The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

554

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

June 30, 2010

Study Completion Date

August 31, 2011

Conditions
Type 1 Diabetes Mellitus
Interventions
BIOLOGICAL

Teplizumab

Daily IV dosing for 14 days, repeated at Week 26

DRUG

Placebo

Daily IV dosing for 14 days, repeated at Week 26

Trial Locations (115)

1002

P. Stradins Clinical University Hospital, Riga

8036

Hospital Clinic I Provincial, Barcelona

8916

Hospital Germans Trias i Pujol, Badalona

10034

FN Kralovske Vinohrady, Prague

11040

Schneider Children's Hospital, New Hyde Park

11883

Sodersjukhuset AB, Stockholm

12200

Charité-Hochschulmedizin Berlin, Berlin

12208

Albany Medical Center, Albany

13214

Joslin Diabetes Center, Syracuse

17007

Hospital Universitari Dr. Josep Trueta de Girona, Girona

19047

St. Mary Medical Center, Langhorne

19713

Christiana Care Research Institute, Newark

20725

"Centrul Medical Sanatatea ta", Bucharest

20852

Maryland Diabetes & Endocrine Associates, Rockville

21010

Regional Clinical Endocrinological Dispensary, Vinnitsa

21229

St. Agnes Hospital, Baltimore

22185

Universitetssjukhuset i Lund, Lund

28040

Fundacion Jimenez Diaz, Madrid

28805

Hospital Universitario Principe de Asturias, Alcalá de Henares

29150

Sumter Medical Specialists, Sumter

30309

Atlanta Diabetes Associates, Atlanta

31096

Rambam Medical Centre, Haifa

32545

Herz-und Diabetszentrum Nordrhein-Westfalen, Bad Oeynhausen

33414

Richard Hays, MD, Wellington

35294

UAB School of Medicine, Birmingham

35392

Universitatsklinik Giessen, Giessen

37403

University Diabetes & Endocrine Consultants, Chattanooga

38100

Hillel Yaffe Medical Center, Hadera

38104

Methodist Healthcare, Memphis

40113

Masarykova nemocnice v Usti nad Labem, Ústí nad Labem

42431

Commonwealth Biomedical Research, LLC, Madisonville

44195

Cleveland Clinic, Cleveland

44620

Hospital Mexico-Americano, Guadalajara

46202

Riley Hospital for Children, Indianapolis

48126

Alzohaili Medical Consultants, Dearborn

49202

National Centre for Childhood and Diabetes, Petah Tikva

50005

FN Hradec Kralove, Hradec Králové

51014

Tartu University Hospital, Puusepa

53226

Medical College of Wisconsin, Milwaukee

56261

Chaim Sheba Medical Center, Ramat Gan

56400

Powiatowy Zespot Szpitali w Olesnicy, Oddzial Chorob Wewnetrznych, Oleśnica

58100

Wolfson Medical Centre, Holon

58185

Universitetssjukhuset i Linkoping, Linköping

58633

Nemocnice Jihlava, Jihlava

61070

V. Danilevsky Institute of Endocrine Pathology Problems, Kharkiv

61093

Kharkiv Regional Clinical Children's Hospital, Kharkiv

62500

FN Brno- Detska nemocnice, Brno

64108

The Children's Mercy Hospital, Kansas City

66260

Hospital CIMA Santa Engracia, San Pedro Garza García

67211

Mid-America Diabetes Associates, PA, Wichita

68131

Creighton Diabetes Center, Omaha

69035

Zaporizhzhya Regional Pediatric Hospital, Zaporizhzhya

69120

Universitätsklinikum Heidelberg, Heidelberg

72202

Arkansas Children's Hospital, Little Rock

72401

NEA Clinic, Jonesboro

75231

Research Institute of Dallas, Dallas

78229

Diabetes and Glandular Disease Research, San Antonio

78240

Hospital Central, San Luis Potosí City

78503

Spectra Research Center, McAllen

80045

University of Colorado Health Sciences Center, Aurora

83052

Donetsk Regional Children Clinical Hospital, Donetsk

83404

Rocky Mountain Diabetes & Osteoporosis Center, Idaho Falls

84101

Soroka Medical Centre, Beersheba

84403

Endocrine Research Specialists, Ogden

87702

Humphrey Diabetes Center, Boise

89070

Medizinische Universitätsklinik Ulm, Ulm

91325

Diabetes Medical Center of California, Northridge

92115

I. Szpital Miejski im. Dr. E. Sonnenberga w Lodzi, Lodz

94143

UCSF Medical Center, San Francisco

98122

Pacific Northwest Research Institute, Seattle

110017

Pushpawati Singhania Research Institute, New Delhi

132001

Bharti Research Institute of Diabetes & Endocrinology, Karnāl

302017

Fortis Escorts Hospital, Jaipur

380006

Gujarat Endocrine Centre, Ahmedabad

380015

DHL Research Centre, Ahmedabad

400006

Spitulul Clinic Judetean de Urgenta Cluj, Cluj-Napoca

400067

Diabetes Action Centre, Mumbai

411001

Grant Medical Foundation, Pune

422013

Endocrine Clinic, Nashik

440010

Gandhi Endocrinology and Diabetes Centre, Nagpur

440055

Spitalul Judetean Satu Mare, Satu Mare

452001

Diabetes Thyroid Hormone Research Institute PVT LTD, Indore

500001

Medwin Hospitals, Hyderabad

500082

Nizam's Institute of Medical Sciences, Hyderabad

530002

King George Hospital, Visakhapatnam

560043

Bangalore Diabetes Centre, Bangalore

600164

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

700053

B.P.Poddar Hospital and Medical Research Ltd, Kolkata

700111

Spitalul Clinic Judetean de Urgenta, Iași

06519

Yale University, New Haven

52242-1083

University of Iowa Children's Hospital, Iowa City

02114

Massachusetts General Hospital, Boston

01199

Baystate Medical Center, Springfield

07039

Saint Barnabas Medical Center, Livingston

08901

University of Medicine & Dentistry of NJ, New Brunswick

T3B 6A8

Alberta Children's Hospital, Calgary

R3E0Z2

University of Manitoba, Winnipeg

A1B3V6

University Health Sciences Centre, St. John's

B3H2YN

Capital District Health Authority, Halifax

N6A 5R9

Oxford AIM Clinic, London

N6A5W9

Children's Hospital of Western, London

150 06

Fakultni nemocnice v Motole, Prague

Unknown

East Tallinn Central Hospital, Tallinn

06726

Hospital General de Mexico, Mexico City

3011TG

Diabeter Center for Pediatric and Adolescent Diabetes Care and Research, Rotterdam

15-276

Samodzielny Publiczny Szpital Kliniczny Akademi Medycznej w Bialymstoku, Bialystok

80-952

Oddzial Diabetologiczny Klinika Pediatrii, Gdansk

25-734

Wojewodzki Specjalistyczny Szpital Dzieciecy, Kielce

91-738

Uniwersytecki Szpital Kliniczny, Lodz

51-376

Klinika Endokrynologii i Diabetologii Wieku Rozwojowego, Wroclaw

020045

Institutul de Diabet, Bucharest

02175

Ukrainian Scientific and Practical Center of Endocrine Surgery, Kyiv

Ukranian Children Specialised Clinical Hospital, Kyiv

CB20QQ

Addenbrookes Hospital, Cambridge

EX25DW

Royal Devon and Exeter Hospital, Exeter

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

MacroGenics

INDUSTRY