At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 427 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.
Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s)
In Brief
A Phase 3 clinical trial evaluating exenatide once weekly and insulin glargine for Type 2 Diabetes Mellitus. Completed, enrolled 427 participants across 22 sites.
Detailed Summary
The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesJapan
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedJul 2009
Primary CompletionSep 2010
Study CompletionJul 2011
TodayJul 2026
First PostedJul 9, 2009
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2010
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.0 years ago
Interventions
exenatide once weeklydrug
subcutaneous injection, 2.0mg, once a week;
insulin glarginedrug
subcutaneous injection, titrated to achieve fasting serum glucose target, once a day