Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

PHASE3TerminatedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

April 30, 2012

Study Completion Date

July 31, 2012

Conditions
Type 1 Diabetes Mellitus
Interventions
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

BIOLOGICAL

Teplizumab Curtailed Herold Regimen

Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26

Trial Locations (118)

2650

Universitair Ziekenhuis Antwerpen, Edegem

6700

Cliniques du Sud Luxembourg - Vivalia, Arlon

10034

Klinika deti a dorostu FN Kralovske Vinohrady, Prague

11650

Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C., Mexico City

12200

Charite, Campus Benjamin Franklin, Berlin

12208

Albany Medical College, Albany

13326

Bassett Healthcare, Cooperstown

14021

Centrum diabetologie, Institut klinicke a experimentalni mediciny, Prague

15006

Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole, Prague

16132

U.O. di Malattie del Metabolismo, Pisa

17007

Hospital Dr. Josep Trueta, Girona

19104

Children's Hospital of Philadelphia, Philadelphia

19713

Christiana Care Research Institute, Newark

20225

Universitätsklinikum Düsseldorf, Düsseldorf

20852

Maryland Diabetes & Endocrine Associates, Rockville

21010

Regional Clinical Endocrinology Dispensary of MoH Ukraine, Vinnitsa

21229

St. Agnes Hospital, Baltimore

22559

Asklepios Westklinikum Hamburg, Hamburg

23219

Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism, Richmond

25030

CHU de Besançon, Besançon

27834

East Carolina University, Brody School of Medicine, Greenville

28805

Hospital Universitario Principe de Asturias, Alcalá de Henares

29609

CHU de Brest Hôpital de la Cavale Blanche, Brest

29615

GHS Pediatric Endocrinology, Greenville

30173

Kinderkrankenhaus auf der Bult, Hanover

30309

Atlanta Diabetes Associates, Atlanta

31096

Mayer Children's Hospital of Haifa, Haifa

32545

Herz und Diabeteszentrum Nordrhein-Westfallen, Bad Oeynhausen

33414

Richard Hays, MD, Wellington

33604

CHU de Bordeaux, Pessac

35233

University of Alabama at Birmingham, Birmingham

35392

Universitatsklinik Giessen, Giessen

37403

University Diabetes & Endocrine Consultants, Chattanooga

38100

Hillel Yaffe Medical Center, Hadera

38103

LeBonheur Children's Medical Center, Memphis

38133

AM Diabetes & Endocrinology Center, Bartlett

40113

Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z., Ústí nad Labem

41124

Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena,, Modena

46202

Indiana University School of Medicine, Indianapolis

48126

Alzohaili Medical Consultants, Dearborn

49202

Schneider Children's Medical, Petah Tikva

50100

Central Hospital of Mikkeli, Mikkeli

51092

CHU de Reims, Reims

52621

The Safra Children's Hospital, The Chaim Sheba Medical Center, Ramat Gan

55102

Children's Hospitals and Clinics of Minnesota, Saint Paul

56124

U.O. di Malattie Metaboliche e Diabetologia, Pisa

58100

The E. Wolfson Medical Center, Holon

60612

John H Stoger Jr. Hospital of Cook County, Cook County Hospital, Chicago

61093

Kharkiv Regional Clinical Children Hospital, Department of Endocrinology, Kharkiv

61231

Diabetes-Klinik Bad Nauheim GmbH, Bad Nauheim

62500

I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice, Brno

64000

Hospital y Clinica OCA / Monterrey International Research Center, Monterrey

64108

The Children's Mercy Hospital, Kansas City

65212

University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology, Columbia

67091

Hôpitaux Universitaires de Strasbourg Hôpital Civil, Strasbourg

67211

Mid-America Diabetes Associates, Wichita

69120

Universitatsklinikum Heidelberg, Heidelberg

70210

Kuopio University Hospital, Kuopio

72272

Arkansas Children's Hospital, Little Rock

72401

NEA Clinic, Jonesboro

75061

Medical & Surgical Clinic of Irving, Irving

75231

Research Institute of Dallas, Dallas

76008

Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk

76014

Ivano-Frankivsk State Regional Pediatric Clinical Hospital, Ivano-Frankivsk

77074

Southwest Clinical Trials, Houston

77081

Houston Center for Clinical Research, Houston

78217

InVisions Consultants, LLC, San Antonio

78229

Diabetes and Glandular Disease Research Associates, PA, San Antonio

83052

Donetsk Regional Children Clinical Hospital, Donetsk

84403

Endocrine Research Specialists, Ogden

90029

Oulu University Hospital, Oulu

90036

Axis Clinical Trials, Los Angeles

91106

Centre Hospitalier Sud Francilien, Corbeil-Essonnes

92120

San Diego Clinical Trials, San Diego

92506

Clinical Innovations, Inc., Riverside

92626

Clinical Innovations Inc. Research Facility, Costa Mesa

92868

Diabetes Associates Medical Group, Inc, Orange

93003

Ronald Chochinov Md Inc, Ventura

97070

Medical Care & Research, Mérida

98122

University of Washington, Seattle

110002

Maulana Azad Medical College and Associated Hospitals, New Delhi

141001

Dayanand Medical College and Hospital, Ludhiana

201002

Hormone Care & Research Center, Ghaziabad

302017

Fortis Escorts Hospital, Jaipur

380015

DHL Research Centre, Ahmedabad

411001

Grant Medical Foundation, Pune

411011

KEM Hospital Research Center, Pune

440010

Gandhi's Research Institute, Nagpur

440055

Spitalul Judetean de Urgenta Satu Mare, Satu Mare

452001

Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd., Madhya

500001

Medwin Hospitals, Hyderabad

530002

King George Hospital, Visakhapatnam

560043

Bangalore Diabetes Centre, Bangalore

600164

S.C. Minimed S.R.L., Bacau

695011

Health & Research Centre, Trivandrum

700053

B. P. Poddar Hospital & Medical Research Limited, Kolkata

700054

Apollo Glenagles Hospital, Kolkata

751023

Kalinga Hospital Limited, Bhubaneswar

06519

Yale University, New Haven

52242-1083

University of Iowa Children's Hospital, Iowa City

02114

Massachusetts General Hospital, Boston

07039

Saint Barnabas Medical Center, Livingston

3011 TG

Stichting Diabeter, Rotterdam

15-276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

25-734

Wojewódzki Specjalistyczny Szpital Dzieciecy, Kielce

91-738

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4, Lodz

01-184

Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia, Warsaw

50-376

Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu, Wroclaw

020045

Institutul National De Diabet, Nutritie si Boli Metabolice, Bucharest

01135

Ukrainian Children Specialized Clinical Hospital, Kyiv

04114

Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine, Kyiv

CV10 7DJ

George Eliot Hospital NHS Trust, Nuneaton

BS1 3NY

University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology,, Bristol

L9 7AL

Aintree University Hospitals NHS Foundation Trust, Liverpool

SE1 9RT

Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology, London

NG7 2UH

Queens Medical Centre, Diabetes and Endocrinology Unit, Nottingham

S10 2IH

Sheffield Children's Hospital NHS Foundation Trust, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

MacroGenics

INDUSTRY

NCT00920582 - Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus | Biotech Hunter | Biotech Hunter