CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Exenatide +3 moredrug
Likely dose
Exenatide 10 mcgfrom 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/NCT02104739
NCT02104739Phase 4Completed
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Comparative Effects of Antidiabetic Medications on Postprandial Hyperlipidemia, Free Fatty Acid Signaling, and Endothelial Dysfunction in Individuals With Prediabetes

The University of Texas Health Science Center, Houston·interventional·Posted Apr 4, 2014·Updated Jul 3, 2018

In Brief

A Phase 4 clinical trial evaluating Exenatide, Saxagliptin, and 2 other interventions for Prediabetes and Obesity. Completed, enrolled 21 participants across 1 site.

Detailed Summary

This project addresses cardiovascular disease risk in patients with prediabetes. Levels of lipids after eating a meal ("postprandial lipids") are strong independent predictors of cardiovascular risk. Newer anti-diabetic agents - exenatide and saxagliptin - impact lipid metabolism. These medications will be studied for their effect in reducing both postprandial lipid levels and arterial dysfunction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrediabetes, Obesity
CountriesUnited States
CollaboratorsThe Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 4, 2014
Enrollment StartApr 1, 2014
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.2 years ago

Interventions

Exenatidedrug

Single subcutaneous injection (10 mcg)

Saxagliptindrug

Single dose orally (5 mg)

Exenatide extended-release (ER)drug

Subcutaneous injection (2mg) weekly for 6 weeks

Placeboother

Placebo tablets and Placebo (normal saline) injections