GLPwatch
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
NCT01455896 · Completed
Last updated 2026-05-28This clinical trial is testing whether a medication called ITCA 650 can help reduce heart-related problems in adults with type 2 diabetes.
Status Completed The study has finished.
Phase Phase 3 Confirms effectiveness in a large group before approval.
Type Interventional (clinical trial)
Design Randomized, quadruple-blind treatment study
Participants 4,156 people
Who can join Ages 40+ · all sexes
Timeline Started 2013-03 · est. completion 2016-03
Where 42 sites · Bulgaria, Denmark, Finland, Germany, Poland, Slovakia, South Africa, Turkey (Türkiye), United States
What this study is testing ClinicalTrials.gov NCT01455896 ↗
Description as written by the study sponsor.
Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.
Treatments tested
- ITCA 650 Drug
ITCA 650
- ITCA placebo Other
ITCA placebo
| Main thing measured | 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), |
|---|---|
| Sponsor | Intarcia Therapeutics |
| Conditions studied | Type 2 Diabetes |
| GLP-1 drugs | — |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01455896 ↗