Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
NCT ID: NCT01798264
Last Updated: 2013-05-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2009-02-28
2009-05-31
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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10 mcg./day
ITCA 650 (exenatide in DUROS)
ITCA 650 (exenatide in DUROS)
20 mcg/day
ITCA 650 (exenatide in DUROS)
ITCA 650 (exenatide in DUROS)
40 mcg/day
ITCA 650 (exenatide in DUROS)
ITCA 650 (exenatide in DUROS)
80 mcg/day
ITCA 650 (exenatide in DUROS)
ITCA 650 (exenatide in DUROS)
Interventions
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ITCA 650 (exenatide in DUROS)
Eligibility Criteria
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Inclusion Criteria
* stable diet \& exercise, metformin, TZD or met + TZD HbA1c \>6.5% \<10.0%
Exclusion Criteria
* history of pancreatitis
* history of medullary thyroid cancer or multiple endocrine neoplasia 2
30 Years
70 Years
ALL
No
Sponsors
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Intarcia Therapeutics
INDUSTRY
Responsible Party
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Locations
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Miami Gardens, Florida, United States
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States
dGd Research
San Antonio, Texas, United States
Countries
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References
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Henry RR, Logan D, Alessi T, Baron MA. A randomized, open-label, multicenter, 4-week study to evaluate the tolerability and pharmacokinetics of ITCA 650 in patients with type 2 diabetes. Clin Ther. 2013 May;35(5):634-645.e1. doi: 10.1016/j.clinthera.2013.03.011. Epub 2013 Apr 8.
Other Identifiers
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ITCA 650-CLP-01
Identifier Type: -
Identifier Source: org_study_id
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