A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
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.
Eligibility Criteria
- - adult patients, >=18 years of age; - type 2 diabetes for >=1 month; - drug naive, or receiving stable doses of <=2 oral antihyperglycemic medications; - HbA1c 6.5-10.0% at screening; - symptomatic, stable NYHA class 2 heart failure at screening.
- - type 1 diabetes; - current or previous treatment with insulin; - uncontrolled hypertension; - NYHA class 1, 3 or 4 at screening.
Contact us to find out if this trial is right for you.
Contact
Debbie Slamowitz
6507232804
View on ClinicalTrials.gov
