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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Teplizumab (MGA031)
Placebo
Sponsored by
MacroGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Teplizumab, Protege, Protege Encore, MGA031, Monoclonal antibody, Type 1 Diabetes Mellitus, T1DM, MacroGenics, Recent Onset Diabetes, hOKT3γ1 (Ala-Ala), Encore

Eligibility Criteria

8 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • NEA Clinic
  • Arkansas Children's Hospital
  • Clinical Innovations Inc. Research Facility
  • Axis Clinical Trials
  • Diabetes Associates Medical Group, Inc
  • Clinical Innovations, Inc.
  • San Diego Clinical Trials
  • Ronald Chochinov Md Inc
  • Yale University
  • Christiana Care Research Institute
  • Richard Hays, MD
  • Atlanta Diabetes Associates
  • John H Stoger Jr. Hospital of Cook County, Cook County Hospital
  • Indiana University School of Medicine
  • University of Iowa Children's Hospital
  • Mid-America Diabetes Associates
  • St. Agnes Hospital
  • Maryland Diabetes & Endocrine Associates
  • Massachusetts General Hospital
  • Alzohaili Medical Consultants
  • Children's Hospitals and Clinics of Minnesota
  • University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology
  • The Children's Mercy Hospital
  • Saint Barnabas Medical Center
  • Albany Medical College
  • Bassett Healthcare
  • East Carolina University, Brody School of Medicine
  • Children's Hospital of Philadelphia
  • GHS Pediatric Endocrinology
  • AM Diabetes & Endocrinology Center
  • University Diabetes & Endocrine Consultants
  • LeBonheur Children's Medical Center
  • Research Institute of Dallas
  • Southwest Clinical Trials
  • Houston Center for Clinical Research
  • Medical & Surgical Clinic of Irving
  • InVisions Consultants, LLC
  • Diabetes and Glandular Disease Research Associates, PA
  • Endocrine Research Specialists
  • Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism
  • University of Washington
  • Universitair Ziekenhuis Antwerpen
  • Cliniques du Sud Luxembourg - Vivalia
  • I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice
  • Klinika deti a dorostu FN Kralovske Vinohrady
  • Centrum diabetologie, Institut klinicke a experimentalni mediciny
  • Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole
  • Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z.
  • Kuopio University Hospital
  • Central Hospital of Mikkeli
  • Oulu University Hospital
  • CHU de Brest Hôpital de la Cavale Blanche
  • CHU de Besançon
  • CHU de Reims
  • Centre Hospitalier Sud Francilien
  • CHU de Bordeaux
  • Hôpitaux Universitaires de Strasbourg Hôpital Civil
  • Diabetes-Klinik Bad Nauheim GmbH
  • Herz und Diabeteszentrum Nordrhein-Westfallen
  • Charite, Campus Benjamin Franklin
  • Universitätsklinikum Düsseldorf
  • Universitatsklinik Giessen
  • Asklepios Westklinikum Hamburg
  • Kinderkrankenhaus auf der Bult
  • Universitatsklinikum Heidelberg
  • Medwin Hospitals
  • King George Hospital
  • Maulana Azad Medical College and Associated Hospitals
  • DHL Research Centre
  • Bangalore Diabetes Centre
  • Health & Research Centre
  • Gandhi's Research Institute
  • Grant Medical Foundation
  • KEM Hospital Research Center
  • Kalinga Hospital Limited
  • Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd.
  • Dayanand Medical College and Hospital
  • Fortis Escorts Hospital
  • Hormone Care & Research Center
  • B. P. Poddar Hospital & Medical Research Limited
  • Apollo Glenagles Hospital
  • Mayer Children's Hospital of Haifa
  • Hillel Yaffe Medical Center
  • The E. Wolfson Medical Center
  • Schneider Children's Medical
  • The Safra Children's Hospital, The Chaim Sheba Medical Center
  • U.O. di Malattie del Metabolismo
  • Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena,
  • U.O. di Malattie Metaboliche e Diabetologia
  • Hospital y Clinica OCA / Monterrey International Research Center
  • Medical Care & Research
  • Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.
  • Stichting Diabeter
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Uniwersyteckie Centrum Kliniczne
  • Wojewódzki Specjalistyczny Szpital Dzieciecy
  • Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia
  • Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4
  • S.C. Minimed S.R.L.
  • Institutul National De Diabet, Nutritie si Boli Metabolice
  • Spitalul Judetean de Urgenta Satu Mare
  • Hospital Universitario Principe de Asturias
  • Hospital Dr. Josep Trueta
  • Donetsk Regional Children Clinical Hospital
  • Ivano-Frankivsk Regional Clinical Hospital
  • Ivano-Frankivsk State Regional Pediatric Clinical Hospital
  • Kharkiv Regional Clinical Children Hospital, Department of Endocrinology
  • Ukrainian Children Specialized Clinical Hospital
  • Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine
  • Regional Clinical Endocrinology Dispensary of MoH Ukraine
  • George Eliot Hospital NHS Trust
  • University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology,
  • Aintree University Hospitals NHS Foundation Trust
  • Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology
  • Queens Medical Centre, Diabetes and Endocrinology Unit
  • Sheffield Children's Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Successful versus unsuccessful clinical responses. A successful response requires that both components of a composite endpoint are met. The composite endpoint includes both the subject's total daily insulin usage and his/her HbA1c levels.

