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Clinical Trial Details

Trial ID: L4064
Source ID: NCT01455896
Associated Drug: Itca 650
Title: A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: ITCA 650|OTHER: ITCA placebo
Outcome Measures: 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 |
Sponsor/Collaborators: Sponsor: Intarcia Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 4156
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-03
Completion Date: 2016-03
Results First Posted:
Last Update Posted: 2017-01-27
Locations: 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|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|Study Site, Las Vegas, Nevada, 89128, United States|Las Vegas, Nevada, 89148, United States|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|Plovdiv, 4002, Bulgaria|Hvidovre, 2650, Denmark|Oulu, 90100, Finland|Bad Lauterberg im Harz, Niedersachsen, 37431, Germany|Sopot, 81-717, Poland|Martin, 03659, Slovakia|Johannesburg, Gauteng, 2193, South Africa|Istanbul, 34098, Turkey
URL: https://clinicaltrials.gov/show/NCT01455896