This randomized, double-blind, placebo-controlled study will evaluate the potential of aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in patients with type 2 diabetes mellitus and chronic kidney disease. Patients will be randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated time on study treatment is approximately 3 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Aleglitazar 150 mcg oral doses, once a day for approximately 3 years
Matching placebo to aleglitazar, once a day for approximately 3 years
Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death
Time frame: Approximately 5 years
Time to the first occurrence of any component of major adverse cardiovascular event composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
Time frame: Approximately 5 years
Time to the first occurrence of any component of macrovascular composite (CV death, non fatal myocardial infarction, hospitalization for unstable angina, non fatal stroke)
Time frame: Approximately 5 years
Time to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality
Time frame: Approximately 5 years
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