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NCT00385697 · ClinicalTrials.gov registry record · Phase 2
The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
A Phase 2 study of Type 1 Diabetes Mellitus, sponsored by MacroGenics.
- Completed
- Registry status
- Phase 2
- Development phase
- 554
- Enrollment target
- 20
- Study locations
NCT00385697: Completed Phase 2 study of Type 1 Diabetes Mellitus, sponsored by MacroGenics.
NCT00385697 is a Phase 2 study of Type 1 Diabetes Mellitus that has completed, run by MacroGenics. The registered enrollment target is 554 participants, above the 167-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (232% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00385697, a Phase 2 study of Type 1 Diabetes Mellitus, has completed, sponsored by MacroGenics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 554 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to insulin and other standard of care treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels. Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics, Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.
Primary Outcome
This is a composite endpoint is based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5% at 52 weeks after randomization.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Teplizumab
Study Locations (20)
Arkansas
- NEA Clinic - Jonesboro
- Arkansas Children's Hospital - Little Rock
California
- Diabetes Medical Center of California - Northridge
- UCSF Medical Center - San Francisco
Idaho
- Humphrey Diabetes Center - Boise
- Rocky Mountain Diabetes & Osteoporosis Center - Idaho Falls
Maryland
- St. Agnes Hospital - Baltimore
- Maryland Diabetes & Endocrine Associates - Rockville
Massachusetts
- Massachusetts General Hospital - Boston
- Baystate Medical Center - Springfield
Alabama
- UAB School of Medicine - Birmingham
Colorado
- University of Colorado Health Sciences Center - Aurora
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 554 participants |
| Start Date | 2006-10 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT00385697 record still lists
NCT00385697 is an interventional study that assigns participants to a tested intervention. The registered 554 participants enrollment target is mid-sized for trials with a published cap, above the 167-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (232% higher).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00385697 names 20 study sites across 15 states, led by Arkansas, California, Idaho.
Frequently Asked Questions
What is clinical trial NCT00385697 about?
NCT00385697 is a clinical study titled "The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus". The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered a...
What is the current status of trial NCT00385697?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 554 participants. The study started on 2006-10. Estimated completion is 2011-08.
What conditions does trial NCT00385697 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT00385697?
The interventions under investigation include: Placebo (DRUG), Teplizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00385697?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00385697 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00385697's enrollment target sits among peer trials
554 6th of 112 higher than 107 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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.
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