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

NCT ID: NCT00546728

Last Updated: 2013-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-07-31

Brief Summary

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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

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Conditions

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Impaired Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exenatide

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

Group Type EXPERIMENTAL

Exenatide

Intervention Type DRUG

exenatide 10 mcg twice daily

Metformin

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

metformin 500 twice daily

Interventions

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Exenatide

exenatide 10 mcg twice daily

Intervention Type DRUG

Metformin

metformin 500 twice daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amylin Pharmaceuticals, LLC.

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

International Diabetes Center at Park Nicollet

OTHER

Sponsor Role collaborator

St. Paul Heart Clinic

OTHER

Sponsor Role lead

Responsible Party

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Aaron S. Kelly, Ph.D.

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aaron S. Kelly, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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International Diabetes Center at Park Nicollet

Saint Louis Park, Minnesota, United States

Site Status

St. Paul Heart Clinic

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22681705 (View on PubMed)

Other Identifiers

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SPHC 2007-02

Identifier Type: -

Identifier Source: org_study_id