A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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.|
- Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period. [ Designated as safety issue: No ]
- Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period., AEs, lab. parameters. Efficacy: Change from baseline to week 26 in HbAlc, FPG, FPI and lipid profile. [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
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|Study Director:||Clinical Trials||Hoffmann-La Roche|