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 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.
View full results on ClinicalTrials.gov ↗
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 within the last 24 months
- Your HbA1c (a blood test that measures average blood sugar levels over time) was between 6.5% and 7.5% at the first visit
- You have not previously taken any medication for diabetes
- Your body weight falls within a certain healthy range — specifically, your BMI (a measure based on height and weight) is between 22 and 40 at the first visit
Who may not be able to join:
- You are currently pregnant or breastfeeding
- Your fasting blood sugar level is very high (270 mg/dL or above, measured after not eating)
- You have previously taken part in, or are currently part of, any clinical trial involving the drug vildagliptin
- You have previously had an allergic reaction to a group of diabetes medications known as DPP-4 inhibitors (confirm with trial site)
- You have another ongoing health condition that could affect the results or safety data of the study (confirm with trial site)
- You have donated blood, experienced significant blood loss, or received a blood transfusion recently — specifically, blood donation or loss within the past 2 weeks, a transfusion within the past 12 weeks, or if you plan to have regular transfusions during the study
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: Novartis Pharmaceuticals, Novartis Pharmaceuticals
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
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to Initial Treatment Failure
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.