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

St. Paul Heart Clinic

Status and phase: Completed; Phase 4

Conditions: Impaired Glucose Tolerance

Treatments: Drug: Exenatide; Drug: Metformin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00546728

SPHC 2007-02

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Exenatide

Experimental group

Description:

Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.

Treatment:

Drug: Exenatide

Metformin

Active Comparator group

Description:

Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.

Treatment:

Drug: Metformin