Indiana University - Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Completed
NCT Number: NCT00198146
Prevention of Diabetes Progression Trial (PDPT)
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. Additional purposes of the study are to investigate the amount of drug in the children, how quickly it is eliminated from the blood, and analyze the effect of the drug on the immune reaction to diabetes.
Completed
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Conditions
Age range
2 year–40 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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
Treatment and study plan
Zenapax
DrugPrimary outcomes
-
Area under the curve, Glucagon Stimulation Testing for c-peptide measurements at 0, +6min and +10min intervals over 2 years
Secondary outcomes
-
HbA1c
-
Insulin requirements (units/kg/day)
Sponsors and collaborators
Lead sponsor
Indiana University
Other
Collaborators
- Facet Biotech
- Pescovitz, Mark D., M.D.
- Roche Pharma AG
Registry information
Official study title
PD Initiated/Prevention of Diabetes Progression Trial (PDPT) ZEN119
Important dates
- Study start
- 2000
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Sep 20, 2005
- Registry last updated
- Aug 11, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.