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A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Glimepiride When Used in Combination With Metformin in Subjects With Type 2 Diabetes
The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM). The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM).
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 2454 |
| Start date | 2012-01 |
| Completion | 2014-04 |
Conditions
- Diabetes Mellitus, Type 2
Interventions
- TAK-875
- TAK-875
- Glimepiride
Primary outcomes
- Change From Baseline in HbA1c at Weeks 78 and 104 — Baseline and Weeks 78 and 104
The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) to be collected at Weeks 78 and 104 relative to baseline.
Countries
United States, Argentina, Australia, Bulgaria, Canada, Colombia, Czechia, Estonia, Hong Kong, Israel, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Philippines, Poland, Romania, Russia, South Africa, Taiwan, Ukraine, United Kingdom