, is acceptable).
- Your blood sugar control (HbA1c) is between 7.0% and 10.0%, showing that your diabetes is not fully controlled on your current medications.
- Your Body Mass Index (BMI) is 40 or below.
- You are able and willing to eat at least two meals (breakfast and dinner) every day during the trial.
Who may not be able to join:
- You have taken certain diabetes medications called thiazolidinediones (TZDs) or GLP-1 receptor agonists (such as certain injectable diabetes drugs) in the last 3 months.
- You have had a serious heart condition in the last 6 months, such as severe heart failure, unstable chest pain (angina), or a heart attack.
- You have severely high blood pressure (systolic 180 mmHg or above, or diastolic 100 mmHg or above) measured at the screening visit.
- Your doctor expects that the dose of any medication that could affect your blood sugar levels may need to change during the trial (for example, steroid tablets).
- You have a significant medical condition (other than type 2 diabetes) that the trial doctor believes could affect the trial results or put you at additional risk (confirm with trial site).
- Your liver is not functioning well, based on specific blood test results being more than 2.5 times higher than the normal range.
- Your kidneys are not functioning well enough, based on specific blood test results for kidney function falling below the required levels for this trial (confirm with trial site for exact values).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.