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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Teplizumab
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 Randomized, Double Blind, Parallel Group, Controlled Clinical Trial

Eligibility Criteria

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

Inclusion Criteria:

Subjects must meet all of the following criteria:

  1. Enrollment (Segment #1) or randomization (Segment #2) on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. Study Day 0 is the first day of study drug dosing.
  2. Diagnosis of type 1 diabetes mellitus, according to the American Diabetes Association (ADA) criteria
  3. Requirement for injected insulin therapy
  4. Have a detectable fasting or stimulated C-peptide level (above the lower limit of detection of the assay)

  5. One positive result on testing for any of the following antibodies:

    1. islet-cell autoantibodies (ICA512/IA-2),
    2. glutamic acid decarboxylase autoantibodies, or
    3. insulin autoantibodies (if present during first 2 weeks, but not beyond 2 weeks, of insulin treatment)
  6. Male or female

  7. Subject must be in one of the following age groups:

    • Age 18-35 years
    • Age 12-17 years pending approval by Data Monitoring Committee
    • Age 8-11 years pending approval by Data Monitoring Committee
  8. Body weight ≥ 36 kg

Exclusion Criteria:

Subjects must have none of the following:

  1. Prior administration of a monoclonal antibody -- within the 1 year before enrollment or randomization at Study Day 0 -- that could potentially prevent or confound a therapeutic response to MGA031
  2. Participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks before enrollment or randomization
  3. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
  4. Pregnant or lactating females
  5. Prior murine OKT®3 treatment at any time before enrollment or randomization
  6. Current or planned therapy with exenatide or any other agents that stimulate pancreatic beta cell regeneration or insulin secretion
  7. Current or planned therapy with inhaled insulin
  8. Uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease, or other serious cardiac disease within the 12 weeks before enrollment or randomization
  9. History of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or cerebrovascular disease
  10. Newly diagnosed hypothyroidism (not currently being treated but which, in the opinion of the investigator, should be treated) or active Graves' disease
  11. Eczema, asthma or severe atopic disease requiring treatment within the 12 weeks before enrollment or randomization
  12. Evidence of active infection, such as fever ≥ 38.0 degrees Celsius (100.5 degrees Fahrenheit)
  13. Known or suspected infection with human immunodeficiency virus (HIV)
  14. Evidence of active hepatitis B (HBV) or hepatitis C virus (HCV)
  15. Evidence of active or latent tuberculosis
  16. Vaccination with a live virus within the 12 weeks before enrollment or randomization or planned live virus vaccination continuing through week 52 of the study. Vaccination with an antigen or killed organism must not be given within 12 weeks before or planned within 8 weeks after each dosing cycle.
  17. Any infectious mononucleosis-like illness within the 6 months before enrollment or randomization
  18. Serologic and clinical evidence of acute infection with Epstein-Barr virus (EBV)
  19. Serologic evidence of acute infection with cytomegalovirus (CMV)

