254
Participants
Start Date
September 30, 2009
Primary Completion Date
April 30, 2012
Study Completion Date
July 31, 2012
Teplizumab Herold Regimen
Full dose of teplizumab IV for 14 days, repeated at Week 26
Placebo
IV dosing daily for 14 days repeated at Week 26
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
Universitair Ziekenhuis Antwerpen, Edegem
Cliniques du Sud Luxembourg - Vivalia, Arlon
Klinika deti a dorostu FN Kralovske Vinohrady, Prague
Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C., Mexico City
Charite, Campus Benjamin Franklin, Berlin
Albany Medical College, Albany
Bassett Healthcare, Cooperstown
Centrum diabetologie, Institut klinicke a experimentalni mediciny, Prague
Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole, Prague
U.O. di Malattie del Metabolismo, Pisa
Hospital Dr. Josep Trueta, Girona
Children's Hospital of Philadelphia, Philadelphia
Christiana Care Research Institute, Newark
Universitätsklinikum Düsseldorf, Düsseldorf
Maryland Diabetes & Endocrine Associates, Rockville
Regional Clinical Endocrinology Dispensary of MoH Ukraine, Vinnitsa
St. Agnes Hospital, Baltimore
Asklepios Westklinikum Hamburg, Hamburg
Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism, Richmond
CHU de Besançon, Besançon
East Carolina University, Brody School of Medicine, Greenville
Hospital Universitario Principe de Asturias, Alcalá de Henares
CHU de Brest Hôpital de la Cavale Blanche, Brest
GHS Pediatric Endocrinology, Greenville
Kinderkrankenhaus auf der Bult, Hanover
Atlanta Diabetes Associates, Atlanta
Mayer Children's Hospital of Haifa, Haifa
Herz und Diabeteszentrum Nordrhein-Westfallen, Bad Oeynhausen
Richard Hays, MD, Wellington
CHU de Bordeaux, Pessac
University of Alabama at Birmingham, Birmingham
Universitatsklinik Giessen, Giessen
University Diabetes & Endocrine Consultants, Chattanooga
Hillel Yaffe Medical Center, Hadera
LeBonheur Children's Medical Center, Memphis
AM Diabetes & Endocrinology Center, Bartlett
Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z., Ústí nad Labem
Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena,, Modena
Indiana University School of Medicine, Indianapolis
Alzohaili Medical Consultants, Dearborn
Schneider Children's Medical, Petah Tikva
Central Hospital of Mikkeli, Mikkeli
CHU de Reims, Reims
The Safra Children's Hospital, The Chaim Sheba Medical Center, Ramat Gan
Children's Hospitals and Clinics of Minnesota, Saint Paul
U.O. di Malattie Metaboliche e Diabetologia, Pisa
The E. Wolfson Medical Center, Holon
John H Stoger Jr. Hospital of Cook County, Cook County Hospital, Chicago
Kharkiv Regional Clinical Children Hospital, Department of Endocrinology, Kharkiv
Diabetes-Klinik Bad Nauheim GmbH, Bad Nauheim
I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice, Brno
Hospital y Clinica OCA / Monterrey International Research Center, Monterrey
The Children's Mercy Hospital, Kansas City
University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology, Columbia
Hôpitaux Universitaires de Strasbourg Hôpital Civil, Strasbourg
Mid-America Diabetes Associates, Wichita
Universitatsklinikum Heidelberg, Heidelberg
Kuopio University Hospital, Kuopio
Arkansas Children's Hospital, Little Rock
NEA Clinic, Jonesboro
Medical & Surgical Clinic of Irving, Irving
Research Institute of Dallas, Dallas
Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk
Ivano-Frankivsk State Regional Pediatric Clinical Hospital, Ivano-Frankivsk
Southwest Clinical Trials, Houston
Houston Center for Clinical Research, Houston
InVisions Consultants, LLC, San Antonio
Diabetes and Glandular Disease Research Associates, PA, San Antonio
Donetsk Regional Children Clinical Hospital, Donetsk
Endocrine Research Specialists, Ogden
Oulu University Hospital, Oulu
Axis Clinical Trials, Los Angeles
Centre Hospitalier Sud Francilien, Corbeil-Essonnes
San Diego Clinical Trials, San Diego
Clinical Innovations, Inc., Riverside
Clinical Innovations Inc. Research Facility, Costa Mesa
Diabetes Associates Medical Group, Inc, Orange
Ronald Chochinov Md Inc, Ventura
Medical Care & Research, Mérida
University of Washington, Seattle
Maulana Azad Medical College and Associated Hospitals, New Delhi
Dayanand Medical College and Hospital, Ludhiana
Hormone Care & Research Center, Ghaziabad
Fortis Escorts Hospital, Jaipur
DHL Research Centre, Ahmedabad
Grant Medical Foundation, Pune
KEM Hospital Research Center, Pune
Gandhi's Research Institute, Nagpur
Spitalul Judetean de Urgenta Satu Mare, Satu Mare
Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd., Madhya
Medwin Hospitals, Hyderabad
King George Hospital, Visakhapatnam
Bangalore Diabetes Centre, Bangalore
S.C. Minimed S.R.L., Bacau
Health & Research Centre, Trivandrum
B. P. Poddar Hospital & Medical Research Limited, Kolkata
Apollo Glenagles Hospital, Kolkata
Kalinga Hospital Limited, Bhubaneswar
Yale University, New Haven
University of Iowa Children's Hospital, Iowa City
Massachusetts General Hospital, Boston
Saint Barnabas Medical Center, Livingston
Stichting Diabeter, Rotterdam
Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok
Uniwersyteckie Centrum Kliniczne, Gdansk
Wojewódzki Specjalistyczny Szpital Dzieciecy, Kielce
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4, Lodz
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia, Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu, Wroclaw
Institutul National De Diabet, Nutritie si Boli Metabolice, Bucharest
Ukrainian Children Specialized Clinical Hospital, Kyiv
Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine, Kyiv
George Eliot Hospital NHS Trust, Nuneaton
University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology,, Bristol
Aintree University Hospitals NHS Foundation Trust, Liverpool
Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology, London
Queens Medical Centre, Diabetes and Endocrinology Unit, Nottingham
Sheffield Children's Hospital NHS Foundation Trust, Sheffield
Lead Sponsor
Eli Lilly and Company
INDUSTRY
MacroGenics
INDUSTRY