Safety and Efficacy of INGAP-Peptide in Patients With Type 2 Diabetes
NCT ID: NCT00071422
Last Updated: 2014-07-11
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
PHASE2
126 participants
INTERVENTIONAL
2003-10-31
2004-06-30
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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placebo
1.5 mL SC injection, once daily for 90 days
placebo
1.5 mL, once daily, self-administered SC injection for 90 days
300 mg INGAP Peptide
1.5 mL SC injection, once daily for 90 days
INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
600 mg INGAP Peptide
1.5 mL SC injection, once daily for 90 days
INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
Interventions
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INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
placebo
1.5 mL, once daily, self-administered SC injection for 90 days
Eligibility Criteria
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Inclusion Criteria
* Using \>20 Units of insulin per day
* HbA1c from 6.5% to 10%
* No islet antibodies
* Otherwise healthy
35 Years
70 Years
ALL
No
Sponsors
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Exsulin Corporation
INDUSTRY
Responsible Party
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Procter and Gamble Pharmaceuticals
Locations
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Diabetes and Endocrine Associates
La Jolla, California, United States
VA Hospital UCSD
San Diego, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Denver, Colorado, United States
Longmont Medical Research Network
Longmont, Colorado, United States
MedStar Clinical Research Center
Washington D.C., District of Columbia, United States
Future Care Studies
Springfield, Massachusetts, United States
Mercury Street Medical
Butte, Montana, United States
Diabetes-Endocrinology Center of WNY
Buffalo, New York, United States
UNC Diabetes Care Center
Durham, North Carolina, United States
Piedmont Medical Group
Winston-Salem, North Carolina, United States
Clinical Research Institute of Southern Oregon
Medford, Oregon, United States
Mountain View Clinical Research
Greer, South Carolina, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States
University of Texas Health Science Center - Texas Diabetes Institute
San Antonio, Texas, United States
DGD Research Associates
San Antonio, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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2003069
Identifier Type: -
Identifier Source: org_study_id
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