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)

NCT01678820

Phase 3 Terminated 299 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
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