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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01455896

Enrollment

4156

Registered

2011-10-20

Start date

2013-03-31

Completion date

2016-03-31

Last updated

2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

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

Interventions

DRUGITCA 650

ITCA 650

OTHERITCA placebo

ITCA placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* history of pancreatitis

Design outcomes

Primary

Measure	Time frame
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

Countries

Bulgaria, Denmark, Finland, Germany, Poland, Slovakia, South Africa, Turkey (Türkiye), United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026