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An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug.

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Trial Profile

An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 May 2014

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At a glance

  • Drugs Linagliptin (Primary) ; Alpha-glucosidase inhibitors; Biguanides; Meglitinide; Metformin; Sulfonylureas; Thiazolidinediones
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational
  • Sponsors Boehringer Ingelheim Pharmaceuticals

Most Recent Events

  • 22 Jan 2013 Biguanides, meglitinide, thiazolidinediones added as component of the treatment as reported by ClinicalTrials.gov.
  • 05 Oct 2012 Results presented at the 48th Annual Meeting of the European Association for the Study of Diabetes.
  • 16 Jan 2012 Actual patient number (574) added as reported by ClinicalTrials.gov.

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