Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
Phase 1
Completed
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: ITCA 650 (exenatide in DUROS)
- Registration Number
- NCT01798264
- Lead Sponsor
- Intarcia Therapeutics
- Brief Summary
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- type 2 diabetes >6 months
- stable diet & exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%
Exclusion Criteria
- prior treatment with exenatide
- history of pancreatitis
- history of medullary thyroid cancer or multiple endocrine neoplasia 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 mcg./day ITCA 650 (exenatide in DUROS) ITCA 650 (exenatide in DUROS) 20 mcg/day ITCA 650 (exenatide in DUROS) ITCA 650 (exenatide in DUROS) 40 mcg/day ITCA 650 (exenatide in DUROS) ITCA 650 (exenatide in DUROS) 80 mcg/day ITCA 650 (exenatide in DUROS) ITCA 650 (exenatide in DUROS)
- Primary Outcome Measures
Name Time Method Number of Subjects With Study Drug-Related Adverse Events 4 weeks
- Secondary Outcome Measures
Name Time Method To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus 4 weeks Change in HbA1c from baseline
Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline 4 weeks Change in Weight From Baseline to 4 Weeks 4 weeks
Trial Locations
- Locations (2)
Medpace Clinical Pharmacology Unit
🇺🇸Cincinnati, Ohio, United States
dGd Research
🇺🇸San Antonio, Texas, United States