Primary outcome
What NCT00546728 measured first
| Exenatiden=25 | Metforminn=25 |
|---|---|
| 0.01(0.68) | -0.17(0.72) |
Phase 4 · Exenatide
NCT00546728 trial results
The Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance
Change in Reactive Hyperemic Index Over the 3-month Treatment Period (ratio), Change from baseline to 3 months. Exenatide: 0.01; Metformin: -0.17.
- Participants
- 50
- Status
- completed
- Completed
- 2011-07
- Sponsor
- St. Paul Heart Clinic
As posted on ClinicalTrials.gov (NCT00546728), updated at source Nov 8, 2013. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
The trial
How NCT00546728 was run
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.
- Exenatide: Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
- Metformin: Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
Who could join the trial
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
Published papers
Papers from NCT00546728
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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