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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
14
Titrated to an individual maximum tolerated dose up to 45mg p.o. daily
Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily
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Jonesboro, Arkansas, United States
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Carmichael, California, United States
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Loma Linda, California, United States
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Long Beach, California, United States
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Jacksonville, Florida, United States
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Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.
Time frame: 26 week
Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters.
Time frame: 26 week
Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile.
Time frame: 26 week
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Slidell, Louisiana, United States
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Minneapolis, Minnesota, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
Unnamed facility
Tulsa, Oklahoma, United States
...and 35 more locations