CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 467 enrolled
Drug / intervention
Exenatide Once Weekly +1 moredrug
Likely dose
Exenatide Once Weekly 2.0mcgfrom 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/NCT00641056
NCT00641056Phase 3Completed

Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea

AstraZeneca·interventional·Posted Mar 21, 2008·Updated Jun 15, 2015

In Brief

A Phase 3 clinical trial evaluating Exenatide Once Weekly and Insulin Glargine for Type 2 Diabetes Mellitus. Completed, enrolled 467 participants across 75 sites in 16 countries.

Detailed Summary

The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Mexico, Netherlands, Puerto Rico, Russia, South Korea, Spain, Taiwan, United States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 21, 2008
Enrollment StartApr 1, 2008
Primary CompletionMay 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.3 years ago

Interventions

Exenatide Once Weeklydrug

subcutaneous injection, 2.0mcg, once weekly

Insulin Glarginedrug

subcutaneous injection, variable dose, QD