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Therapeutic Areas: Endocrinology | Family Medicine
Disease Category: Diabetes Mellitus Types I and II
Location: United States, PA
Clinical Trial Details
Research Study Summary
This study will compare the impact of including exenatide once weekly as part of usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary cardiovascular combined endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.
Patient Inclusion Criteria:
- Patient has type 2 diabetes mellitus
- Patient has an HbA1c of ≥ 7.0 % and ≤ 10.0% on stable doses of up to three oral antihyperglycemic agents for at least 3 months (i.e. no oral antihyperglycemic agent adjustments in the past 3 months)
- Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
Patient Exclusion Criteria:
- Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
- Patient has taken insulin within 2 weeks of screening visit or for greater than 1 week within 3 months of screening visit.
- Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), Exenatide Once Weekly, VICTOZA (liraglutide), or taspoglutide.
- Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
- Patient has a planned or anticipated revascularization procedure.
- Pregnancy or planned pregnancy during the trial period.
- Patient has previously been enrolled in EXenatide Study of Cardiovascular Event Lowering (EXSCEL).
To Learn more
Both Male and Female
Date Last Changed:
July 18, 2013
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