A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral Fasiglifam 25 mg and 50 mg Compared to Placebo When Used in Combination With Sitagliptin in Subjects With Type 2 Diabetes
Phase of Trial: Phase III
Latest Information Update: 28 Feb 2018
At a glance
- Drugs Fasiglifam (Primary) ; Sitagliptin
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors Takeda
- 28 Feb 2018 Results of an integrated pooled analysis (n=9139) assessing the hepatic safety of fasiglifam from the data of 15 double-blind studies from both global and Japanese development programs (six phase II and nine phase III) including this study, published in the Drug Safety Journal.
- 10 Jun 2017 Biomarkers information updated
- 27 Dec 2013 Status changed from recruiting to discontinued, as reported by a Takeda media release.