A Randomized, Double Blind Study to Compare the Safety and Tolerability of Aleglitazar and Actos in Patients With Type 2 Diabetes and NYHA Class II Heart Failure.
This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : aleglitazar
Phase: Phase 2
Ages Eligible For Study:
- adult patients, >=18 years of age; - type 2 diabetes for >=1 month; - drug naive, or receiving stable doses of <=2 oral antihyperglycemic medications; - HbAlc 6.5-10.0% at screening; - symptomatic, stable NYHA class 2 heart failure at screening.