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A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650

Information source: Intarcia Therapeutics
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: ITCA 650 (Drug); ITCA placebo (Other)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Intarcia Therapeutics

Summary

Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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),

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HBA1c > 6. 5%

- History of coronary, cerebrovascular or peripheral artery disease

Exclusion Criteria:

- history of pancreatitis

Locations and Contacts

Plovdiv 4002, Bulgaria

Hvidovre 2650, Denmark

Oulu 90100, Finland

Sopot 81-717, Poland

Martin 03659, Slovakia

Istanbul 34098, Turkey

Study Site, Chandler, Arizona 85224, United States

Intarcia Therapeutics, Inc, Hayward, California 94545, United States

Study Site, Long Beach, California 90806, United States

Study Site, Port Hueneme, California 93041, United States

Study SIte, San Diego, California 92114, United States

Study Site, Bradenton, Florida 34208, United States

Study Site, New Port Richey, Florida 34652, United States

Study Site, Palm Harbor, Florida 34684, United States

Johannesburg, Gauteng 2193, South Africa

Study Site, Chicago, Illinois 60634, United States

Study Site, Avon, Indiana 46123, United States

Study Site, Evansville, Indiana 47714, United States

Study Site, Franklin, Indiana 46131, United States

Study Site, Greenfield, Indiana 46140, United States

Study Site, Muncie, Indiana 47304, United States

Study Site, Newton, Kansas 67114, United States

Study Site, Wichita, Kansas 67205, United States

Study Site, Wichita, Kansas 67207, United States

Study Site, Metaire, Louisiana 70006, United States

Study Site, Rochester, Michigan 48307, United States

Study Site, St Louis, Missouri 63141, United States

Study Site, Billings, Montana 59101, United States

Las Vegas, Nevada 89148, United States

Study Site, Las Vegas, Nevada 89128, United States

Bad Lauterberg im Harz, Niedersachsen 37431, Germany

Study Site, Winston-Salem, North Carolina 27103, United States

Study Site, Cincinnati, Ohio 45236, United States

Study Site, Columbus, Ohio 43213, United States

Study Site, Franklin, Ohio 45005, United States

Study Site, Pittsburgh, Pennsylvania 15236, United States

Study Site, Uniontown, Pennsylvania 15401, United States

Study Site, Greer, South Carolina 29651, United States

Study Site, Austin, Texas 78745, United States

Dallas, Texas 75230, United States

Study Site, Dallas, Texas 75231, United States

Study Site, San Antonio, Texas 78229, United States

Additional Information

Starting date: March 2013
Last updated: July 29, 2015

Page last updated: August 20, 2015

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