Type 2 Diabetes Clinical Trial
Official title:
A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Patients Treated With Standard of Care for Type 2 Diabetes
| Verified date | January 2017 |
| Source | Intarcia Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.
| Status | Completed |
| Enrollment | 4156 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - HBA1c > 6.5% - History of coronary, cerebrovascular or peripheral artery disease Exclusion Criteria: - history of pancreatitis |
| Country | Name | City | State |
|---|---|---|---|
| United States | Study Site | Austin | Texas |
| United States | Study Site | Avon | Indiana |
| United States | Study Site | Billings | Montana |
| United States | Study Site | Bradenton | Florida |
| United States | Study Site | Chandler | Arizona |
| United States | Study Site | Chicago | Illinois |
| United States | Study Site | Cincinnati | Ohio |
| United States | Study Site | Columbus | Ohio |
| United States | Study Site | Dallas | Texas |
| United States | Study Site | Evansville | Indiana |
| United States | Study Site | Franklin | Indiana |
| United States | Study Site | Franklin | Ohio |
| United States | Study Site | Greenfield | Indiana |
| United States | Study Site | Greer | South Carolina |
| United States | Intarcia Therapeutics, Inc | Hayward | California |
| United States | Study Site | Las Vegas | Nevada |
| United States | Study Site | Long Beach | California |
| United States | Study Site | Metaire | Louisiana |
| United States | Study Site | Muncie | Indiana |
| United States | Study Site | New Port Richey | Florida |
| United States | Study Site | Newton | Kansas |
| United States | Study Site | Palm Harbor | Florida |
| United States | Study Site | Pittsburgh | Pennsylvania |
| United States | Study Site | Port Hueneme | California |
| United States | Study Site | Rochester | Michigan |
| United States | Study Site | San Antonio | Texas |
| United States | Study SIte | San Diego | California |
| United States | Study Site | St Louis | Missouri |
| United States | Study Site | Uniontown | Pennsylvania |
| United States | Study Site | Wichita | Kansas |
| United States | Study Site | Wichita | Kansas |
| United States | Study Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Intarcia Therapeutics |
United States, Bulgaria, Denmark, Finland, Germany, Poland, Slovakia, South Africa, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | time to first occurrence of any event included in the MACE cardiovascular composite endpoint (CV death, non fatal MI, non fatal stroke, or hospitalization for unstable angina), | 2 years |
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