A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Patients Treated With Standard of Care for Type 2 Diabetes

Investigator:  Mary F Carroll, MD

Status: Recruiting

Phase: 3

Sponsor: Intarcia Therapeutics

Contact: Anne Bergin, 541-706-6597 or

Location: Bend, Oregon (Central Oregon)

Purpose:  Evaluate whether a novel device, that releases Byetta (exenatide) under the skin, improves cardiovascular outcomes in patients with type 2 diabetes.

Inclusion Criteria:

  • Patients with a diagnosis of T2D for ≥3 months prior to Screening.
  • Patients with HbA1c ≥6.5% at Screening.
  • Males and females ≥40 years old with at least one documented occurrence of: CAD, cerebrovascular disease, or symptomatic peripheral arterial disease whose disease, in the Investigator’s opinion, is stable, and not in the acute recovery stage of a CV event

Exclusion Criteria:

  • Prior treatment with DPP-4 inhibitor or GLP-1 agonist or SGLT2 inhibitors (e.g. canagliflozin) within 3 months prior to Screening
  • Current treatment with rapid-acting insulin or rapid-acting insulin analogues
  • Requirement of treatment with immunosuppressants or medications that affect
    gastrointestinal (GI) motility
  • Allergic reactions or intolerance to GLP-1 receptor agonists
  • History of hypersensitivity to exenatide

See this trial at

For general inquiries, please contact the BMC Research Department at or 877-692-8338.

Back to Clinical Research


Post Comment