THIS TRIAL IS NOW CLOSED
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 abergin@bmctotalcare.com
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 ClinicalTrials.gov
For general inquiries, please contact the BMC Research Department at research@bmctotalcare.com or 877-692-8338.