Sites / Locations

  • UAB School of Medicine
  • NEA Clinic
  • Arkansas Children's Hospital
  • Diabetes Medical Center of California
  • UCSF Medical Center
  • University of Colorado Health Sciences Center
  • Yale University
  • Christiana Care Research Institute
  • Richard Hays, MD
  • Atlanta Diabetes Associates
  • Humphrey Diabetes Center
  • Rocky Mountain Diabetes & Osteoporosis Center
  • Riley Hospital for Children
  • University of Iowa Children's Hospital
  • Mid-America Diabetes Associates, PA
  • Commonwealth Biomedical Research, LLC
  • St. Agnes Hospital
  • Maryland Diabetes & Endocrine Associates
  • Massachusetts General Hospital
  • Baystate Medical Center
  • Alzohaili Medical Consultants
  • The Children's Mercy Hospital
  • Creighton Diabetes Center
  • Saint Barnabas Medical Center
  • University of Medicine & Dentistry of NJ
  • Albany Medical Center
  • Schneider Children's Hospital
  • Joslin Diabetes Center
  • Cleveland Clinic
  • St. Mary Medical Center
  • Sumter Medical Specialists
  • University Diabetes & Endocrine Consultants
  • Methodist Healthcare
  • Research Institute of Dallas
  • Spectra Research Center
  • Diabetes and Glandular Disease Research
  • Endocrine Research Specialists
  • Pacific Northwest Research Institute
  • Medical College of Wisconsin
  • Alberta Children's Hospital
  • University of Manitoba
  • University Health Sciences Centre
  • Capital District Health Authority
  • Oxford AIM Clinic
  • Children's Hospital of Western
  • FN Brno- Detska nemocnice
  • FN Hradec Kralove
  • Nemocnice Jihlava
  • FN Kralovske Vinohrady
  • Fakultni nemocnice v Motole
  • Masarykova nemocnice v Usti nad Labem
  • East Tallinn Central Hospital
  • Tartu University Hospital
  • Universitätsklinikum Heidelberg
  • Medizinische Universitätsklinik Ulm
  • Herz-und Diabetszentrum Nordrhein-Westfalen
  • Charité-Hochschulmedizin Berlin
  • Universitatsklinik Giessen
  • Nizam's Institute of Medical Sciences
  • King George Hospital
  • Gujarat Endocrine Centre
  • DHL Research Centre
  • Bharti Research Institute of Diabetes & Endocrinology
  • Bangalore Diabetes Centre
  • Diabetes Thyroid Hormone Research Institute PVT LTD
  • Diabetes Action Centre
  • Gandhi Endocrinology and Diabetes Centre
  • Endocrine Clinic
  • Grant Medical Foundation
  • Fortis Escorts Hospital
  • B.P.Poddar Hospital and Medical Research Ltd
  • Medwin Hospitals
  • Pushpawati Singhania Research Institute
  • Soroka Medical Centre
  • Hillel Yaffe Medical Center
  • Rambam Medical Centre
  • Wolfson Medical Centre
  • National Centre for Childhood and Diabetes
  • Chaim Sheba Medical Center
  • P. Stradins Clinical University Hospital
  • Hospital CIMA Santa Engracia
  • Hospital Mexico-Americano
  • Hospital General de Mexico
  • Hospital Central
  • Diabeter Center for Pediatric and Adolescent Diabetes Care and Research
  • Samodzielny Publiczny Szpital Kliniczny Akademi Medycznej w Bialymstoku
  • Oddzial Diabetologiczny Klinika Pediatrii
  • Wojewodzki Specjalistyczny Szpital Dzieciecy
  • I. Szpital Miejski im. Dr. E. Sonnenberga w Lodzi
  • Uniwersytecki Szpital Kliniczny
  • Powiatowy Zespot Szpitali w Olesnicy, Oddzial Chorob Wewnetrznych
  • Klinika Endokrynologii i Diabetologii Wieku Rozwojowego
  • S.C. Minimed S.R.L.
  • Institutul de Diabet
  • Centrul Medical "Sanatatea ta"
  • Spitulul Clinic Judetean de Urgenta Cluj
  • Spitalul Clinic Judetean de Urgenta
  • Spitalul Judetean Satu Mare
  • Hospital Universitari Dr. Josep Trueta de Girona
  • Hospital Universitario Principe de Asturias
  • Hospital Germans Trias i Pujol
  • Hospital Clinic I Provincial
  • Fundacion Jimenez Diaz
  • Universitetssjukhuset i Linkoping
  • Universitetssjukhuset i Lund
  • Sodersjukhuset AB
  • Donetsk Regional Children Clinical Hospital
  • V. Danilevsky Institute of Endocrine Pathology Problems
  • Kharkiv Regional Clinical Children's Hospital
  • Ukrainian Scientific and Practical Center of Endocrine Surgery
  • Ukranian Children Specialised Clinical Hospital
  • Regional Clinical Endocrinological Dispensary
  • Zaporizhzhya Regional Pediatric Hospital
  • Addenbrookes Hospital
  • Royal Devon and Exeter Hospital

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

The first primary endpoint is a composite endpoint at 52 weeks: the proportion of subjects with both a total daily insulin dose of less than 0.5 U/kg/day and HbA1c level of less than 6.5%.
The second primary endpoint is the mean HbA1c change from baseline at 52 weeks after randomization.

Secondary Outcome Measures

Change from baseline in C-peptide AUC at 52 Weeks and 104 weeks after randomization.
The proportion of subjects at 104 weeks after randomization, that have both a total daily insulin dose of less than 0.5 U/kg/day and HbA1c level of less than 6.5%
The proportion of subjects at 52 weeks after randomization, that have both a total daily insulin dose of less than 0.5 U/kg/day and HbA1c level of less than 7.0%.
Mean HbA1c change from baseline at 104 weeks after randomization.