Secondary Outcome Measures

Successful versus unsuccessful clinical responses. A successful response requires that both components of a composite endpoint are met. The composite endpoint includes both the subject's total daily insulin usage and his/her HbA1c levels
C-peptide secretory responses, as defined by the total area under the curve of the C-peptide response to a mixed meal

Full Information

First Posted
June 12, 2009
Last Updated
February 4, 2022
Sponsor
MacroGenics
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00920582
Brief Title
Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacroGenics
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Teplizumab, Protege, Protege Encore, MGA031, Monoclonal antibody, Type 1 Diabetes Mellitus, T1DM, MacroGenics, Recent Onset Diabetes, hOKT3γ1 (Ala-Ala), Encore

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Teplizumab (MGA031)
Other Intervention Name(s)
MGA031
Intervention Description
IV dosing daily for 14 days times 2 courses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV dosing daily for 14 days times 2 courses
Primary Outcome Measure Information:
Title
Successful versus unsuccessful clinical responses. A successful response requires that both components of a composite endpoint are met. The composite endpoint includes both the subject's total daily insulin usage and his/her HbA1c levels.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Successful versus unsuccessful clinical responses. A successful response requires that both components of a composite endpoint are met. The composite endpoint includes both the subject's total daily insulin usage and his/her HbA1c levels
Time Frame
Up to 24 months
Title
C-peptide secretory responses, as defined by the total area under the curve of the C-peptide response to a mixed meal
Time Frame
12 and up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
NEA Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72272
Country
United States
Facility Name
Clinical Innovations Inc. Research Facility
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Diabetes Associates Medical Group, Inc
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Clinical Innovations, Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Ronald Chochinov Md Inc
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Christiana Care Research Institute
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Richard Hays, MD
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
John H Stoger Jr. Hospital of Cook County, Cook County Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Children's Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1083
Country
United States
Facility Name
Mid-America Diabetes Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67211
Country
United States
Facility Name
St. Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Maryland Diabetes & Endocrine Associates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Alzohaili Medical Consultants
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Bassett Healthcare
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Facility Name
East Carolina University, Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
GHS Pediatric Endocrinology
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
AM Diabetes & Endocrinology Center
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
University Diabetes & Endocrine Consultants
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
LeBonheur Children's Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Southwest Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Houston Center for Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Medical & Surgical Clinic of Irving
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
InVisions Consultants, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Diabetes and Glandular Disease Research Associates, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Endocrine Research Specialists
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Cliniques du Sud Luxembourg - Vivalia
City
Luxembourg
ZIP/Postal Code
6700
Country
Belgium
Facility Name
I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Klinika deti a dorostu FN Kralovske Vinohrady
City
Praha
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Centrum diabetologie, Institut klinicke a experimentalni mediciny
City
Praha
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole
City
Praha
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z.
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czechia
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Central Hospital of Mikkeli
City
Mikkeli
ZIP/Postal Code
50100
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
CHU de Brest Hôpital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU de Besançon
City
Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
CHU de Reims
City
Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
CHU de Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Diabetes-Klinik Bad Nauheim GmbH
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Herz und Diabeteszentrum Nordrhein-Westfallen
City
