At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 155 enrolled
Drug / intervention
Exenatide Injection +2 moredrug
Likely dose
Exenatide Injection 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.
Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating ITCA 650, Exenatide Injection, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 155 participants across 50 sites.
Detailed Summary
The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartAug 2009
Primary CompletionAug 2010
Study CompletionFeb 2011
TodayJul 2026
First PostedJul 22, 2009
Enrollment StartAug 1, 2009
Primary CompletionAug 1, 2010
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.9 years ago
Interventions
ITCA 650other
ITCA 650 (continuous delivery of exenatide in DUROS)
Exenatide Injectiondrug
twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks
Ex Inj/ITCA 650other
twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650