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A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 50 mg Compared With Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2 Diabetes

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A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 50 mg Compared With Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2 Diabetes

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2018

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At a glance

  • Drugs Fasiglifam (Primary) ; Metformin; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda; Takeda Global Research and Development Center

    • Most Recent Events

    • 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.
    • 27 Dec 2013 Status changed from recruiting to discontinued, as reported by a Takeda media release.
    • 10 Aug 2013 New source identified and integrated (European Clinical Trials Database, EudraCT2013-000542-19).

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