Bad Oeyenhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Charite, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
20225
Country
Germany
Facility Name
Universitatsklinik Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Asklepios Westklinikum Hamburg
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Kinderkrankenhaus auf der Bult
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Universitatsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Medwin Hospitals
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500001
Country
India
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Maulana Azad Medical College and Associated Hospitals
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
DHL Research Centre
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Bangalore Diabetes Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560043
Country
India
Facility Name
Health & Research Centre
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Gandhi's Research Institute
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Grant Medical Foundation
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
KEM Hospital Research Center
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
Kalinga Hospital Limited
City
Bhubaneswar
State/Province
Orissa
ZIP/Postal Code
751023
Country
India
Facility Name
Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd.
City
Madhya
State/Province
Pradesh
ZIP/Postal Code
452001
Country
India
Facility Name
Dayanand Medical College and Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
Fortis Escorts Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Hormone Care & Research Center
City
Ghaziabad
State/Province
Uttar Pradesh
ZIP/Postal Code
201002
Country
India
Facility Name
B. P. Poddar Hospital & Medical Research Limited
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700053
Country
India
Facility Name
Apollo Glenagles Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Mayer Children's Hospital of Haifa
City
Bat-Galim
State/Province
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
The E. Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Schneider Children's Medical
City
Petach-Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
The Safra Children's Hospital, The Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
U.O. di Malattie del Metabolismo
City
Genova Pisa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena,
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
U.O. di Malattie Metaboliche e Diabetologia
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Hospital y Clinica OCA / Monterrey International Research Center
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Medical Care & Research
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.
City
Mexico, Distrito Federal
ZIP/Postal Code
11650
Country
Mexico
Facility Name
Stichting Diabeter
City
Rotterdam
ZIP/Postal Code
3011 TG
Country
Netherlands
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Wojewódzki Specjalistyczny Szpital Dzieciecy
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia
City
Warszawa
ZIP/Postal Code
01-184
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-376
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4
City
Łódź
ZIP/Postal Code
91-738
Country
Poland
Facility Name
S.C. Minimed S.R.L.
City
Bacau
ZIP/Postal Code
600164
Country
Romania
Facility Name
Institutul National De Diabet, Nutritie si Boli Metabolice
City
Bucuresti
ZIP/Postal Code
020045
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Satu Mare
City
Satu-Mare
ZIP/Postal Code
440055
Country
Romania
Facility Name
Hospital Universitario Principe de Asturias
City
Alcala de Henares
ZIP/Postal Code
28805
Country
Spain
Facility Name
Hospital Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Donetsk Regional Children Clinical Hospital
City
Donetsk
ZIP/Postal Code
83052
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Ivano-Frankivsk State Regional Pediatric Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Kharkiv Regional Clinical Children Hospital, Department of Endocrinology
City
Kharkiv
ZIP/Postal Code
61093
Country
Ukraine
Facility Name
Ukrainian Children Specialized Clinical Hospital
City
Kyiv
ZIP/Postal Code
01135
Country
Ukraine
Facility Name
Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Regional Clinical Endocrinology Dispensary of MoH Ukraine
City
Vinnitsa
ZIP/Postal Code
21010
Country
Ukraine
Facility Name
George Eliot Hospital NHS Trust
City
Nuneaton
State/Province
Warwickshire
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
Facility Name
University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology,
City
Bristol
ZIP/Postal Code
BS1 3NY
Country
United Kingdom
Facility Name
Aintree University Hospitals NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Queens Medical Centre, Diabetes and Endocrinology Unit
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Sheffield Children's Hospital NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2IH
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://protegediabetes.org
Description
Website containing information on Protege Program

Learn more about this trial

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

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