Prevention of Diabetes Progression Trial (PDPT)

• Sponsor: Indiana University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00198146
• Collaborator: Pescovitz, Mark D., M.D. (Other), Roche Pharma AG (Industry), Facet Biotech (Industry)
• Enrollment: 40
• Location: 1
• Duration (Months): 79.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Newly Diagnosed With Type 1 Diabetes	Drug: Zenapax	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: PD Initiated/Prevention of Diabetes Progression Trial (PDPT) ZEN119
• Study Start Date: Jul 1, 2000
• Actual Primary Completion Date: Feb 23, 2007
• Actual Study Completion Date: Feb 23, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. HbA1c []

2. Insulin requirements (units/kg/day) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University - Riley Hospital for Children	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University School of Medicine
• Pescovitz, Mark D., M.D.
• Roche Pharma AG
• Facet Biotech

Investigators

• Principal Investigator: Mark D Pescovitz, M.D., Indiana University - Riley Hospital for Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00198146
• Other Study ID Numbers: 9910-34
• First Posted: Sep 20, 2005
• Last Update Posted: Aug 11, 2020
• Last Verified: Sep 1, 2005

• Additional relevant MeSH terms: Diabetes Mellitus; Daclizumab

Study Results

No Results Posted as of Aug 11, 2020