A phase III randomised, double-blind parallel group extension study to investigate the safety and efficacy of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46 [EXTENSION OF 700039451]

Trial Profile

A phase III randomised, double-blind parallel group extension study to investigate the safety and efficacy of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46 [EXTENSION OF 700039451]

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Linagliptin (Primary) ; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions
  • Sponsors Boehringer Ingelheim GmbH International; Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 11 Dec 2013 New source identified and integrated (ClinicalTrials.gov record; NCT00915772)
    • 10 Apr 2013 New source identified and integrated (Clinical Trials Registry - India; CTRI2009-091-000950).
    • 14 Feb 2013 New trial record
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