Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Public ClinicalTrials.gov record NCT00920582. 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 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (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 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.
Study identification
- NCT ID
- NCT00920582
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 254 participants
Conditions and interventions
Conditions
Interventions
- Teplizumab Herold Regimen Biological
- Placebo Drug
- Teplizumab 33.3% Herold Regimen Biological
- Teplizumab Curtailed Herold Regimen Biological
Biological · Drug
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
- Sep 2009 (Type not available)
- Primary completion
- Apr 2012 (Actual)
- Completion
- Jul 2012 (Actual)
- Last update posted
- Dec 20, 2023
2009 – 2012
United States locations
- U.S. sites
- 42
- U.S. states
- 26
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| NEA Clinic | Jonesboro | Arkansas | 72401 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72272 | — |
| Clinical Innovations Inc. Research Facility | Costa Mesa | California | 92626 | — |
| Axis Clinical Trials | Los Angeles | California | 90036 | — |
| Diabetes Associates Medical Group, Inc | Orange | California | 92868 | — |
| Clinical Innovations, Inc. | Riverside | California | 92506 | — |
| San Diego Clinical Trials | San Diego | California | 92120 | — |
| Ronald Chochinov Md Inc | Ventura | California | 93003 | — |
| 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 | — |
| John H Stoger Jr. Hospital of Cook County, Cook County Hospital | Chicago | Illinois | 60612 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| University of Iowa Children's Hospital | Iowa City | Iowa | 52242-1083 | — |
| Mid-America Diabetes Associates | Wichita | Kansas | 67211 | — |
| St. Agnes Hospital | Baltimore | Maryland | 21229 | — |
| Maryland Diabetes & Endocrine Associates | Rockville | Maryland | 20852 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Alzohaili Medical Consultants | Dearborn | Michigan | 48126 | — |
| Children's Hospitals and Clinics of Minnesota | Saint Paul | Minnesota | 55102 | — |
| University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology | Columbia | Missouri | 65212 | — |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Bassett Healthcare | Cooperstown | New York | 13326 | — |
| East Carolina University, Brody School of Medicine | Greenville | North Carolina | 27834 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| GHS Pediatric Endocrinology | Greenville | South Carolina | 29615 | — |
| AM Diabetes & Endocrinology Center | Bartlett | Tennessee | 38133 | — |
| University Diabetes & Endocrine Consultants | Chattanooga | Tennessee | 37403 | — |
| LeBonheur Children's Medical Center | Memphis | Tennessee | 38103 | — |
| Research Institute of Dallas | Dallas | Texas | 75231 | — |
| Southwest Clinical Trials | Houston | Texas | 77074 | — |
| Houston Center for Clinical Research | Houston | Texas | 77081 | — |
| Medical & Surgical Clinic of Irving | Irving | Texas | 75061 | — |
| InVisions Consultants, LLC | San Antonio | Texas | 78217 | — |
| Diabetes and Glandular Disease Research Associates, PA | San Antonio | Texas | 78229 | — |
| Endocrine Research Specialists | Ogden | Utah | 84403 | — |
| Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism | Richmond | Virginia | 23219 | — |
| University of Washington | Seattle | Washington | 98122 | — |
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 NCT00920582, 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 20, 2023 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00920582 live on ClinicalTrials.gov.