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A Randomised, Double-Blind, Placebo Controlled, Parallel Group 24 Week Study to Assess the Efficacy and Safety of BI 1356 (5 mg) in Combination With 30 mg Pioglitazone (Both Administered Orally Once Daily), Compared to 30 mg Pioglitazone Plus Placebo in Drug Naive or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control

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Trial Profile

A Randomised, Double-Blind, Placebo Controlled, Parallel Group 24 Week Study to Assess the Efficacy and Safety of BI 1356 (5 mg) in Combination With 30 mg Pioglitazone (Both Administered Orally Once Daily), Compared to 30 mg Pioglitazone Plus Placebo in Drug Naive or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2021

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At a glance

  • Drugs Linagliptin (Primary) ; Pioglitazone
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 17 Aug 2017 Results (n=2065) of pooled analysis of this and other similar 15 studies assessing efficacy and safety based upon age, obesity, and renal function, published in the Advances in Therapy.
    • 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.
    • 02 May 2012 Planned number of patients changed from 375 to 750 as reported by European Clinical Trials Database.
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