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

Overview[ - collapse ][ - ]

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.
ConditionImpaired Glucose Tolerance
InterventionDrug: Exenatide
Drug: Metformin
PhasePhase 4
SponsorSt. Paul Heart Clinic
Responsible PartySt. Paul Heart Clinic
ClinicalTrials.gov IdentifierNCT00546728
First ReceivedOctober 17, 2007
Last UpdatedSeptember 5, 2013
Last verifiedSeptember 2013

Tracking Information[ + expand ][ + ]

First Received DateOctober 17, 2007
Last Updated DateSeptember 5, 2013
Start DateOctober 2007
Estimated Primary Completion DateJuly 2011
Current Primary Outcome MeasuresChange 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.
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleThe Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes
Official TitleThe Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance
Brief 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionImpaired Glucose Tolerance
InterventionDrug: Exenatide
exenatide 10 mcg twice daily
Drug: Metformin
metformin 500 twice daily
Study Arm (s)
  • Experimental: Exenatide
    Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
  • Active Comparator: Metformin
    Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment50
Estimated Completion DateJuly 2011
Estimated Primary Completion DateJuly 2011
Eligibility 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00546728
Other Study ID NumbersSPHC 2007-02
Has Data Monitoring CommitteeNo
Information Provided BySt. Paul Heart Clinic
Study SponsorSt. Paul Heart Clinic
CollaboratorsAmylin 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
Verification DateSeptember 2013

Locations[ + expand ][ + ]

International Diabetes Center at Park Nicollet
St. Louis Park, Minnesota, United States, 55416
St. Paul Heart Clinic
St. Paul, Minnesota, United States, 55102