drugset / Trial / NCT01398267

A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril

NCT01398267

Phase 1 Completed 55 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blind

Summary

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effect of aleglitazar on renal function, the renin-angiotensin system and the pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to lisinopril for 4 weeks.

Timeline

Start
2011-08
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject LISINOPRIL ANHYDROUS Small molecule 20 mg Oral
Subject aleglitazar Small molecule 150 ug Oral