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Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
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
1 other identifier
interventional
254
16 countries
118
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2009
Typical duration for phase_3
118 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
December 20, 2023
CompletedDecember 20, 2023
October 1, 2023
2.6 years
June 12, 2009
March 8, 2023
November 30, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of Subjects With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.
52 weeks after randomization
Mean Change From Baseline in HbA1c Between Teplizumab and Placebo
52 weeks after randomization
Secondary Outcomes (9)
The Change in Beta-cell Function as Measured by C-peptide Secretory Response Following a Mixed Meal
52 weeks after randomization
The Change in Beta-cell Function as Measured by C-peptide Secretory Response Following a Mixed Meal
104 weeks after randomization
Mean Number of Total, Major, Minor and Nocturnal Hypoglycemia Events
Throughout the study up to 2 years
Mean Number of Daily Insulin Injections
52 weeks after randomization
Number of Subjects With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.
104 weeks after randomization
- +4 more secondary outcomes
Study Arms (4)
Herold Regimen
EXPERIMENTAL14-day cycle of teplizumab consisting of daily IV doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, and 413 µg/m2 on Study Days 1-4, respectively, and one dose of 826 µg/m2 on each of Study Days 5-14. Repeat at Week 26
33.3% Herold Regimen
EXPERIMENTALSubjects received a 14-day cycle of teplizumab consisting of daily IV doses of 17 µg/m2, 34 µg/m2, 68 µg/m2, and 136 µg/m2 on Study Days 1-4, respectively, and one dose of 273 µg/m2 on each of Study Days 5-14. Repeat at Week 26
Curtailed Herold Regimen
EXPERIMENTALSubjects received a 6 day cycle of teplizumab consisting of daily IV doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, and 413 µg/m2 on Study Days 1-4, respectively, and one dose of 826 µg/m2 on each of Study Days 5-6, followed by 8 days of IV placebo (Study Days 7-14). Repeat at Week 26
Placebo
PLACEBO COMPARATOR14-day cycle of placebo consisting of daily IV doses. Repeat at Week 26
Interventions
Full dose of teplizumab IV for 14 days, repeated at Week 26
One third full dose of teplizumab IV for 14 days, repeated at Week 26
Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26
Eligibility Criteria
You may qualify if:
- Subjects 8-35 years old
- Body weight \> 36 Kg
- Diagnosis of diabetes mellitus according to the American Diabetes Association (ADA) criteria
- Randomization on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes
- Requires insulin for T1DM or has required insulin at some time between diagnosis and administration of study drug
- Detectable fasting or stimulated C-peptide level (above the lower limit of the reportable range of the assay) at screening
- Diagnosis of T1DM as evidenced by one positive result on testing for any of the following antibodies at screening:
- Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2),
- Glutamic acid decarboxylase (GAD) autoantibodies, or
- Insulin autoantibodies (in subjects on insulin for more than 2 weeks, ICA512/IA-2 or GAD must be positive).
You may not qualify if:
- Prior administration of a monoclonal antibody-within the 1 year before randomization
- Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0
- Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
- Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study
- Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion
- Current treatment with oral antidiabetic agents
- Evidence of active or latent tuberculosis
- Vaccination with a live virus or organism within the 8 weeks before randomization continuing through Week 52 of the study.
- Influenza vaccination with a killed virus, including booster vaccinations, within 4 weeks before or after each dosing cycle.
- Vaccination with other antigens or killed organisms within 8 weeks before or after each dosing cycle
- Any infectious mononucleosis-like illness within the 6 months before randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MacroGenicslead
- Eli Lilly and Companycollaborator
Study Sites (118)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
NEA Clinic
Jonesboro, Arkansas, 72401, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72272, United States
Clinical Innovations Inc. Research Facility
Costa Mesa, California, 92626, United States
Axis Clinical Trials
Los Angeles, California, 90036, United States
Diabetes Associates Medical Group, Inc
Orange, California, 92868, United States
Clinical Innovations, Inc.
