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)
Desert Clinical Research
🇺🇸Mesa, Arizona, United States
Rocks Medical Research Institute, Inc.
🇺🇸Fresno, California, United States
Rocks Medical Research Institute
🇺🇸Fresno, California, United States
Meridien Research
🇺🇸Bradenton, Florida, United States
Andres Patron, D.O., P.A.
🇺🇸Pembroke Pines, Florida, United States
University of North Carolina at Chapel Hill
🇺🇸Durham, North Carolina, United States
Sentral Clinical Research Services, LLC
🇺🇸Cincinnati, Ohio, United States
Columbus Clinical Research
🇺🇸Columbus, Ohio, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
3rd Coast Research Associates
🇺🇸Corpus Christi, Texas, United States
Dallas Diabetes and Endocrine Center
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Medstar Clinical Research and Associates
🇺🇸Houston, Texas, United States
Clinical Research Advantage, Inc.
🇺🇸Phoenix, Arizona, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
Fundamental Research
🇺🇸Gulf Shores, Alabama, United States
Perimeter Institute for Clinical Research PRIME
🇺🇸Atlanta, Georgia, United States
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Tekton Research, Inc.
🇺🇸Austin, Texas, United States
Galena Research
🇺🇸Dallas, Texas, United States
Sound Healthcare
🇺🇸Port Orchard, Washington, United States
East Valley Family Physicians, PLC
🇺🇸Chandler, Arizona, United States
eStudySite
🇺🇸Chula Vista, California, United States
Long Beach Center for Clinical Research
🇺🇸Long Beach, California, United States
Colorado Springs Health Partners-Briargate
🇺🇸Colorado Springs, Colorado, United States
Harmony Clinical Research, Inc.
🇺🇸North Miami Beach, Florida, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
American Health Network of Indiana, LLC
🇺🇸Muncie, Indiana, United States
Chicago Research Center
🇺🇸Chicago, Illinois, United States
American Health Network of Indiana
🇺🇸Franklin, Indiana, United States
Crescent City Clinical Research Center
🇺🇸Metairie, Louisiana, United States
Bunyan Clinical Research
🇺🇸Valparaiso, Indiana, United States
Palm Research Center, Inc.
🇺🇸Las Vegas, Nevada, United States
Clinical Trials of Texas, Inc.
🇺🇸San Angelo, Texas, United States
Ranier Clinical Research Center
🇺🇸Renton, Washington, United States
Palm Harbor Medical Associates
🇺🇸Palm Harbor, Florida, United States
Saviers Medical Group
🇺🇸Port Hueneme, California, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
BMG The Endocrine Clinic
🇺🇸Memphis, Tennessee, United States
University Clinical Investigatons, Inc/Diabetes Research Center
🇺🇸Tustin, California, United States
International Research Assocaites, LLC
🇺🇸Miami, Florida, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
New Horizon Research Center, Inc.
🇺🇸Miami, Florida, United States
East Coast Institute for Research, LLC
🇺🇸Jacksonville, Florida, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
PMG Research of Salisbury, LLC
🇺🇸Salisbury, North Carolina, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
Medisphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States