Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

NCT00603239 · Completed

Last updated 2026-05-28

This clinical trial tested the safety and effects of the medication exenatide in adults with type 2 diabetes who were already taking a thiazolidinedione, with or without metformin.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 165 people

Who can join Ages 18+ · all sexes

Timeline Started 2008-01 · est. completion 2009-07

Where 25 sites · Canada, Mexico, Romania, South Africa, United States

What this study is testing ClinicalTrials.gov NCT00603239 ↗

Description as written by the study sponsor.

This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.

Treatments tested

exenatide also known as Byetta Drug

subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID)
placebo Drug

subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day

Main thing measured	Change in Glycosylated Hemoglobin (HbA1c)
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00603239 ↗