Riverside, California, 92506, United States
San Diego Clinical Trials
San Diego, California, 92120, United States
Ronald Chochinov Md Inc
Ventura, California, 93003, United States
Yale University
New Haven, Connecticut, 06519, United States
Christiana Care Research Institute
Newark, Delaware, 19713, United States
Richard Hays, MD
Wellington, Florida, 33414, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30309, United States
John H Stoger Jr. Hospital of Cook County, Cook County Hospital
Chicago, Illinois, 60612, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Iowa Children's Hospital
Iowa City, Iowa, 52242-1083, United States
Mid-America Diabetes Associates
Wichita, Kansas, 67211, United States
St. Agnes Hospital
Baltimore, Maryland, 21229, United States
Maryland Diabetes & Endocrine Associates
Rockville, Maryland, 20852, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Alzohaili Medical Consultants
Dearborn, Michigan, 48126, United States
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102, United States
University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology
Columbia, Missouri, 65212, United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Albany Medical College
Albany, New York, 12208, United States
Bassett Healthcare
Cooperstown, New York, 13326, United States
East Carolina University, Brody School of Medicine
Greenville, North Carolina, 27834, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
GHS Pediatric Endocrinology
Greenville, South Carolina, 29615, United States
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, 38133, United States
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37403, United States
LeBonheur Children's Medical Center
Memphis, Tennessee, 38103, United States
Research Institute of Dallas
Dallas, Texas, 75231, United States
Southwest Clinical Trials
Houston, Texas, 77074, United States
Houston Center for Clinical Research
Houston, Texas, 77081, United States
Medical & Surgical Clinic of Irving
Irving, Texas, 75061, United States
InVisions Consultants, LLC
San Antonio, Texas, 78217, United States
Diabetes and Glandular Disease Research Associates, PA
San Antonio, Texas, 78229, United States
Endocrine Research Specialists
Ogden, Utah, 84403, United States
Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism
Richmond, Virginia, 23219, United States
University of Washington
Seattle, Washington, 98122, United States
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, 2650, Belgium
Cliniques du Sud Luxembourg - Vivalia
Arlon, 6700, Belgium
I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice
Brno, 62500, Czechia
Klinika deti a dorostu FN Kralovske Vinohrady
Prague, 10034, Czechia
Centrum diabetologie, Institut klinicke a experimentalni mediciny
Prague, 14021, Czechia
Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole
Prague, 15006, Czechia
Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, 40113, Czechia
Kuopio University Hospital
Kuopio, 70210, Finland
Central Hospital of Mikkeli
Mikkeli, 50100, Finland
Oulu University Hospital
Oulu, 90029, Finland
CHU de Besançon
Besançon, 25030, France
CHU de Brest Hôpital de la Cavale Blanche
Brest, 29609, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106, France
CHU de Bordeaux
Pessac, 33604, France
CHU de Reims
Reims, 51092, France
Hôpitaux Universitaires de Strasbourg Hôpital Civil
Strasbourg, 67091, France
Diabetes-Klinik Bad Nauheim GmbH
Bad Nauheim, 61231, Germany
Herz und Diabeteszentrum Nordrhein-Westfallen
Bad Oeynhausen, 32545, Germany
Charite, Campus Benjamin Franklin
Berlin, 12200, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 20225, Germany
Universitatsklinik Giessen
Giessen, 35392, Germany
Asklepios Westklinikum Hamburg
Hamburg, 22559, Germany
Kinderkrankenhaus auf der Bult
Hanover, 30173, Germany
Universitatsklinikum Heidelberg
Heidelberg, 69120, Germany
Medwin Hospitals
Hyderabad, Andhra Pradesh, 500001, India
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002, India
DHL Research Centre
Ahmedabad, Gujarat, 380015, India
Bangalore Diabetes Centre
Bangalore, Karnataka, 560043, India
Health & Research Centre
Trivandrum, Kerala, 695011, India
Gandhi's Research Institute
Nagpur, Maharashtra, 440010, India
Grant Medical Foundation
Pune, Maharashtra, 411001, India
KEM Hospital Research Center
Pune, Maharashtra, 411011, India
Maulana Azad Medical College and Associated Hospitals
New Delhi, National Capital Territory of Delhi, 110002, India
Kalinga Hospital Limited
Bhubaneswar, Odisha, 751023, India
Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd.
