This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7,226
aleglitazar 150 micrograms po daily
placebo control po daily
Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
Time frame: Throughout study, approximately 4.5 years
Effects on other cardiovascular endpoints
Time frame: Throughout study, approximately 4.5 years
Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk
Time frame: Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter
Tolerability and long-term safety profile
Time frame: Throughout study, approximately 4.5 years
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Mobile, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
...and 800 more locations