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NCT00965458 · ClinicalTrials.gov registry record · Phase 2
Inducing Remission in Type 1 Diabetes With Alefacept
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00965458: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00965458 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00965458, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this trial is to test whether a drug called alefacept will slow or halt destruction of the beta cells in the pancreas. If the destruction of the beta cells is stopped, the patients might be able to produce insulin on their own longer, which could stop or slow the progression of their type 1 diabetes. This is a multi-center prospective, placebo-controlled, double-blind and randomized trial to investigate the ability of alefacept to protect residual beta cells from ongoing autoimmune destruction in adolescents and young adults with newly diagnosed Type 1 Diabetes Mellitus (T1DM).
Primary Outcome
C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are pr
Interventions
- DRUG Placebo
- BIOLOGICAL Alefacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
Why NCT00965458 stopped before completion
NCT00965458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00965458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00965458 about?
NCT00965458 is a clinical study titled "Inducing Remission in Type 1 Diabetes With Alefacept". The purpose of this trial is to test whether a drug called alefacept will slow or halt destruction of the beta cells in the pancreas. If the destruction of the beta cells is stopped, the patients might be able to produce insulin on their own longer, which could stop or slow the progression of their ...
What is the current status of trial NCT00965458?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2011-03. Estimated completion is 2014-04.
What interventions are being tested in trial NCT00965458?
The interventions under investigation include: Placebo (DRUG), Alefacept (BIOLOGICAL).
Who is sponsoring clinical trial NCT00965458?
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 NCT00965458's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 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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