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NCT00419562 · ClinicalTrials.gov registry record · Phase 3
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 560
- Enrollment target
NCT00419562 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 560 participants.
The verdict
NCT00419562, 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
- 560 participants
- Enrollment target
Study Summary
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. There is evidence suggesting that repeated oral administration of an autoantigen (the same protein that the immune system is reacting to) may introduce a protective immunity and cause the immune system to stop its attack. An earlier, large scale study was done to see if oral insulin could delay or prevent the development of Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results showed that for the entire study population, oral insulin did not delay or prevent Type 1 diabetes. However, an analysis that was done after the conclusion of the trial suggested a potential beneficial effect in a subgroup of participants. The participants who seemed to benefit from oral insulin had higher levels of insulin autoantibodies which are directed against insulin itself ( called mIAA). The Type 1 Diabetes TrialNet study group will further explore the potential role of oral insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also include a secondary group of individuals at different levels of risk than those in the primary cohort to gather information for future studies.
Interventions
- DRUG Placebo
- DRUG Oral Insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2007-02 |
| Est. Completion | 2017-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00419562
The ClinicalTrials.gov registry entry for NCT00419562 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 560 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 2 interventions - of which Placebo is the first listed.
NCT00419562 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00419562 about?
NCT00419562 is a clinical study titled "Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus". Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insuli...
What is the current status of trial NCT00419562?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 560 participants. The study started on 2007-02. Estimated completion is 2017-06.
What interventions are being tested in trial NCT00419562?
The interventions under investigation include: Placebo (DRUG), Oral Insulin (DRUG).
Who is sponsoring clinical trial NCT00419562?
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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