CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 76 enrolled
Drug / intervention
Exenatide SC +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01181986
NCT01181986Phase 4Completed

Exenatide and Postprandial Endothelial Dysfunction: Effects and Mechanisms

Carl T. Hayden VA Medical Center·interventional·Posted Aug 16, 2010·Updated May 20, 2014

In Brief

A Phase 4 clinical trial evaluating Exenatide SC, Exenatide IV, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 76 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 16, 2010
Enrollment StartAug 1, 2010
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.9 years ago

Interventions

Exenatide SCdrug

Exenatide 5-10 ug sc BID/10 days

Exenatide IVdrug

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

Placebo SCdrug

Placebo sc BID/10days

Exendin-9drug

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

Placebo IVdrug

Intravenous infusion for 45 minutes on 1 out of 3 visits