A Randomised Double-Blind, Active-Controlled Parallel Group Efficacy and Safety Study of BI 1356 (5.0 mg, Administered Orally Once Daily) Compared to Glimepiride (1 to 4 mg Once Daily ) Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy.

Trial Profile

A Randomised Double-Blind, Active-Controlled Parallel Group Efficacy and Safety Study of BI 1356 (5.0 mg, Administered Orally Once Daily) Compared to Glimepiride (1 to 4 mg Once Daily ) Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy.

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2015

At a glance

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

    • 25 Jun 2013 Results from an exploratory tolerability analysis presented at the 73rd Annual Scientific Sessions of the American Diabetes Association.
    • 18 Oct 2012 Planned number of patients changed from 1560 to 2400 as reported by EudraCT record.
    • 27 Jun 2012 Results published in the Lancet (online).
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