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NCT00920582 · ClinicalTrials.gov registry record · Phase 3
Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
A Phase 3 study, sponsored by MacroGenics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 254
- Enrollment target
NCT00920582: Clinical Trial Phase 3 study, sponsored by MacroGenics.
NCT00920582 is a Phase 3 study that was terminated before completion, run by MacroGenics. The registered enrollment target is 254 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00920582, a Phase 3 study, was terminated before completion, sponsored by MacroGenics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 254 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.
Interventions
- DRUG Placebo
- BIOLOGICAL Teplizumab Herold Regimen
- BIOLOGICAL Teplizumab 33.3% Herold Regimen
- BIOLOGICAL Teplizumab Curtailed Herold Regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
Why NCT00920582 stopped before completion
NCT00920582 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00920582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00920582 about?
NCT00920582 is a clinical study titled "Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus". The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.
What is the current status of trial NCT00920582?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 254 participants. The study started on 2009-09. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00920582?
The interventions under investigation include: Placebo (DRUG), Teplizumab Herold Regimen (BIOLOGICAL), Teplizumab 33.3% Herold Regimen (BIOLOGICAL), Teplizumab Curtailed Herold Regimen (BIOLOGICAL).
Who is sponsoring clinical trial NCT00920582?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00920582's enrollment target sits among peer trials
254 1245th of 2000 higher than 755 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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