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A randomised, double-blind parallel group study to compare the efficacy and safety of initial combination therapy with linagliptin 5 mg + pioglitazone 15 mg, 30 mg, or 45 mg, vs. monotherapy with pioglitazone (15 mg, 30 mg, or 45 mg) or linagliptin 5 mg once daily for 30 weeks, followed by blinded trial period on linagliptin 5 mg + pioglitazone 30 or 45 mg versus pioglitazone monotherapy 30 or 45 mg or linagliptin 5 mg for up to 54 weeks in type 2 diabetic patients with insufficient glycaemic control on diet and exercise.

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Trial Profile

A randomised, double-blind parallel group study to compare the efficacy and safety of initial combination therapy with linagliptin 5 mg + pioglitazone 15 mg, 30 mg, or 45 mg, vs. monotherapy with pioglitazone (15 mg, 30 mg, or 45 mg) or linagliptin 5 mg once daily for 30 weeks, followed by blinded trial period on linagliptin 5 mg + pioglitazone 30 or 45 mg versus pioglitazone monotherapy 30 or 45 mg or linagliptin 5 mg for up to 54 weeks in type 2 diabetic patients with insufficient glycaemic control on diet and exercise.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2019

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At a glance

  • Drugs Linagliptin/pioglitazone (Primary) ; Linagliptin; Pioglitazone
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals

    • Most Recent Events

    • 16 Sep 2014 Primary endpoint 'change in HbA1c at 30 weeks of treatment' has been met for the 5/30 and 5/45 mg/day linagliptin/pioglitazone combinations according to results presented at the 50th Annual Meeting of the European Association for the Study of Diabetes.
    • 16 Sep 2014 Results presented at the 50th Annual Meeting of the European Association for the Study of Diabetes.
    • 05 Jul 2013 Status changed from suspended to completed as reported by United Kingdom Clinical Research Network.
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