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An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies.

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Trial Profile

An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Dec 2023

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At a glance

  • Drugs Trelagliptin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Takeda

Most Recent Events

  • 26 Mar 2015 According to Takeda Pharmaceuticals media release, based on the results of this and other phase III trials ( see profile 226639 and 219690), Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application of Zafatek (trelagliptin succinate).
  • 22 Sep 2011 Planned end date changed to 1 Jul 2013 as reported by ClinicalTrials.gov.
  • 09 Sep 2011 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health; NCT01431807).

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