A phase III randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free combination of BI 1356 2.5 mg + metformin 500 mg, or of BI 1356 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg, twice daily), and BI 1356 (5.0 mg, once daily) over 24 weeks in drug naïve or previously treated (4 weeks wash-out and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control

Trial Profile

A phase III randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free combination of BI 1356 2.5 mg + metformin 500 mg, or of BI 1356 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg, twice daily), and BI 1356 (5.0 mg, once daily) over 24 weeks in drug naïve or previously treated (4 weeks wash-out and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

At a glance

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

    • 31 May 2016 According to Boehringer Ingelheim media release, the U.S. Food and Drug Administration (FDA) has approved Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets for the treatment of type 2 diabetes (T2D) in adults.
    • 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.
    • 04 Jul 2012 Planned number of patients changed from 740 to 1700 as reported by European Clinical Trials Database.(Parent trial: EudraCT2008-001640-40).
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