drugset / Trial / NCT00461006

A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.

NCT00461006

Phase 2 Completed 176 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and efficacy parameters will be assessed at intervals during the treatment period. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Timeline

Start
2007-06
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pioglitazone Small molecule 45 mg Oral
Subject aleglitazar Small molecule 0.6 mg Oral