NCT00546728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 8, 2013

Completed
Last Updated

November 8, 2013

Status Verified

September 1, 2013

Enrollment Period

3.8 years

First QC Date

October 17, 2007

Results QC Date

April 23, 2012

Last Update Submit

September 5, 2013

Conditions

Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline to 3 months

Study Arms (2)

Exenatide

EXPERIMENTAL

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

Drug: Exenatide

Metformin

ACTIVE COMPARATOR

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

Drug: Metformin

Interventions

ExenatideDRUG

exenatide 10 mcg twice daily

Exenatide
MetforminDRUG

metformin 500 twice daily

Metformin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

International Diabetes Center at Park Nicollet

Saint Louis Park, Minnesota, 55416, United States

Location

St. Paul Heart Clinic

Saint Paul, Minnesota, 55102, United States

Location

Related Publications (1)

  • 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.

    PMID: 22681705DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

ExenatideMetformin

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological FactorsBiguanidesGuanidinesAmidinesOrganic Chemicals

Limitations and Caveats

unblinded study design

Results Point of Contact

Title
Aaron S. Kelly, Ph.D.
Organization
University of Minnesota
kelly105@umn.edu
612-626-3492

Study Officials

  • Aaron S. Kelly, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 19, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 8, 2013

Results First Posted

November 8, 2013

Record last verified: 2013-09

Locations

US(2)