At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Glimepiride, Placebo, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 241 participants across 52 sites in 9 countries.
Detailed 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).
Study Details
Timeline
Interventions
1-4 mg daily after 12 weeks
Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily
Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment
Placebo mach to 5 mg linagliptin once daily after 12 weeks
5 mg once daily