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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.

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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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jan 2022

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At a glance

  • Drugs Linagliptin (Primary) ; Glimepiride
  • Indications Type 2 diabetes mellitus
  • Focus 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).

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