Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT00943917
Last Updated: 2015-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2009-08-31
2011-02-28
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
NONE
Study Groups
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ITCA 650 20 mcg/day
ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
ITCA 650 40 mcg/day
ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
Exenatide Injection
Exenatide Injection
twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks
ITCA 650 20/20
ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
ITCA 650 20/60
ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
ITCA 650 40/40
ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
ITCA 650 40/80
ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
Ex Inj/ITCA 650 40
Ex Inj/ITCA 650
twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650
Ex Inj/ITCA 650 60
Ex Inj/ITCA 650
twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650
Interventions
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ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
Exenatide Injection
twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks
Ex Inj/ITCA 650
twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1
* On a stable (\> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;
* Fasting plasma glucose \< 240 mg/dL at Screening Visit 1
* HbA1c ≥ 7% and ≤ 10% at Screening Visit 1
Exclusion Criteria
* Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)
* History of type 1 diabetes and/or history of diabetic ketoacidosis
* Body mass index ≥ 40 kg/m2;
* History of organ transplantation
18 Years
70 Years
ALL
No
Sponsors
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Intarcia Therapeutics
INDUSTRY
Responsible Party
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Locations
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Study Site
Chino, California, United States
Study Site
La Jolla, California, United States
Study Site
National City, California, United States
Study Site
Sacramento, California, United States
Study Site
San Diego, California, United States
Study Site
Valley Village, California, United States
Study Site
Longmont, Colorado, United States
Study Site
Pueblo, Colorado, United States
Study Site
Bradenton, Florida, United States
Study Site
Miami, Florida, United States
Study Site
Miami, Florida, United States
Study Site
Miami, Florida, United States
Study Site
Miramar, Florida, United States
Study Site
Pembroke Pines, Florida, United States
Study Site
St. Petersburg, Florida, United States
Study Site
Atlanta, Georgia, United States
Study Site
Sandy Springs, Georgia, United States
Study Site
Meridian, Idaho, United States
Study Site
Chicago, Illinois, United States
Study Site
Avon, Indiana, United States
Study Site
Wichita, Kansas, United States
Study Site
Lexington, Kentucky, United States
Study Site
New Orleans, Louisiana, United States
Study Site
Kalamazoo, Michigan, United States
Study Site
Traverse City, Michigan, United States
Study Site
Troy, Michigan, United States
Study Site
Ypsilanti, Michigan, United States
Study Site
Minneapolis, Minnesota, United States
Study Site
Las Vegas, Nevada, United States
Study Site
New Hyde Park, New York, United States
Study Site
Charlotte, North Carolina, United States
Study Site
Hickory, North Carolina, United States
Study Site
Cincinnati, Ohio, United States
Study Site
Cincinnati, Ohio, United States
Study Site
Franklin, Ohio, United States
Study Site
Kettering, Ohio, United States
Study Site
Norman, Oklahoma, United States
Study Site
Eugene, Oregon, United States
Study Site
Rapid City, South Dakota, United States
Study Site
Austin, Texas, United States
Study Site
Austin, Texas, United States
Study Site
Dallas, Texas, United States
Study Site
Dallas, Texas, United States
Study Site
Irving, Texas, United States
Study Site
San Antonio, Texas, United States
Study Site
San Antonio, Texas, United States
Study Site
West Jordan, Utah, United States
Study Site
Norfolk, Virginia, United States
Study Site
Olympia, Washington, United States
Study Site
Spokane, Washington, United States
Countries
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References
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Henry RR, Rosenstock J, Logan DK, Alessi TR, Luskey K, Baron MA. Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes. Diabetes Care. 2013 Sep;36(9):2559-65. doi: 10.2337/dc12-2410. Epub 2013 May 3.
Other Identifiers
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ITCA 650-CLP-02
Identifier Type: -
Identifier Source: org_study_id
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