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- To evaluate cardiovascular outcomes with lixisenatide compared to placebo [composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina] in type 2 diabetic patients who experienced an acute coronary syndrome (ACS) event, at least 5 days and no more than 12 weeks prior to the screening visit.
- To assess the effect of lixisenatide compared to placebo on:
- composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure
- composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or hospitalization for coronary revascularization procedure
- urinary albumin excretion (based on the urinary albumin/creatinine ratio)
- hemoglobin glycosylated (HbA1c)
- fasting plasma glucose (FPG)
- body weight
- cardiovascular risk markers: high-sensitivity C-reactive protein (hs-CRP), brain natriuretic peptide (BNP), N-terminal prohormone brain natriuretic peptide (NT-proBNPs).
- To assess the safety and tolerability of lixisenatide.
The estimated maximum study treatment duration will be approximately 41 months with about a 27 months of recruitment period.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Acute Coronary Syndrome
lixisenatide (AVE0010), placebo
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:12:48-0400
The primary objective of this study is to assess the efficacy of lixisenatide (AVE0010) on a composite endpoint of glycemic control (HbA1c) and body weight in comparison to sitagliptin as ...
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Cardiovascular disease (CVD)
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