A Randomised, db, Placebo-Controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-Blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication).

Trial Profile

A Randomised, db, Placebo-Controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-Blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication).

Completed
Phase of Trial: Phase III

Latest Information Update: 11 Dec 2013

At a glance

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

    • 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.
    • 04 Dec 2011 34-week extension study results presented at the 21st World Diabetes Congress.
    • 24 Sep 2010 Primary endpoint 'Proportion of glycosylated haemoglobin' has been met, according to interim results reported at the 46th Annual Meeting of the European Association for the Study of Diabetes.
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