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A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)
The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | PHASE3 |
| Status | TERMINATED |
| Enrolment | 299 |
| Start date | Wed Oct 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Nov 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Type 2 Diabetes Mellitus
Interventions
- Sitagliptin/Simvastatin FDC
- Sitagliptin
- Simvastatin
- Placebo to sitagliptin
- Placebo to simvastatin
- Placebo to Sitagliptin/Simvastatin FDC
- Metformin
- Glimepiride