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OpenTrials
Completed

NCT Number: NCT00546728

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

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.

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Key information

Conditions

Impaired Glucose Tolerance Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

International Diabetes Center at Park Nicollet, Saint Louis Park, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

Drug

exenatide 10 mcg twice daily

metformin

Drug

metformin 500 twice daily

Primary outcomes

  1. Change in Reactive Hyperemic Index Over the 3-month Treatment Period

    Time frame: Change from baseline to 3 months

    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.

Sponsors and collaborators

Lead sponsor

St. Paul Heart Clinic

Other

Collaborators

  • Amylin Pharmaceuticals, LLC.
  • Eli Lilly and Company
  • International Diabetes Center at Park Nicollet

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 19, 2007
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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