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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 ...
The purpose of this study is to evaluate the benefits and risks of AVE0010 in association with metformin in comparison to placebo, over a period of 24 weeks of treatment, followed by an ex...
The purpose of this study is to evaluate the benefits and risks of AVE0010 in association with sulfonylurea without or with metformin in comparison to placebo, over a period of 24 weeks of...
The purpose of this study is to evaluate the benefits and risks of AVE0010 in monotherapy in comparison to placebo, over a period of 12 weeks of treatment. The primary objective is to ass...
The purpose of this study is to evaluate the benefits and risks of AVE0010 in association with pioglitazone with or without metformin in comparison to placebo, over a period of 24 weeks of...
The results of the ELIXA trial demonstrated the cardiovascular safety of lixisenatide, a short-acting glucagon-like peptide-1 receptor agonist, in patients with type 2 diabetes and acute coronary synd...
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