Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment



Status:Archived
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:March 2010

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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


The objective of the current study is to investigate the efficacy, safety and tolerability
of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or
previously treated type 2 diabetic patients with moderate to severe renal impairment and
insufficient glycaemic control. In addition safety in this patient population with longer
term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).



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