Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Public ClinicalTrials.gov record NCT00419562. 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.
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.
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.
Study identification
- NCT ID
- NCT00419562
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 560 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2007
- Primary completion
- Nov 30, 2016
- Completion
- May 31, 2017
- Last update posted
- May 6, 2020
2007 – 2017
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California-San Francisco | San Francisco | California | 94143 | — |
| Stanford University | Stanford | California | 94305 | — |
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80010 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| University of Florida | Gainesville | Florida | 32610-0296 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Indiana University-Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Columbia University | New York | New York | 10032 | — |
| Childrens Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Vanderbilt Eskind Diabetes Clinic | Nashville | Tennessee | 37232-8160 | — |
| University of Texas | Dallas | Texas | 75235-8858 | — |
| Benaroya Research Institute | 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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00419562, 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 May 6, 2020 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00419562 live on ClinicalTrials.gov.