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Completed Phase 3 Interventional Accepts healthy volunteers

The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)

ClinicalTrials.gov ID: NCT00004984

Public ClinicalTrials.gov record NCT00004984. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 11:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The Diabetes Prevention Trial of Type 1 (DPT-1) was a multicenter randomized, controlled clinical trial designed to determine whether it is possible to delay or prevent the clinical onset of type 1 diabetes through daily doses of insulin in individuals determined to be at risk for the disease. Subjects were recruited from study clinics and through media campaigns.First-degree relatives, 3 to 45 years of age, and second-degree relatives, 3 to 20 years of age, of patients with diabetes were screened for islet-cell antibodies. Those individuals found to be at high risk of diabetes were randomized to receive either close observation or low-dose parenteral insulin. Those individuals found to be at intermediate risk of diabetes are randomized to receive insulin orally or to receive placebo. Patients were followed for up to six years.

Study identification

NCT ID
NCT00004984
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
711 participants

Conditions and interventions

Eligibility (public fields only)

Age range
3 Years to 45 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 1994
Primary completion
May 31, 2003
Completion
May 31, 2003
Last update posted
Apr 23, 2020

1994 – 2003

United States locations

U.S. sites
14
U.S. states
10
U.S. cities
13
Facility City State ZIP Site status
Childrens Hospital of Los Angeles, Division of Endocrinology Los Angeles California 90027
University of California-San Francisco, Milberry Union East RM 405, 500 Parnassus Ave Box 0136 San Francisco California 94143
Stanford University Stanford California 94305-5208
University of Colorado Barbara Davis Center for Childhood Diabetes Denver Colorado 80262
University of Florida Diabetes Research Center Gainesville Florida 32610-0296
DPT-1 Operations Coordinating Center Miami Florida 33136
University of Miami School of Medicine, Jackson Medical Tower Miami Florida 33136
Indiana University, James Whitcomb Riley Hospital for Children, 702 Barnhill Dr, Ste 5960 Indianapolis Indiana 46202
Joslin Diabetes Center Boston Massachusetts 02215
University of Minnesota Minneapolis Minnesota 55455
Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave New York New York 10032
Children's Hospital of Pittsburgh, Dept/Pediatric Endocrinology, 3705 5th Ave Pittsburgh Pennsylvania 15213
University of Texas, Children's Medical Center, 6300 Harry Hines Ste 1200 Dallas Texas 75235
Virginia Mason Research Center, 1201 Ninth Avenue Seattle Washington 98101

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00004984, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 23, 2020 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00004984 live on ClinicalTrials.gov.

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