Phase 4 Completed N=50 Randomized Treatment

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

impaired glucose tolerance

Source: ClinicalTrials.gov NCT00546728 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2013

Primary outcomePrimary: Change in Reactive Hyperemic Index Over the 3-month Treatment Period — 0.01; -0.17 ratio

Summary

The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Reactive Hyperemic Index Over the 3-month Treatment Period	0.01; -0.17	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00546728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.