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CompletedPhase 4Results posted

The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

The Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance

Asset

Exenatide

GLP-1 agonist

Listed sites

2

Recruiting sites

Enrollment

50

actual

Study population

Obesity / overweight, Prediabetes / glucose intolerance

Key I/E criterion

Primary endpoint

Reactive Hyperemic Index Over the 3-month Treatment Period

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 IDNCT00546728
Org study IDSPHC 2007-02

Timeline

Milestones

Study first posted2007-10-19estimated
Last update posted2013-11-08estimated
Results first posted2013-11-08estimated
Study start2007-10 (month precision)
Primary completion2011-07actual (month precision)
Study completion2011-07actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Greater than or equal to 18 years old
Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose >140 mg/dL OR impaired fasting glucose: fasting glucose > or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c > or = 5.7%
Abdominal obesity: waist circumference >102 cm (men) and >88 cm (women)
Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study

Exclusion criteria

Type 2 diabetes
Current use of glycemic control medications within one month of randomization
Fasting glucose >126 mg/dL
Current use of weight loss medication
Previous weight loss surgery
History of severe gastrointestinal disease
Standard clinical contraindications to exenatide or metformin therapy
Unstable angina
Heart failure
Stroke or coronary artery bypass graft within 3 months of screening
Women who are currently pregnant or planning to become pregnant
Breastfeeding women
Clinically significant liver disease
Creatinine > 1.5 mg/dL
Hepatic function greater than 3 times upper limit of normal
Patients who are mentally incompetent and cannot sign a Patient Informed Consent

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.

Cardiometabolic biomarkers

1 endpoint
Primary/protocol endpoint

Change in Reactive Hyperemic Index Over the 3-month Treatment Period

Time frame:Change from baseline to 3 months

change from baseline, improvement

Posted result

GroupValue (mean), ratio95% CI
Exenatide0.01
Metformin-0.17

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 tableClinicalTrials.gov results section

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.