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

Phase 3 Terminated 916 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2012-04
Primary completion: 2014-03
Completion: 2014-03

Outcome

Met primary endpoint

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

registry Placebo vs Fasiglifam 25 mg; p <0.001; LS Mean Difference -0.55 (95% CI -0.77 to -0.34) NCT01549964 ↗

registry Placebo vs Fasiglifam 50 mg; p <0.001; LS Mean Difference -0.82 (95% CI -1.03 to -0.60) NCT01549964 ↗

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
Comparator	Sitagliptin	Small molecule	100 mg	Oral