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Clinical Trials: EXSCEL (EXenatide Study of Cardiovascular Event Lowering Trial): A Randomized, Placebo-controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment with Exenatide Once Weekly in Patients with Type 2 Diabetes Mellitus

 


EXSCEL (EXenatide Study of Cardiovascular Event Lowering Trial): A Randomized, Placebo-controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment with Exenatide Once Weekly in Patients with Type 2 Diabetes Mellitus


EXSCEL

Trial Focus

Trial Focus

Diabetes, Drugs (Pharmacology), Heart & Circulation

Objective

        

IRB Protocol #

10-0644

Trial Status

Accepting Participants

Contact

Brad Wine at 720-848-5596 or bradley.wine@ucdenver.edu

Location

University of Colorado HospitalUniversity of Colorado Hospital

Eligibility and Other Participant Information


Inclusion Criteria:
•Type 2 diabetes mellitus
•Able to see a usual care provider at least twice a year
•HbA1c of ≤6.5 % and ≤ 10.0% 
•Patients with any level of CV risk (at least one of the following): •History of a major clinical manifestation of coronary artery disease i.e. myocardial infarction, surgical or percutaneous (balloon and/or stent) coronary revascularization procedure, or coronary angiography showing at least one stenosis ≥ 50% in a major epicardial artery or branch vessel.
•Ischemic cerebrovascular disease, including: - History of ischemic stroke; strokes not known to be hemorrhagic will be allowed as part of this criterion; transient ischemic attacks (TIAs) are not included;
•History of carotid arterial disease as documented by ≥50 % stenosis documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography, with or without symptoms of neurologic deficit.
•Atherosclerotic peripheral arterial disease, as documented by objective evidence such as amputation due to vascular disease, current symptoms of intermittent claudication confirmed by an ankle-brachial pressure index or toe brachial pressure index less than 0.9, or history of surgical or percutaneous revascularization procedure.

Exclusion Criteria:
•A diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
•Ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), EQW, VICTOZA (liraglutide), or taspoglutide.
•A planned or anticipated revascularization procedure.
•Pregnancy or planned pregnancy during the trial period.
•End-stage renal disease or an estimated glomerular filtration rate (eGFR) derived from serum creatinine (using the simple MDRD-4 formula) of <30 mL/min/1.73 m2. EQW is cleared through the kidneys.
•A known allergy or intolerance to exenatide.
•A history of gastroparesis. Exenatide slows gastric emptying.
•Personal or family history of medullary thyroid cancer or MEN2 (Multiple Endocrine Neoplasia Type 2.
•A history of pancreatitis.
•A history (≥ 2 episodes) of severe hypoglycemia within 12 months of enrollment.