drugset / Trial / NCT01087502

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

NCT01087502

Phase 3 Completed 241 enrolled Boehringer Ingelheim Eli Lilly and Company · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

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).

Timeline

Start
2010-03
Primary completion
2012-05
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glimepiride Small molecule
Subject Linagliptin Small molecule 5 mg Oral