GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

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

Lead sponsor

Intarcia Therapeutics

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

4,156

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

•HbA1c ≥6.5%

Primary endpoint

•4-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke, Unstable angina hospitalization)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01455896

Org study IDITCA 650-CLP-107

Timeline

Milestones

Study first posted2011-10-20estimated

Last update posted2017-01-27estimated

Study start2013-03actual (month precision)

Primary completion2016-03actual (month precision)

Study completion2016-03actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•HBA1c > 6.5%

•History of coronary, cerebrovascular or peripheral artery disease

Exclusion criteria

•history of pancreatitis

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Cardiovascular outcomes

1 endpoint

Primary/protocol endpoint

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

4-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Unstable angina hospitalization

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Subcutaneous infusion of exenatide and cardiovascular outcomes in type 2 diabetes: a non-inferiority randomized controlled trial.
Nature medicine2022 Jan (month)PMID34873344doi:10.1038/s41591-021-01584-3via clinicaltrials gov reference derived + pubmed nct search
Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population.
The American journal of managed care2018 Apr (month)PMID29693361via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.