A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment

Summary

This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.

Timeline

Start

2010-05

Primary completion

2012-07

Completion

2012-07

Publications

• Ruilope L, Hanefeld M, Lincoff AM, Viberti G, Meyer-Reigner S, Mudie N, Wieczorek Kirk D, Malmberg K, Herz M. Effects of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on renal function in patients with stage 3 chronic kidney disease and type 2 diabetes: a Phase IIb, randomized study. BMC Nephrol. 2014 Nov 18;15:180. doi: 10.1186/1471-2369-15-180.

Drugs

Indications