At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 254 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.
A Randomized, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating exenatide once weekly and exenatide twice daily for Type 2 Diabetes Mellitus. Completed, enrolled 254 participants across 41 sites.
Detailed Summary
This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedApr 2009
Primary CompletionOct 2009
Study CompletionJan 2010
TodayJul 2026
First PostedApr 8, 2009
Enrollment StartMar 1, 2009
Primary CompletionOct 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.2 years ago
Interventions
exenatide once weeklydrug
subcutaneous injection, 2.0mg, once a week
exenatide twice dailydrug
subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day