A Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control.

Trial Profile

A Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control.

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2017

At a glance

  • Drugs Linagliptin (Primary) ; Glimepiride
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • 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.
    • 10 Jun 2017 Biomarkers information updated
    • 26 Sep 2013 Results presented at the 49th Annual Meeting of the European Association for the Study of Diabetes.
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