The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Public ClinicalTrials.gov record NCT00385697. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00385697
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 554 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 Years to 35 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2006 (Type not available)
- Primary completion
- Jun 2010 (Actual)
- Completion
- Aug 2011 (Actual)
- Last update posted
- Dec 5, 2023
2006 – 2011
United States locations
- U.S. sites
- 39
- U.S. states
- 28
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB School of Medicine | Birmingham | Alabama | 35294 | — |
| NEA Clinic | Jonesboro | Arkansas | 72401 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Diabetes Medical Center of California | Northridge | California | 91325 | — |
| UCSF Medical Center | San Francisco | California | 94143 | — |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | — |
| Yale University | New Haven | Connecticut | 06519 | — |
| Christiana Care Research Institute | Newark | Delaware | 19713 | — |
| Richard Hays, MD | Wellington | Florida | 33414 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | — |
| Humphrey Diabetes Center | Boise | Idaho | 87702 | — |
| Rocky Mountain Diabetes & Osteoporosis Center | Idaho Falls | Idaho | 83404 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| University of Iowa Children's Hospital | Iowa City | Iowa | 52242-1083 | — |
| Mid-America Diabetes Associates, PA | Wichita | Kansas | 67211 | — |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | — |
| St. Agnes Hospital | Baltimore | Maryland | 21229 | — |
| Maryland Diabetes & Endocrine Associates | Rockville | Maryland | 20852 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| Alzohaili Medical Consultants | Dearborn | Michigan | 48126 | — |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Creighton Diabetes Center | Omaha | Nebraska | 68131 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| University of Medicine & Dentistry of NJ | New Brunswick | New Jersey | 08901 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Schneider Children's Hospital | New Hyde Park | New York | 11040 | — |
| Joslin Diabetes Center | Syracuse | New York | 13214 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| St. Mary Medical Center | Langhorne | Pennsylvania | 19047 | — |
| Sumter Medical Specialists | Sumter | South Carolina | 29150 | — |
| University Diabetes & Endocrine Consultants | Chattanooga | Tennessee | 37403 | — |
| Methodist Healthcare | Memphis | Tennessee | 38104 | — |
| Research Institute of Dallas | Dallas | Texas | 75231 | — |
| Spectra Research Center | McAllen | Texas | 78503 | — |
| Diabetes and Glandular Disease Research | San Antonio | Texas | 78229 | — |
| Endocrine Research Specialists | Ogden | Utah | 84403 | — |
| Pacific Northwest Research Institute | Seattle | Washington | 98122 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 76 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00385697, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 5, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00385697 live on ClinicalTrials.gov.