CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Exenatide +1 moredrug
Likely dose
Exenatide 10 microgramsfrom 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/NCT01951651
NCT01951651Phase 4Completed

Effect of Exenatide Treatment on Myocardial Fat Content, Left Ventricular Function, and Vascular Inflammation in Patients With Type 2 Diabetes Mellitus

Baylor College of Medicine·interventional·Posted Sep 26, 2013·Updated May 16, 2016

In Brief

A Phase 4 clinical trial evaluating Exenatide and Glipizide for Type 2 Diabetes Mellitus. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the effect of exenatide on liver and heart (myocardial) fat and inflammation.

Study Details

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

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 26, 2013
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.8 years ago

Interventions

Exenatidedrug

Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months.

Glipizidedrug

Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months.