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

This study has been completed.
Sponsor:
Collaborators:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
Aaron S. Kelly, Ph.D., University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00546728
First received: October 17, 2007
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Impaired Glucose Tolerance
Drug: Exenatide
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance

Resource links provided by NLM:


Further study details as provided by St. Paul Heart Clinic:

Primary Outcome Measures:
  • Change in Reactive Hyperemic Index Over the 3-month Treatment Period [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: October 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide
Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
Drug: Exenatide
exenatide 10 mcg twice daily
Active Comparator: Metformin
Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
Drug: Metformin
metformin 500 twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546728

Locations
United States, Minnesota
International Diabetes Center at Park Nicollet
St. Louis Park, Minnesota, United States, 55416
St. Paul Heart Clinic
St. Paul, Minnesota, United States, 55102
Sponsors and Collaborators
St. Paul Heart Clinic
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
International Diabetes Center at Park Nicollet
Investigators
Principal Investigator: Aaron S. Kelly, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by St. Paul Heart Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aaron S. Kelly, Ph.D., Assistant Professor, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00546728     History of Changes
Other Study ID Numbers: SPHC 2007-02
Study First Received: October 17, 2007
Results First Received: April 23, 2012
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014