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

Primary Purpose

Impaired Glucose Tolerance

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exenatide
Metformin
Sponsored by
St. Paul Heart Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • International Diabetes Center at Park Nicollet
  • St. Paul Heart Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exenatide

Metformin

Arm Description

Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.

Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2007
Last Updated
September 5, 2013
Sponsor
St. Paul Heart Clinic
Collaborators
Amylin Pharmaceuticals, LLC., Eli Lilly and Company, International Diabetes Center at Park Nicollet
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1. Study Identification

Unique Protocol Identification Number
NCT00546728
Brief Title
The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes
Official Title
The Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Paul Heart Clinic
Collaborators
Amylin Pharmaceuticals, LLC., Eli Lilly and Company, International Diabetes Center at Park Nicollet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide
Arm Type
Experimental
Arm Description
Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Intervention Description
exenatide 10 mcg twice daily
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
metformin 500 twice daily
Primary Outcome Measure Information:
Title
Change in Reactive Hyperemic Index Over the 3-month Treatment Period
Description
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.
Time Frame
Change from baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron S. Kelly, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Diabetes Center at Park Nicollet
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
St. Paul Heart Clinic
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22681705
Citation
Kelly AS, Bergenstal RM, Gonzalez-Campoy JM, Katz H, Bank AJ. Effects of exenatide vs. metformin on endothelial function in obese patients with pre-diabetes: a randomized trial. Cardiovasc Diabetol. 2012 Jun 8;11:64. doi: 10.1186/1475-2840-11-64.
Results Reference
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The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

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