Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes

Phase 3 Completed 421 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).

Timeline

Start: 2011-11
Primary completion: 2013-07
Completion: 2013-07

Outcome

Met primary endpoint

registry Placebo vs Fasiglifam 25 mg; p <0.001; LS Mean Difference -0.48 (95% CI -0.72 to -0.24) NCT01456195 ↗

registry Placebo vs Fasiglifam 50 mg; p <0.001; LS Mean Difference -0.76 (95% CI -1.00 to -0.52) NCT01456195 ↗

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