At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 165 enrolled
Drug / intervention
exenatide +1 moredrug
Likely dose
exenatide 5 mcgfrom 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.
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin
In Brief
A Phase 3 clinical trial evaluating exenatide and placebo for Type 2 Diabetes Mellitus. Completed, enrolled 165 participants across 25 sites in 5 countries.
Detailed Summary
This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesCanada, Mexico, Romania, South Africa, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedJan 2008
Primary CompletionJul 2009
TodayJul 2026
First PostedJan 29, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.4 years ago
Interventions
exenatidedrug
subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID)
placebodrug
subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day