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

NCT01455896 on ClinicalTrials.gov · last registry update 2017-01-27

An unusually large phase 3: 4,156 participants, more than double the 424 typical for the stage. Completed March 2016. exenatide is already approved in the US for type 2 diabetes, so this is asking a further question rather than establishing the drug works at all.

Status: COMPLETED
Phase: P3
Drug: exenatide
Bydureon, Byetta
Sponsor: Intarcia Therapeutics
Sponsor type: Industry
Enrollment: 4,156
Started: 2013-03
Primary completion: 2016-03 actual

Observed history

No changes recorded since monitoring began on 2026-08-21. This record has held steady. If a reporting date moves, a status changes or enrollment is resized, it will appear here with the previous value alongside the new one.

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),

Conditions studied

Type 2 Diabetes

Every field above is taken directly from the registry record. See all detected changes across the class, or the exenatide page for this molecule’s full trial and approval history.