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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Paul Heart Clinic
• Collaborators: Amylin Pharmaceuticals, LLC.; Eli Lilly and Company; International Diabetes Center at Park Nicollet
• Treatments: Exenatide; Metformin

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