A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: ITCA 650 (exenatide in DUROS)
- Registration Number
- NCT01785771
- Lead Sponsor
- Intarcia Therapeutics
- Brief Summary
An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c \>10% \</=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
- Men or women age 18 to 80 years with type 2 diabetes
- On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs
- HbA1c >10.0% and ≤12.0%
- Prior treatment with any GLP-1 receptor agonist
- History of hypersensitivity to exenatide or liraglutide
- FPG >300 mg/dL
- History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
- Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- history of pancreatitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ITCA 650 ITCA 650 (exenatide in DUROS) -
- Primary Outcome Measures
Name Time Method Change in HbA1c between Week 39 and Day 0 39 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
Fundamental Research
🇺🇸Gulf Shores, Alabama, United States
East Valley Family Physicians, PLC
🇺🇸Chandler, Arizona, United States
Desert Clinical Research
🇺🇸Mesa, Arizona, United States
Clinical Research Advantage, Inc.
🇺🇸Phoenix, Arizona, United States
eStudySite
🇺🇸Chula Vista, California, United States
Rocks Medical Research Institute, Inc.
🇺🇸Fresno, California, United States
Rocks Medical Research Institute
🇺🇸Fresno, California, United States
Long Beach Center for Clinical Research
🇺🇸Long Beach, California, United States
Saviers Medical Group
🇺🇸Port Hueneme, California, United States
Scroll for more (39 remaining)Alabama Clinical Therapeutics, LLC🇺🇸Birmingham, Alabama, United States