drugset / Trial / NCT01678820
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)
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2012-10-10
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Simvastatin | Small molecule | 40 mg | Oral |
| Comparator | Sitagliptin | Small molecule | 100 mg | Oral |
| Subject | Sitagliptin/Simvastatin FDC | Unknown | 40 mg | Oral |
| Subject | Sitagliptin/Simvastatin FDC | Unknown | 100 mg | Oral |
| Background | Glimepiride | Small molecule | 6 mg | — |
| Background | Metformin | Small molecule | 1500 mg | — |