Status:
COMPLETED
Prevention of Diabetes Progression Trial (PDPT)
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Pescovitz, Mark D., M.D.
Roche Pharma AG
Conditions:
Newly Diagnosed With Type 1 Diabetes
Eligibility:
All Genders
2-40 years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to determine the efficacy and safety of daclizumab in preventing the progression of diabetes in children who have just been diagnosed with type I diabetes. Additio...
Eligibility Criteria
Inclusion
- Newly diagnosed type 1 diabetes without previous insulin or oral hypoglycemic therapy.
- ages 2 to 40 years at diagnosis
- enroll within 3 months of diagnosis
- test positive for at least one of the biochemical autoantibodies (ICA-512, GAD 65 or IAA) prior to enrolling
Exclusion
- Previous treatment with an anti-IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety and efficacy of daclizumab.
- Other immunosuppressive drugs including, but not limited to, corticosteroids, cyclosporine, tacrolimus, rapamycin, mycophenolate mofetil, or azathioprine.
- Active significant infection
- Limited life expectancy because of disease other than diabetes
- Pregnancy
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
End Date :
February 23 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00198146
Start Date
July 1 2000
End Date
February 23 2007
Last Update
August 11 2020
Active Locations (1)
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1
Indiana University - Riley Hospital for Children
Indianapolis, Indiana, United States, 46202