Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00004984 · ClinicalTrials.gov registry record · Phase 3
The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 711
- Enrollment target
NCT00004984: Completed Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00004984 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 711 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004984, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 711 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The rate of type 1 diabetes per year is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up. The diagnosis of diabetes is as defined by the American Diabetes Association (ADA) based on oral glucose testing or the presence of symptoms and unequivocal hyperglycemia.
Interventions
- DRUG Placebo
- DRUG Oral Insulin
- DRUG Parenteral Insulin
- OTHER Close Observation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 711 participants |
| Start Date | 1994-02 |
| Est. Completion | 2003-06 |
| Phase | Phase 3 |
What the finished NCT00004984 record still lists
NCT00004984 is an interventional study that assigns participants to a tested intervention. The registered 711 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00004984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004984 about?
NCT00004984 is a clinical study titled "The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)". 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. Subje...
What is the current status of trial NCT00004984?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 711 participants. The study started on 1994-02. Estimated completion is 2003-06.
What interventions are being tested in trial NCT00004984?
The interventions under investigation include: Placebo (DRUG), Oral Insulin (DRUG), Parenteral Insulin (DRUG), Close Observation (OTHER).
Who is sponsoring clinical trial NCT00004984?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004984's enrollment target sits among peer trials
711 501st of 2000 higher than 1,499 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06179160 · 710 participants · Phase 1
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- NCT06235697 · 710 participants · Phase 3
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
- NCT06470867 · 710 participants · NA
Randomized Controlled Effectiveness Trial of VA S.A.V.E.
- NCT07022483 · 710 participants · Phase 3
Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia