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A Phase 2, Randomized, Placebo-Controlled, Factorial, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of 25 mg and 50 mg of TAK-875 in Combination With Sitagliptin 100 mg in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), in combination with sitagliptin QD in participants with type 2 diabetes mellitus (T2DM).
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 368 |
| Start date | 2011-08 |
| Completion | 2012-08 |
Conditions
- Diabetes Mellitus, Type 2
Interventions
- Placebo
- TAK-875
- TAK-875
- Sitagliptin
- TAK-875 and Sitagliptin
- TAK-875 and Sitagliptin
Primary outcomes
- Change from Baseline in Glycosylated Hemoglobin (HbA1c) — Baseline and Week 12.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 relative to baseline.
Countries
United States