Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments itca 650, itca placebo
Phase phase 3
Sponsor Intarcia Therapeutics
Start date March 2013
End date July 2018
Trial size 4000 participants
Trial identifier NCT01455896, ITCA 650-CLP-107

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ITCA 650 is exenatide in DUROS
itca 650
ITCA 650
(Other)
itca placebo
ITCA placebo

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - HBA1c > 6.5% - History of coronary, cerebrovascular or peripheral artery disease Exclusion Criteria: - history of pancreatitis

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Intarcia Therapeutics.