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

Completed · Phase 4

Conditions studied: Impaired Glucose Tolerance

In brief

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.

Key facts

Study ID

NCT00546728

Run by

St. Paul Heart Clinic

People needed

50

Starts

2007-10-01

Expected to finish

2011-07-01

Last updated by the study team

2013-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• International Diabetes Center at Park Nicollet — Saint Louis Park, Minnesota, United States
• St. Paul Heart Clinic — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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