Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

NCT00676338 · Completed

Last updated 2026-05-28

This clinical trial compared the effects of a weekly exenatide injection to metformin, a DPP-4 inhibitor, or a thiazolidinedione in adults with newly diagnosed type 2 diabetes to see how well each treatment lowered blood sugar over 26 weeks.

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 820 people

Who can join Ages 18+ · all sexes

Timeline Started 2008-11 · est. completion 2011-01

Where 106 sites · Argentina, Belgium, Brazil, Canada, France, Germany, Hungary, India, Israel, Italy, Mexico, Poland, Puerto Rico, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT00676338 ↗

Description as written by the study sponsor.

This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

Treatments tested

exenatide once weekly Drug

subcutaneous injection, 2mg, once weekly plus placebo oral once daily
metformin Drug

oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection
sitagliptin Drug

oral, 100 mg, daily plus placebo once weekly subcutaneous injection
pioglitazone Drug

oral, 30-45mg, daily plus placebo once weekly subcutaneous injection

Main thing measured	Change in HbA1c From Baseline to Week 26
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00676338 ↗