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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00920582
Other study ID # CP-MGA031-03
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 2009
Est. completion date July 2012

Study information

Verified date October 2023
Source MacroGenics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 254
Est. completion date July 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender All
Age group 8 Years to 35 Years
Eligibility Inclusion Criteria: 1. Subjects 8-35 years old 2. Body weight > 36 Kg 3. Diagnosis of diabetes mellitus according to the American Diabetes Association (ADA) criteria 4. Randomization on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes 5. Requires insulin for T1DM or has required insulin at some time between diagnosis and administration of study drug 6. Detectable fasting or stimulated C-peptide level (above the lower limit of the reportable range of the assay) at screening 7. 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). Exclusion Criteria: 1. Prior administration of a monoclonal antibody-within the 1 year before randomization 2. Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0 3. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial 4. Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study 5. 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 6. Current treatment with oral antidiabetic agents 7. Evidence of active or latent tuberculosis 8. 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 9. Any infectious mononucleosis-like illness within the 6 months before randomization

Study Design


Intervention

Biological:
Teplizumab Herold Regimen
Full dose of teplizumab IV for 14 days, repeated at Week 26
Drug:
Placebo
IV dosing daily for 14 days repeated at Week 26
Biological:
Teplizumab 33.3% Herold Regimen
One third full dose of teplizumab IV for 14 days, repeated at Week 26
Teplizumab Curtailed Herold Regimen
Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26

