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UnknownPhase 4

Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus

Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

148

estimated

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

HbA1c 6.5-10%

Primary endpoint

Carotid plaque volume

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 IDNCT02162550
Org study ID1026

Timeline

Milestones

Study first posted2014-06-12estimated
Last update posted2018-06-14actual
Study start2014-06 (month precision)
Primary completion2019-04estimated (month precision)
Study completion2019-09estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

males and females of any race and ethnicity with T2DM, HbA1c of ≥6.5% and ≤10.0% on diet only
take stable doses of oral antihyperglycemic agents with or without long-acting insulin
must have a regular primary care provider (PCP) that is amenable to patient study participation and will facilitate (blinded to the treatment) the research team's study protocol efforts

Exclusion criteria

type 1 diabetes mellitus (T1DM)
current or recent glucagon-like peptide 1 receptor (GLP-1R) agonist use
contraindications to MRI (e.g., claustrophobia, ferromagnetic materials, body habitus inappropriate for MRI exam)
screening carotid ultrasound plaque thickness of <0.75 mm, prior or anticipated carotid stenting or endarterectomy
recent CVD (past 6 months) or other major illness or conditions affecting risk (e.g., pancreatitis, severe renal disease) or personal or family history of medullary thyroid carcinoma
patients with Multiple Endocrine Neoplasia syndrome type 2
serious hypersensitivity to exenatide or any product components
severe gastrointestinal disease, or pregnancy

Endpoints (3)

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.

Coverage by outcome category

Cardiometabolic biomarkers
2
Other (unclassified)
1

Cardiometabolic biomarkers

2 endpoints
Primary/protocol endpoint

Change in carotid plaque volume

Time frame:18 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in carotid plaque composition

Time frame:18 months

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in reactive hyperemic index

Time frame:18 months

change from baseline, improvement

Publications (1)

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

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.