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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004984
The ClinicalTrials.gov registry entry for NCT00004984 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 711 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00004984 reports 0 study locations.
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.
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