A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c
NCT ID: NCT01785771
Last Updated: 2019-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
100 participants
INTERVENTIONAL
2013-05-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ITCA 650
ITCA 650 (exenatide in DUROS)
Interventions
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ITCA 650 (exenatide in DUROS)
Eligibility Criteria
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Inclusion Criteria
* 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%
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Intarcia Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
University Clinical Investigatons, Inc/Diabetes Research Center
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Colorado Springs Health Partners-Briargate
Colorado Springs, Colorado, United States
Meridien Research
Bradenton, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
New Horizon Research Center, Inc.
Miami, Florida, United States
International Research Assocaites, LLC
Miami, Florida, United States
Harmony Clinical Research, Inc.
North Miami Beach, Florida, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, United States
Andres Patron, D.O., P.A.
Pembroke Pines, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Perimeter Institute for Clinical Research PRIME
Atlanta, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
Chicago Research Center
Chicago, Illinois, United States
American Health Network of Indiana, LLC
Avon, Indiana, United States
Medisphere Medical Research Center, LLC
Evansville, Indiana, United States
American Health Network of Indiana
Franklin, Indiana, United States
American Health Network of Indiana, LLC
Muncie, Indiana, United States
Bunyan Clinical Research
Valparaiso, Indiana, United States
Crescent City Clinical Research Center
Metairie, Louisiana, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
University of North Carolina at Chapel Hill
Durham, North Carolina, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, 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
Lynn Institute of Norman
Norman, Oklahoma, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Greer, South Carolina, United States
BMG The Endocrine Clinic
Memphis, Tennessee, United States
Tekton Research, Inc.
Austin, Texas, United States
3rd Coast Research Associates
Corpus Christi, Texas, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States
Galena Research
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Medstar Clinical Research and Associates
Houston, Texas, United States
Clinical Trials of Texas, Inc.
San Angelo, Texas, United States
Sound Healthcare
Port Orchard, Washington, United States
Ranier Clinical Research Center
Renton, Washington, United States
Countries
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References
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Henry RR, Rosenstock J, Denham DS, Prabhakar P, Kjems L, Baron MA. Clinical Impact of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Uncontrolled Type 2 Diabetes and Very High Baseline HbA1c: The FREEDOM-1 HBL (High Baseline) Study. Diabetes Care. 2018 Mar;41(3):613-619. doi: 10.2337/dc17-1519. Epub 2018 Jan 4.
Other Identifiers
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ITCA 650-CLP-103-Sub-Study
Identifier Type: -
Identifier Source: org_study_id
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