Madhya, Pradesh, 452001, India
Dayanand Medical College and Hospital
Ludhiana, Punjab, 141001, India
Fortis Escorts Hospital
Jaipur, Rajasthan, 302017, India
Hormone Care & Research Center
Ghaziabad, Uttar Pradesh, 201002, India
B. P. Poddar Hospital & Medical Research Limited
Kolkata, West Bengal, 700053, India
Apollo Glenagles Hospital
Kolkata, West Bengal, 700054, India
Hillel Yaffe Medical Center
Hadera, 38100, Israel
Mayer Children's Hospital of Haifa
Haifa, 31096, Israel
The E. Wolfson Medical Center
Holon, 58100, Israel
Schneider Children's Medical
Petah Tikva, 49202, Israel
The Safra Children's Hospital, The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena,
Modena, 41124, Italy
U.O. di Malattie del Metabolismo
Pisa, 16132, Italy
U.O. di Malattie Metaboliche e Diabetologia
Pisa, 56124, Italy
Hospital y Clinica OCA / Monterrey International Research Center
Monterrey, Nuevo León, 64000, Mexico
Medical Care & Research
Mérida, Yucatán, 97070, Mexico
Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.
Mexico City, 11650, Mexico
Stichting Diabeter
Rotterdam, 3011 TG, Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Wojewódzki Specjalistyczny Szpital Dzieciecy
Kielce, 25-734, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4
Lodz, 91-738, Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia
Warsaw, 01-184, Poland
Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu
Wroclaw, 50-376, Poland
S.C. Minimed S.R.L.
Bacau, 600164, Romania
Institutul National De Diabet, Nutritie si Boli Metabolice
Bucharest, 020045, Romania
Spitalul Judetean de Urgenta Satu Mare
Satu Mare, 440055, Romania
Hospital Universitario Principe de Asturias
Alcalá de Henares, 28805, Spain
Hospital Dr. Josep Trueta
Girona, 17007, Spain
Donetsk Regional Children Clinical Hospital
Donetsk, 83052, Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, 76008, Ukraine
Ivano-Frankivsk State Regional Pediatric Clinical Hospital
Ivano-Frankivsk, 76014, Ukraine
Kharkiv Regional Clinical Children Hospital, Department of Endocrinology
Kharkiv, 61093, Ukraine
Ukrainian Children Specialized Clinical Hospital
Kyiv, 01135, Ukraine
Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine
Kyiv, 04114, Ukraine
Regional Clinical Endocrinology Dispensary of MoH Ukraine
Vinnitsa, 21010, Ukraine
George Eliot Hospital NHS Trust
Nuneaton, Warwickshire, CV10 7DJ, United Kingdom
University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology,
Bristol, BS1 3NY, United Kingdom
Aintree University Hospitals NHS Foundation Trust
Liverpool, L9 7AL, United Kingdom
Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology
London, SE1 9RT, United Kingdom
Queens Medical Centre, Diabetes and Endocrinology Unit
Nottingham, NG7 2UH, United Kingdom
Sheffield Children's Hospital NHS Foundation Trust
Sheffield, S10 2IH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sharon Rowland
- Organization
- Provention Bio, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 15, 2009
Study Start
September 1, 2009
Primary Completion
April 1, 2012
Study Completion
July 1, 2012
Last Updated
December 20, 2023
Results First Posted
December 20, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share