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A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 50 mg Compared With Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy of fasiglifam (TAK-875) plus metformin compared with sitagliptin plus metformin on glycemic control over a 24-week Treatment Period.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 96 |
| Start date | 2013-06 |
| Completion | 2014-03 |
Conditions
- Diabetes Mellitus, Type 2
Interventions
- Fasiglifam (TAK-875)
- Fasiglifam (TAK-875) Placebo
- Sitagliptin
- Sitagliptin Placebo
- Metformin
Primary outcomes
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) — Baseline and Week 24
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 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.
Countries
United States, Argentina, Canada, Croatia, Hungary, Malaysia, Peru, Philippines, Poland, Russia, South Africa, Thailand, Ukraine