A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Placebo and Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2 Diabetes

NCT01549964 Phase 3 TERMINATED Results posted

The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50 mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus metformin on lowering blood sugar.

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	TERMINATED
Enrolment	916
Start date	2012-04
Completion	2014-03

Conditions

• Glycemic Control

Interventions

• Fasiglifam (TAK-875)
• Sitagliptin
• Placebo

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 relative to Baseline. A Mixed Model Repeated Measures (MMRM) model was used for analysis with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure.

Countries

United States, Australia, Bulgaria, Croatia, Czechia, Hungary, Italy, Malaysia, Slovakia, South Korea, Thailand