CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 820 enrolled
Drug / intervention
exenatide once weekly +3 moredrug
Likely dose
exenatide once weekly 2mgfrom 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/NCT00676338
NCT00676338Phase 3Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted May 13, 2008·Updated Apr 9, 2015

In Brief

A Phase 3 clinical trial evaluating exenatide once weekly, metformin, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 820 participants across 106 sites in 22 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesArgentina, 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
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 13, 2008
Enrollment StartNov 1, 2008
Primary CompletionJul 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.1 years ago

Interventions

exenatide once weeklydrug

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

metformindrug

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

sitagliptindrug

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

pioglitazonedrug

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