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CompletedNCT00198146Updated Aug 11, 2020

Prevention of Diabetes Progression Trial (PDPT)

A Phase 2 interventional study of Zenapax in Newly Diagnosed With Type 1 Diabetes, sponsored by Indiana University School of Medicine. Completed at 1 site in United States. Open to participants aged 2 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-08-11.

Sponsored by Indiana University School of Medicine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
2 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Newly Diagnosed With Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

This study's enrollment of 40 is close to the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Previous treatment with an anti-IL-2 directed monoclonal antibody or any other agent that would interfere with the ability to evaluate the safety and efficacy of daclizumab.
  • Other drugs including, but not limited to, , cyclosporine, tacrolimus, rapamycin, mycophenolate mofetil, or azathioprine.
  • Active significant infection
  • Limited because of disease other than diabetes
  • Pregnancy
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants

Interventions

06

What researchers measure

Primary outcomes

  1. Area under the curve, Glucagon Stimulation Testing for c-peptide measurements at 0, +6min and +10min intervals over 2 years

Secondary outcomes

  1. HbA1c

  2. Insulin requirements (units/kg/day)

07

Study locations

1 site
  • Indiana University - Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00198146
Lead sponsor
Indiana University School of Medicine
Collaborators
Pescovitz, Mark D., M.D., Roche Pharma AG, Facet Biotech
First posted
Sep 20, 2005
Start date
Jul 2000
Primary completion
Feb 23, 2007
Completion
Feb 23, 2007
Last update
Aug 11, 2020

Study contacts

Mark D Pescovitz, M.D.
principal investigator · Indiana University - Riley Hospital for Children
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Daclizumab

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