NCT01549964

Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 916 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

TAK-875 is being developed at Takeda Development Center, Inc. as an adjunct to diet and exercise to improve glycemic control in participants with Type 2 Diabetes Mellitus (T2DM) whose blood glucose level is inadequately controlled with metformin. This study will evaluate the efficacy of TAK-875 (25 mg and 50 mg) plus metformin compared to placebo plus metformin and sitagliptin plus metformin on glycemic control as measured by change from baseline in glycosylated hemoglobin (HbA1c) over a 24-week Treatment Period. Participants completing the 24-week Treatment Period may enter an optional 80-week extension period for a total of 104 weeks of treatment. Due to concerns about potential liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks. For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

Conditions

• Glycemic Control

Interventions

Type	Name	Description
DRUG	Fasiglifam (TAK-875)	Fasiglifam (TAK-875) tablets
DRUG	Sitagliptin	Sitagliptin tablets
DRUG	Placebo	Placebo-matching tablets

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-03-09
• Last updated: 2016-06-02
• Results posted: 2016-06-02

Locations

160 sites across 11 countries: United States, Australia, Bulgaria, Croatia, Czechia, Hungary, Italy, Malaysia, Slovakia, South Korea, Thailand