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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2016

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).
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top