CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
Pioglitazone +2 moredrug
Likely dose
Pioglitazone 15 mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00845182
NCT00845182Phase 4Completed

Effect of Pioglitazone With and Without Exenatide on Body Weight, Fat Topography, Beta Cell Function, and Glycemic Control in Type 2 Diabetic Patients

The University of Texas Health Science Center at San Antonio·interventional·Posted Feb 18, 2009·Updated Jan 18, 2018

In Brief

A Phase 4 clinical trial evaluating Pioglitazone, Exenatide, and 1 other intervention for Type 2 Diabetes and 2 related conditions. Completed, enrolled 43 participants across 1 site.

Detailed Summary

Pioglitazone, a drug used in treatment of type 2 diabetes has been shown to improve insulin sensitivity in skeletal muscle, liver, and fat cells. Despite the beneficial effects of pioglitazone to improve insulin sensitivity and reduce cardiovascular disease in high risk type 2 diabetic patients, weight gain has been a limiting factor. Exenatide, another agent used for treatment of T2DM, improves glycemic control and promotes moderate weight loss. In this proposal we will examine the effect of combination therapy with pioglitazone plus exenatide on body weight, fat topography, beta cell function, glycemic control, and plasma lipid levels in subjects with type 2 diabetes mellitus compared to treatment with each drug separately. Assessment of beta cell function will be performed by measuring the maximal insulin secretory capacity using a maximal hyperglycemic stimulus combined with an intravenous arginine stimulus.

Study Details

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

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 18, 2009
Enrollment StartJun 1, 2007
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.4 years ago

Interventions

Pioglitazonedrug

Pioglitazone 15 mg/day for 1 month and then 45 mg/day for 5 months

Exenatidedrug

Exenatide 5mcg twice daily for 1 month, then 10mcg twice daily for 5 months

Pioglitazone and Exenatidedrug

Pioglitazone 30mg daily for 1 month and then 45mg daily for 5 months and Exenatide 5mcg twice daily for one month then 10mcg twice daily for 5 months