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NCT02580877 · ClinicalTrials.gov registry record · Phase 2
Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT02580877: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02580877 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02580877, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study Summary
The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).
Primary Outcome
Change in T-lymphocyte (GAD65) biomarker of beta cell specific immune response
Interventions
- DRUG 67.5 mg oral insulin crystals daily
- DRUG 500mg oral insulin crystals every other week
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-03 |
| Phase | Phase 2 |
What the finished NCT02580877 record still lists
NCT02580877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which 67.5 mg oral insulin crystals daily is the first listed.
NCT02580877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02580877 about?
NCT02580877 is a clinical study titled "Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)". The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).
What is the current status of trial NCT02580877?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2016-01. Estimated completion is 2018-03.
What interventions are being tested in trial NCT02580877?
The interventions under investigation include: 67.5 mg oral insulin crystals daily (DRUG), 500mg oral insulin crystals every other week (DRUG).
Who is sponsoring clinical trial NCT02580877?
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 NCT02580877's enrollment target sits among peer trials
92 767th of 2000 higher than 1,230 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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