CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 691 enrolled
Drug / intervention
exenatide once weekly +1 moredrug
Likely dose
exenatide once weekly 2.0mgfrom 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/NCT00917267
NCT00917267Phase 3Completed
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A Comparator-Controlled Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control (HbA1c) and Safety in Asian Subjects With Type 2 Diabetes Mellitus Managed With Oral Antidiabetic Medications

AstraZeneca·interventional·Posted Jun 10, 2009·Updated Apr 9, 2015

In Brief

A Phase 3 clinical trial evaluating exenatide once weekly and exenatide twice daily for Type 2 Diabetes Mellitus. Completed, enrolled 691 participants across 42 sites in 5 countries.

Detailed Summary

Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesChina, India, Japan, South Korea, Taiwan
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 10, 2009
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2010
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.1 years ago

Interventions

exenatide once weeklydrug

2.0mg subcutaneous injection, once a week

exenatide twice dailydrug

5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)