Effect of Pioglitazone and Exenatide on Body Weight and Beta Cell Function

NCT00845182 · Completed

Last updated 2026-05-28

This clinical trial tests how the medications pioglitazone, exenatide, and their combination affect body weight in adults with type 2 diabetes, healthy individuals, and those with impaired glucose tolerance.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, single-blind treatment study

Participants 43 people

Who can join Ages 18–65 · all sexes Healthy volunteers accepted.

Timeline Started 2007-06 · est. completion 2010-07

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT00845182 ↗

Description as written by the study sponsor.

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.

Treatments tested

Pioglitazone also known as ACTOS Drug

Pioglitazone 15 mg/day for 1 month and then 45 mg/day for 5 months
Exenatide also known as BYETTA Drug

Exenatide 5mcg twice daily for 1 month, then 10mcg twice daily for 5 months
Pioglitazone and Exenatide also known as ACTOS, BYETTA Drug

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

Main thing measured	Effect of Pioglitazone, Exenatide and Combined Pioglitazone and Exenatide on Body Weight
Sponsor	The University of Texas Health Science Center at San Antonio
Conditions studied	Type 2 Diabetes, Healthy, Impaired Glucose Tolerance
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00845182 ↗