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Clinical Trials Detail

EXSCEL

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

IRB Protocol Number
10-0644

All Other Trials

  • Diabetes
  • Drugs (Pharmacology)
  • Heart & Circulation
Contact
Brad Wine at 720-848-5596
or bradley.wine@ucdenver.edu
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.

 

Please view this document for additional information.

Location

  • University of Colorado Hospital (UCH)
    12605 E. 16th Ave.
    Aurora, CO 80045