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NCT00378508 · ClinicalTrials.gov registry record · Phase 2
Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT00378508: Completed Phase 2 study, sponsored by Yale University.
NCT00378508 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00378508, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
This is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration since diagnosis.
Primary Outcome
C-peptide secretory response was calculated as ln\[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1\] For presentation, the C-peptide data were converted to the AUC as pmol/ml. This is adjusted for baseline.
Interventions
- DRUG Placebo Arm
- DRUG mAb hOKT3gamma1(Ala-Ala), Teplizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2006-09 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT00378508 record still lists
NCT00378508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Arm is the first listed.
NCT00378508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00378508 about?
NCT00378508 is a clinical study titled "Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes". This is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration since diagnosis.
What is the current status of trial NCT00378508?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2006-09. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00378508?
The interventions under investigation include: Placebo Arm (DRUG), mAb hOKT3gamma1(Ala-Ala), Teplizumab (DRUG).
Who is sponsoring clinical trial NCT00378508?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00378508's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 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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