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NCT00129259 · ClinicalTrials.gov registry record · Phase 2
Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
NCT00129259: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00129259 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00129259, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
Study Summary
Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 \[Ala-Ala\],teplizumab, MGA031) is a humanized antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1 diabetes.
Primary Outcome
C-peptide AUC is computed using the trapezoidal rule and dividing by the interval of time from the 4 hour Mixed Meal Tolerance Test (MMTT) where assessments are taken every 30 minutes after initial assessments 15 minutes apart. A higher C-peptide AUC is desirable as detectable C-peptide is a marker for the ability of the pancreas to produce insulin in response to a MMTT. The baseline data was used to adjust for the C-peptide AUC primary endpoint at 24 months. Missing month 24 C-peptide results a
Interventions
- BIOLOGICAL Anti-CD3 mAb
- OTHER Diabetes Standard of Care Treatment
- DIETARY_SUPPLEMENT Iron supplementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2005-09 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
What the finished NCT00129259 record still lists
NCT00129259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 3 interventions - of which Anti-CD3 mAb is the first listed.
NCT00129259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00129259 about?
NCT00129259 is a clinical study titled "Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes". Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 \[Ala-Ala\],teplizumab, MGA031) is a humanized antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1 diabetes.
What is the current status of trial NCT00129259?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2005-09. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00129259?
The interventions under investigation include: Anti-CD3 mAb (BIOLOGICAL), Diabetes Standard of Care Treatment (OTHER), Iron supplementation (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00129259?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00129259's enrollment target sits among peer trials
83 828th of 2000 higher than 1,171 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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