Full Information

First Posted
October 7, 2006
Last Updated
February 4, 2022
Sponsor
MacroGenics
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00385697
Brief Title
The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Official Title
A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of 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
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2011 (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 protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to insulin and other standard of care treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels. Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics, Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.
Detailed Description
The Protégé Study - A Multinational Clinical Trial of MGA031 for Preserving the Capability to Produce Insulin, Reducing Insulin Usage and Improving Blood Sugar Levels in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Randomized, Double Blind, Parallel Group, Controlled Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
554 (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
Other Intervention Name(s)
MGA031
Intervention Description
IV dosing daily for 14 days times 2 courses
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
IV dosing daily for 14 days times 2 courses
Primary Outcome Measure Information:
Title
The first primary endpoint is a composite endpoint at 52 weeks: the proportion of subjects with both a total daily insulin dose of less than 0.5 U/kg/day and HbA1c level of less than 6.5%.
Time Frame
at 12 months
Title
The second primary endpoint is the mean HbA1c change from baseline at 52 weeks after randomization.
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Change from baseline in C-peptide AUC at 52 Weeks and 104 weeks after randomization.
Time Frame
at 24 months
Title
The proportion of subjects at 104 weeks after randomization, that have both a total daily insulin dose of less than 0.5 U/kg/day and HbA1c level of less than 6.5%
Time Frame
at 24 months
Title
The proportion of subjects at 52 weeks after randomization, that have both a total daily insulin dose of less than 0.5 U/kg/day and HbA1c level of less than 7.0%.
Time Frame
at 12 months
Title
Mean HbA1c change from baseline at 104 weeks after randomization.
Time Frame
at 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 must meet all of the following criteria: Enrollment (Segment #1) or randomization (Segment #2) on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. Study Day 0 is the first day of study drug dosing. Diagnosis of type 1 diabetes mellitus, according to the American Diabetes Association (ADA) criteria Requirement for injected insulin therapy Have a detectable fasting or stimulated C-peptide level (above the lower limit of detection of the assay) One positive result on testing for any of the following antibodies: islet-cell autoantibodies (ICA512/IA-2), glutamic acid decarboxylase autoantibodies, or insulin autoantibodies (if present during first 2 weeks, but not beyond 2 weeks, of insulin treatment) Male or female Subject must be in one of the following age groups: Age 18-35 years Age 12-17 years pending approval by Data Monitoring Committee Age 8-11 years pending approval by Data Monitoring Committee Body weight ≥ 36 kg Exclusion Criteria: Subjects must have none of the following: Prior administration of a monoclonal antibody -- within the 1 year before enrollment or randomization at Study Day 0 -- that could potentially prevent or confound a therapeutic response to MGA031 Participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks before enrollment or randomization Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial Pregnant or lactating females Prior murine OKT®3 treatment at any time before enrollment or randomization Current or planned therapy with exenatide or any other agents that stimulate pancreatic beta cell regeneration or insulin secretion Current or planned therapy with inhaled insulin Uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease, or other serious cardiac disease within the 12 weeks before enrollment or randomization History of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or cerebrovascular disease Newly diagnosed hypothyroidism (not currently being treated but which, in the opinion of the investigator, should be treated) or active Graves' disease Eczema, asthma or severe atopic disease requiring treatment within the 12 weeks before enrollment or randomization Evidence of active infection, such as fever ≥ 38.0 degrees Celsius (100.5 degrees Fahrenheit) Known or suspected infection with human immunodeficiency virus (HIV) Evidence of active hepatitis B (HBV) or hepatitis C virus (HCV) Evidence of active or latent tuberculosis Vaccination with a live virus within the 12 weeks before enrollment or randomization or planned live virus vaccination continuing through week 52 of the study. Vaccination with an antigen or killed organism must not be given within 12 weeks before or planned within 8 weeks after each dosing cycle. Any infectious mononucleosis-like illness within the 6 months before enrollment or randomization Serologic and clinical evidence of acute infection with Epstein-Barr virus (EBV) Serologic evidence of acute infection with cytomegalovirus (CMV)
Facility Information:
Facility Name
UAB School of Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
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
72202
Country
United States
Facility Name
Diabetes Medical Center of California
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
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
Humphrey Diabetes Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
87702
Country
United States
Facility Name
Rocky Mountain Diabetes & Osteoporosis Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Riley Hospital for Children
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, PA
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67211
Country
United States
Facility Name
Commonwealth Biomedical Research, LLC
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
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
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Alzohaili Medical Consultants
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
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
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
University of Medicine & Dentistry of NJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Joslin Diabetes Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13214
