NCT00198146

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2007

Completed
Last Updated

August 11, 2020

Status Verified

September 1, 2005

Enrollment Period

6.7 years

First QC Date

September 12, 2005

Last Update Submit

August 10, 2020

Conditions

Newly Diagnosed With Type 1 Diabetes

Outcome Measures

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 (2)

  • HbA1c

  • Insulin requirements (units/kg/day)

Interventions

ZenapaxDRUG

Eligibility Criteria

Age2 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University - Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Daclizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mark D Pescovitz, M.D.

    Indiana University - Riley Hospital for Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

July 1, 2000

Primary Completion

February 23, 2007

Study Completion

February 23, 2007

Last Updated

August 11, 2020

Record last verified: 2005-09

Locations

US(1)