Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes

Phase 3 Terminated 96 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of fasiglifam (TAK-875) plus metformin compared with sitagliptin plus metformin on glycemic control over a 24-week Treatment Period.

Timeline

Start: 2013-06
Primary completion: 2014-03
Completion: 2014-03

Outcome

Outcome not reported

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

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	50 mg	Oral
Comparator	Sitagliptin	Small molecule	100 mg	Oral
Background	Metformin	Small molecule	1500 mg	Oral