A Randomised, Double-Blind, Placebo-Controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy.

Trial Profile

A Randomised, Double-Blind, Placebo-Controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2016

At a glance

  • Drugs Linagliptin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 17 Sep 2013 Data 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.
    • 05 Dec 2012 Last checked against European Clinical Trials Database record.
    • 05 Dec 2012 Planned number of patients changed from 702 to 1200 as reported by European Clinical Trials Database.
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