A randomised, double-blind, placebo-controlled, five parallel group study investigating the efficacy and safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg administered orally once daily) over 12 weeks in drug naive and treated patients with type 2 diabetes with insufficient glycemic control.

Trial Profile

A randomised, double-blind, placebo-controlled, five parallel group study investigating the efficacy and safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg administered orally once daily) over 12 weeks in drug naive and treated patients with type 2 diabetes with insufficient glycemic control.

Completed
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2013

At a glance

  • Drugs Linagliptin (Primary) ; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • 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.
    • 18 Nov 2008 Actual patient enrollment was 302, as reported by clinicaltrials.gov.
    • 18 Nov 2008 The actual date of final data collection for the primary outcome was Aug 2007, as reported by clinicaltrials.gov.
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