A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes
NCT ID: NCT01455857
Last Updated: 2015-08-18
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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COMPLETED
PHASE3
460 participants
INTERVENTIONAL
2013-03-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ITCA 650 40 mcg/day
ITCA 650
ITCA 650 is exenatide in DUROS
ITCA 650 60 mcg/day
ITCA 650
ITCA 650 is exenatide in DUROS
ITCA placebo
ITCA placebo
Formulation in DUROS (no exenatide)
Interventions
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ITCA 650
ITCA 650 is exenatide in DUROS
ITCA placebo
Formulation in DUROS (no exenatide)
Eligibility Criteria
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Inclusion Criteria
* On diet \& exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU
* BMI between 25 \& 45 kg/m2
Exclusion Criteria
* 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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Study Site
Birmingham, Alabama, United States
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Gulf Shores, Alabama, United States
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Huntsville, Alabama, United States
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Chandler, Arizona, United States
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Goodyear, Arizona, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Chula Vista, California, United States
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Fresno, California, United States
Intarcia
Hayward, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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National City, California, United States
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Port Hueneme, California, United States
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San Jose, California, United States
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San Mateo, California, United States
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Tustin, California, United States
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Valley Village, California, United States
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Walnut Creek, California, United States
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Watsonville, California, United States
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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Boca Raton, Florida, United States
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Bradenton, Florida, United States
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Celebration, Florida, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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Daytona Beach, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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North Miami Beach, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Pembroke Pines, Florida, United States
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Ponte Vedra, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Canton, Georgia, United States
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Idaho Falls, Idaho, United States
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Meridian, Idaho, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evansville, Illinois, United States
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Avon, Indiana, United States
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Evansville, Indiana, United States
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Franklin, Indiana, United States
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Greenfield, Indiana, United States
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Muncie, Indiana, United States
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Valparaiso, Indiana, United States
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Des Moines, Iowa, United States
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Newton, Kansas, United States
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Metaire, Louisiana, United States
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Metairie, Louisiana, United States
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Metarie, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Brockton, Massachusetts, United States
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Rochester, Michigan, United States
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Ypsilanti, Michigan, United States
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Kansas City, Missouri, United States
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Billings, Montana, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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Endwell, New York, United States
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Staten Island, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Moorehead City, North Carolina, United States
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Mooresville, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Franklin, Ohio, United States
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Toledo, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Bend, Oregon, United States
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Uniontown, Pennsylvania, United States
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Greer, South Carolina, United States
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North Myrtle Beach, South Carolina, United States
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Dakota Dunes, South Dakota, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Carrolton, Texas, United States
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Corpus Cristi, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Angelo, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Tomball, Texas, United States
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Danville, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Port Orchard, Washington, United States
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Renton, Washington, United States
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Spokane, Washington, United States
Countries
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References
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Rosenstock J, Buse JB, Azeem R, Prabhakar P, Kjems L, Huang H, Baron MA. Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial. Diabetes Care. 2018 Feb;41(2):333-340. doi: 10.2337/dc17-1306. Epub 2017 Dec 14.
Other Identifiers
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ITCA 650-CLP-103
Identifier Type: -
Identifier Source: org_study_id
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