Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes

Summary

The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific adults with type 2 diabetes mellitus (T2DM).

Timeline

Start

2012-10

Primary completion

2014-02

Completion

2014-03

Outcome

Met primary endpoint

Stopped: “Due to potential concerns about liver safety (See Detailed Description)”

registry Placebo vs Fasiglifam 50 mg; p <0.001; Least squares mean difference -1.03 (95% CI -1.27 to -0.78) NCT01647542 ↗

Publications

• Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB. Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program. Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fasiglifam	Small molecule	25 mg	Oral
Subject	Fasiglifam	Small molecule	50 mg	Oral

Indications