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The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes

NCT01181986 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2014-05-20

Study results available
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Summary

The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes medication, will improve the function of the innermost part of the arterial wall called the endothelium after a fat-enriched meal and to determine how this occurs. The results of this study will help to determine and understand a novel action of this group of diabetes medications based on the action of naturally occuring gut substances called incretins. This may have a significant impact on cardiovascular health in patients with early and longstanding diabetes.

Conditions

Interventions

DRUG

Exenatide SC

Exenatide 5-10 ug sc BID/10 days

DRUG

Exenatide IV

50 ng/min intravenously for 45 minutes on 2 out of 3 study visits separated by 5-10 days

DRUG

Placebo SC

Placebo sc BID/10days

DRUG

Exendin-9

Primed (6,000 pM/kg), continuous (600 pM/kg) intravenous infusion for 75 minutes on 1 out of 3 study visits.

DRUG

Placebo IV

Intravenous infusion for 45 minutes on 1 out of 3 visits

Sponsors & Collaborators

Principal Investigators

  • Juraj Koska, MD, PhD · Phoenix VA Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01181986 on ClinicalTrials.gov