A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Patients Treated With Standard of Care for Type 2 Diabetes
1 other identifier
interventional
4,156
9 countries
42
Brief Summary
Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Mar 2013
Longer than P75 for phase_3 type-2-diabetes
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJanuary 27, 2017
January 1, 2017
3 years
October 18, 2011
January 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
ITCA 650 60 mcg/day
EXPERIMENTALITCA 650 is exenatide in DUROS
ITCA placebo
OTHERInterventions
Eligibility Criteria
You may qualify if:
- HBA1c \> 6.5%
- History of coronary, cerebrovascular or peripheral artery disease
You may not qualify if:
- history of pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
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
Unknown Facility
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
Unknown Facility
Dallas, Texas, 75230, United States
Study Site
Dallas, Texas, 75231, United States
Study Site
San Antonio, Texas, 78229, United States
Unknown Facility
Plovdiv, 4002, Bulgaria
Unknown Facility
Hvidovre, 2650, Denmark
Unknown Facility
Oulu, 90100, Finland
Unknown Facility
Bad Lauterberg im Harz, Lower Saxony, 37431, Germany
Unknown Facility
Sopot, 81-717, Poland
Unknown Facility
Martin, 03659, Slovakia
Unknown Facility
Johannesburg, Gauteng, 2193, South Africa
Unknown Facility
Istanbul, 34098, Turkey (Türkiye)
Related Publications (2)
Ruff CT, Baron M, Im K, O'Donoghue ML, Fiedorek FT, Sabatine MS. Subcutaneous infusion of exenatide and cardiovascular outcomes in type 2 diabetes: a non-inferiority randomized controlled trial. Nat Med. 2022 Jan;28(1):89-95. doi: 10.1038/s41591-021-01584-3. Epub 2021 Dec 6.
PMID: 34873344DERIVEDWittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
PMID: 29693361DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2011
First Posted
October 20, 2011
Study Start
March 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
January 27, 2017
Record last verified: 2017-01