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

Impaired Glucose Tolerance Clinical Trial

Official title:

The Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546728
• Other study ID #: SPHC 2007-02
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2007
• Last updated: September 5, 2013
• Start date: October 2007
• Est. completion date: July 2011

Study information

• Verified date: September 2013
• Source: St. Paul Heart Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Drug:
• Exenatide
exenatide 10 mcg twice daily
• Metformin
metformin 500 twice daily

Locations

Country	Name	City	State
United States	International Diabetes Center at Park Nicollet	St. Louis Park	Minnesota
United States	St. Paul Heart Clinic	St. Paul	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
St. Paul Heart Clinic	Amylin Pharmaceuticals, LLC., Eli Lilly and Company, International Diabetes Center at Park Nicollet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Reactive Hyperemic Index Over the 3-month Treatment Period	Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.	Change from baseline to 3 months	No