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A Double-Blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Followed by an Extension Study to 52 Weeks to Evaluate Long-Term Safety.

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A Double-Blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Followed by an Extension Study to 52 Weeks to Evaluate Long-Term Safety.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2017

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At a glance

  • Drugs Linagliptin (Primary) ; Voglibose
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 17 Aug 2017 Results (n=2065) of pooled analysis of this and other similar 15 studies assessing efficacy and safety based upon age, obesity, and renal function, published in the Advances in Therapy.
    • 17 Sep 2013 A meta-analysis will be presented at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD), according to a Boehringer Ingelheim and Eli Lilly media release.
    • 01 Apr 2012 Primary endpoint of change in HbA1c at week 12 and 26 has been met, according to results published in Diabetes, Obesity and Metabolism.

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