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:

St. Paul Heart Clinic

ClinicalTrials.gov Identifier:

NCT00546728

First received: October 17, 2007

Last updated: August 17, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 17, 2007

Last Updated Date

August 17, 2011

Start Date ^ICMJE

October 2007

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Vascular endothelial function [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To compare the effects of exenatide versus metformin on arterial endothelial function, inflammation, oxidative stress, and biomarkers of endothelial activation in abdominally obese patients with IGT.

Change History

Complete list of historical versions of study NCT00546728 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Plasma biomarkers of inflammation and oxidative stress [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To compare the effects of acute administration of exenatide versus metformin on postprandial arterial endothelial function in abdominally obese patients with IGT.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The 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 Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Impaired Glucose Tolerance
Impaired Fasting Glucose

Intervention ^ICMJE

Drug: Exenatide
exenatide 10 mcg BID
Drug: Metformin
metformin 500 BID

Study Arm (s)

Experimental: Exenatide
Intervention: Drug: Exenatide
Active Comparator: Metformin
Intervention: Drug: Metformin

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Greater than or equal to 18 years old
Impaired glucose tolerance: 2-hr 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: ALT
Patients who are mentally incompetent and cannot sign a Patient Informed Consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00546728

Other Study ID Numbers ^ICMJE

SPHC 2007-02

Has Data Monitoring Committee

Responsible Party

St. Paul Heart Clinic

Study Sponsor ^ICMJE

St. Paul Heart Clinic

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Aaron S. Kelly, Ph.D.

University of Minnesota - Clinical and Translational Science Institute

Information Provided By

St. Paul Heart Clinic

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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