Locations

Country Name City State
Belgium Cliniques du Sud Luxembourg - Vivalia Arlon
Belgium Universitair Ziekenhuis Antwerpen Edegem Antwerp
Czechia I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice Brno
Czechia Centrum diabetologie, Institut klinicke a experimentalni mediciny Praha
Czechia Klinika deti a dorostu FN Kralovske Vinohrady Praha
Czechia Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole Praha
Czechia Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z. Usti nad Labem
Finland Kuopio University Hospital Kuopio
Finland Central Hospital of Mikkeli Mikkeli
Finland Oulu University Hospital Oulu
France CHU de Besançon Besançon
France CHU de Brest Hôpital de la Cavale Blanche Brest
France Centre Hospitalier Sud Francilien Corbeil-Essonnes
France CHU de Bordeaux Pessac
France CHU de Reims Reims
France Hôpitaux Universitaires de Strasbourg Hôpital Civil Strasbourg
Germany Diabetes-Klinik Bad Nauheim GmbH Bad Nauheim
Germany Herz und Diabeteszentrum Nordrhein-Westfallen Bad Oeynhausen
Germany Charite, Campus Benjamin Franklin Berlin
Germany Universitätsklinikum Düsseldorf Düsseldorf
Germany Universitatsklinik Giessen Giessen
Germany Asklepios Westklinikum Hamburg Hamburg
Germany Kinderkrankenhaus auf der Bult Hannover
Germany Universitatsklinikum Heidelberg Heidelberg
India DHL Research Centre Ahmedabad Gujarat
India Bangalore Diabetes Centre Bangalore Karnataka
India Kalinga Hospital Limited Bhubaneswar Orissa
India Hormone Care & Research Center Ghaziabad Uttar Pradesh
India Medwin Hospitals Hyderabad Andhra Pradesh
India Fortis Escorts Hospital Jaipur Rajasthan
India Apollo Glenagles Hospital Kolkata West Bengal
India B. P. Poddar Hospital & Medical Research Limited Kolkata West Bengal
India Dayanand Medical College and Hospital Ludhiana Punjab
India Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd. Madhya Pradesh
India Gandhi's Research Institute Nagpur Maharashtra
India Maulana Azad Medical College and Associated Hospitals New Delhi Delhi
India Grant Medical Foundation Pune Maharashtra
India KEM Hospital Research Center Pune Maharashtra
India Health & Research Centre Trivandrum Kerala
India King George Hospital Visakhapatnam Andhra Pradesh
Israel Hillel Yaffe Medical Center Hadera
Israel Mayer Children's Hospital of Haifa Haifa
Israel The E. Wolfson Medical Center Holon
Israel Schneider Children's Medical Petach-Tikva
Israel The Safra Children's Hospital, The Chaim Sheba Medical Center Ramat-Gan
Italy Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena, Modena
Italy U.O. di Malattie del Metabolismo Pisa
Italy U.O. di Malattie Metaboliche e Diabetologia Pisa
Mexico Medical Care & Research Merida Yucatan
Mexico Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C. Mexico, Distrito Federal
Mexico Hospital y Clinica OCA / Monterrey International Research Center Monterrey Nuevo León
Netherlands Stichting Diabeter Rotterdam
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok
Poland Uniwersyteckie Centrum Kliniczne Gdansk
Poland Wojewódzki Specjalistyczny Szpital Dzieciecy Kielce
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4 Lódz
Poland Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia Warszawa
Poland Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu Wroclaw
Romania S.C. Minimed S.R.L. Bacau
Romania Institutul National De Diabet, Nutritie si Boli Metabolice Bucuresti
Romania Spitalul Judetean de Urgenta Satu Mare Satu-Mare
Spain Hospital Universitario Principe de Asturias Alcala de Henares
Spain Hospital Dr. Josep Trueta Girona
Ukraine Donetsk Regional Children Clinical Hospital Donetsk
Ukraine Ivano-Frankivsk Regional Clinical Hospital Ivano-Frankivsk
Ukraine Ivano-Frankivsk State Regional Pediatric Clinical Hospital Ivano-Frankivsk
Ukraine Kharkiv Regional Clinical Children Hospital, Department of Endocrinology Kharkiv
Ukraine Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine Kyiv
Ukraine Ukrainian Children Specialized Clinical Hospital Kyiv
Ukraine Regional Clinical Endocrinology Dispensary of MoH Ukraine Vinnitsa
United Kingdom University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology, Bristol
United Kingdom Aintree University Hospitals NHS Foundation Trust Liverpool
United Kingdom Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology London
United Kingdom Queens Medical Centre, Diabetes and Endocrinology Unit Nottingham
United Kingdom George Eliot Hospital NHS Trust Nuneaton Warwickshire
United Kingdom Sheffield Children's Hospital NHS Foundation Trust Sheffield
United States Albany Medical College Albany New York
United States Atlanta Diabetes Associates Atlanta Georgia
United States St. Agnes Hospital Baltimore Maryland
United States AM Diabetes & Endocrinology Center Bartlett Tennessee
United States University of Alabama at Birmingham Birmingham Alabama
United States Massachusetts General Hospital Boston Massachusetts
United States University Diabetes & Endocrine Consultants Chattanooga Tennessee
United States John H Stoger Jr. Hospital of Cook County, Cook County Hospital Chicago Illinois
United States University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology Columbia Missouri
United States Bassett Healthcare Cooperstown New York
United States Clinical Innovations Inc. Research Facility Costa Mesa California
United States Research Institute of Dallas Dallas Texas
United States Alzohaili Medical Consultants Dearborn Michigan
United States East Carolina University, Brody School of Medicine Greenville North Carolina
United States GHS Pediatric Endocrinology Greenville South Carolina
United States Houston Center for Clinical Research Houston Texas
United States Southwest Clinical Trials Houston Texas
United States Indiana University School of Medicine Indianapolis Indiana
United States University of Iowa Children's Hospital Iowa City Iowa
United States Medical & Surgical Clinic of Irving Irving Texas
United States NEA Clinic Jonesboro Arkansas
United States The Children's Mercy Hospital Kansas City Missouri
United States Arkansas Children's Hospital Little Rock Arkansas
United States Saint Barnabas Medical Center Livingston New Jersey
United States Axis Clinical Trials Los Angeles California
United States LeBonheur Children's Medical Center Memphis Tennessee
United States Yale University New Haven Connecticut
United States Christiana Care Research Institute Newark Delaware
United States Endocrine Research Specialists Ogden Utah
United States Diabetes Associates Medical Group, Inc Orange California
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism Richmond Virginia
United States Clinical Innovations, Inc. Riverside California
United States Maryland Diabetes & Endocrine Associates Rockville Maryland
United States Children's Hospitals and Clinics of Minnesota Saint Paul Minnesota
United States Diabetes and Glandular Disease Research Associates, PA San Antonio Texas
United States InVisions Consultants, LLC San Antonio Texas
United States San Diego Clinical Trials San Diego California
United States University of Washington Seattle Washington
United States Ronald Chochinov Md Inc Ventura California
United States Richard Hays, MD Wellington Florida
United States Mid-America Diabetes Associates Wichita Kansas

Sponsors (2)

Lead Sponsor Collaborator
MacroGenics Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Finland,  France,  Germany,  India,  Israel,  Italy,  Mexico,  Netherlands,  Poland,  Romania,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Mean Change From Baseline in HbA1c Between Teplizumab and Placebo 52 weeks after randomization
Secondary The Change in Beta-cell Function as Measured by C-peptide Secretory Response Following a Mixed Meal 52 weeks after randomization
Secondary The Change in Beta-cell Function as Measured by C-peptide Secretory Response Following a Mixed Meal 104 weeks after randomization
Secondary Mean Number of Total, Major, Minor and Nocturnal Hypoglycemia Events Number of hypoglycemic events by type per participant Throughout the study up to 2 years
Secondary Mean Number of Daily Insulin Injections 52 weeks after randomization
Secondary 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
Secondary The Proportion of Subjects Who Have Both a Total Daily Insulin Dose < 0.5 U/Kg/Day and Hemoglobin A1c (HbA1c) Level < 7.0% 52 weeks after randomization
Secondary The Mean HbA1c Change From Baseline 104 weeks after randomization
Secondary Number of Participants With Adverse Events throughout the study, up to 104 weeks
Secondary Number of Participants With Serious Adverse Events throughout the study, up to 104 weeks
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