Newly Diagnosed With Type 1 Diabetes
Conditions
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. 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.
Interventions
DRUGZenapax
Sponsors
Pescovitz, Mark D., M.D.
Roche Pharma AG
Facet Biotech
Indiana University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve, Glucagon Stimulation Testing for c-peptide measurements at 0, +6min and +10min intervals over 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c | — |
| Insulin requirements (units/kg/day) | — |
Countries
United States
Outcome results
None listed