Prevention of Diabetes Progression Trial (PDPT)

Indiana University School of Medicine

Status and phase

Completed

Phase 2

Conditions

Newly Diagnosed With Type 1 Diabetes

Treatments

Drug: Zenapax

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00198146

9910-34

Details and patient eligibility

About

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.

Sex

All

Ages

2 to 40 years old

Volunteers

No Healthy Volunteers

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