A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes
NCT01455857 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460
Last updated 2015-08-18
Summary
Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.
Conditions
Interventions
- DRUG
-
ITCA 650
ITCA 650 is exenatide in DUROS
- OTHER
-
ITCA placebo
Formulation in DUROS (no exenatide)
Sponsors & Collaborators
-
Intarcia Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2014-08-31
- Completion
- 2014-09-30
Countries
- United States
Study Locations
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