At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 456 enrolled
Drug / intervention
exenatidedrug
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.
An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating exenatide for Diabetes Mellitus, Type 2. Completed, enrolled 456 participants across 60 sites.
Detailed Summary
This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2002
First PostedMay 2005
Primary CompletionSep 2006
TodayJul 2026
First PostedMay 24, 2005
Enrollment StartNov 1, 2002
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 21.1 years ago
Interventions
exenatidedrug
subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination