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

• ClinicalTrials.gov Identifier: NCT01455896
• Recruitment Status: Completed
• First Posted: October 20, 2011
• Last Update Posted: January 27, 2017
• Sponsor: Intarcia Therapeutics
• Information provided by (Responsible Party): Intarcia Therapeutics

Tracking Information

• First Submitted Date: October 18, 2011
• First Posted Date: October 20, 2011
• Last Update Posted Date: January 27, 2017
• Actual Study Start Date: March 2013
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 19, 2011): 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), [ Time Frame: 2 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
• 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
• Brief Summary: Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Type 2 Diabetes

Intervention

• Drug: ITCA 650
  ITCA 650
• Other: ITCA placebo
  ITCA placebo

Study Arms

• Experimental: ITCA 650 60 mcg/day
  ITCA 650 is exenatide in DUROS
  Intervention: Drug: ITCA 650
• ITCA placebo
  Intervention: Other: ITCA placebo

Publications *

• 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.
• Wittbrodt 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 26, 2017): 4156
• Original Estimated Enrollment (submitted: October 19, 2011): 2000
• Actual Study Completion Date: March 2016
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• HBA1c > 6.5%
• History of coronary, cerebrovascular or peripheral artery disease

Exclusion Criteria:

• history of pancreatitis

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Denmark, Finland, Germany, Poland, Slovakia, South Africa, Turkey, United States

Administrative Information

• NCT Number: NCT01455896
• Other Study ID Numbers: ITCA 650-CLP-107
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Intarcia Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Intarcia Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Intarcia Therapeutics
• Verification Date: January 2017