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
St. Mary Medical Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Sumter Medical Specialists
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
University Diabetes & Endocrine Consultants
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Methodist Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Spectra Research Center
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Diabetes and Glandular Disease Research
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
Pacific Northwest Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E0Z2
Country
Canada
Facility Name
University Health Sciences Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B3V6
Country
Canada
Facility Name
Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2YN
Country
Canada
Facility Name
Oxford AIM Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R9
Country
Canada
Facility Name
Children's Hospital of Western
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada
Facility Name
FN Brno- Detska nemocnice
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
FN Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Nemocnice Jihlava
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
FN Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Masarykova nemocnice v Usti nad Labem
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czechia
Facility Name
East Tallinn Central Hospital
City
Ravi
State/Province
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Tartu University Hospital
City
Puusepa
State/Province
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Medizinische Universitätsklinik Ulm
City
Ulm
State/Province
Baden-Wurttemberg
ZIP/Postal Code
89070
Country
Germany
Facility Name
Herz-und Diabetszentrum Nordrhein-Westfalen
City
Bad Oeynhausen
State/Province
North Rhine-Westphalia
ZIP/Postal Code
32545
Country
Germany
Facility Name
Charité-Hochschulmedizin Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitatsklinik Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Nizam's Institute of Medical Sciences
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Gujarat Endocrine Centre
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
DHL Research Centre
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Bharti Research Institute of Diabetes & Endocrinology
City
Karnal
State/Province
Haryana
ZIP/Postal Code
132001
Country
India
Facility Name
Bangalore Diabetes Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560043
Country
India
Facility Name
Diabetes Thyroid Hormone Research Institute PVT LTD
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452001
Country
India
Facility Name
Diabetes Action Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400067
Country
India
Facility Name
Gandhi Endocrinology and Diabetes Centre
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Endocrine Clinic
City
Nasik
State/Province
Maharashtra
ZIP/Postal Code
422013
Country
India
Facility Name
Grant Medical Foundation
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Fortis Escorts Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
B.P.Poddar Hospital and Medical Research Ltd
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700053
Country
India
Facility Name
Medwin Hospitals
City
Hyderabad
ZIP/Postal Code
500001
Country
India
Facility Name
Pushpawati Singhania Research Institute
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Soroka Medical Centre
City
Beer Sheba
ZIP/Postal Code
84101
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Rambam Medical Centre
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Wolfson Medical Centre
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
National Centre for Childhood and Diabetes
City
Petach Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
56261
Country
Israel
Facility Name
P. Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Hospital CIMA Santa Engracia
City
San Pedro Garza García
State/Province
Nuevo Leon
ZIP/Postal Code
66260
Country
Mexico
Facility Name
Hospital Mexico-Americano
City
Guadalajara
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Hospital General de Mexico
City
Mexico City
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Hospital Central
City
San Luis Potosí
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Diabeter Center for Pediatric and Adolescent Diabetes Care and Research
City
Rotterdam
ZIP/Postal Code
3011TG
Country
Netherlands
Facility Name
Samodzielny Publiczny Szpital Kliniczny Akademi Medycznej w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Oddzial Diabetologiczny Klinika Pediatrii
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
I. Szpital Miejski im. Dr. E. Sonnenberga w Lodzi
City
Kodz
ZIP/Postal Code
92115
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny
City
Lodz
ZIP/Postal Code
91-738
Country
Poland
Facility Name
Powiatowy Zespot Szpitali w Olesnicy, Oddzial Chorob Wewnetrznych
City
Olesnica
ZIP/Postal Code
56400
Country
Poland
Facility Name
Klinika Endokrynologii i Diabetologii Wieku Rozwojowego
City
Wroclaw
ZIP/Postal Code
51-376
Country
Poland
Facility Name
S.C. Minimed S.R.L.
City
Bacau
ZIP/Postal Code
600164
Country
Romania
Facility Name
Institutul de Diabet
City
Bucharest
ZIP/Postal Code
020045
Country
Romania
Facility Name
Centrul Medical "Sanatatea ta"
City
Bucuresti
ZIP/Postal Code
20725
Country
Romania
Facility Name
Spitulul Clinic Judetean de Urgenta Cluj
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta
City
Iasi
ZIP/Postal Code
700111
Country
Romania
Facility Name
Spitalul Judetean Satu Mare
City
Satu Mare
ZIP/Postal Code
440055
Country
Romania
Facility Name
Hospital Universitari Dr. Josep Trueta de Girona
City
Girona
State/Province
Gerona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Principe de Asturias
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Universitetssjukhuset i Linkoping
City
Linkoping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Universitetssjukhuset i Lund
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Sodersjukhuset AB
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Donetsk Regional Children Clinical Hospital
City
Donetsk
ZIP/Postal Code
83052
Country
Ukraine
Facility Name
V. Danilevsky Institute of Endocrine Pathology Problems
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Kharkiv Regional Clinical Children's Hospital
City
Kharkiv
ZIP/Postal Code
61093
Country
Ukraine
Facility Name
Ukrainian Scientific and Practical Center of Endocrine Surgery
City
Kyiv
ZIP/Postal Code
02175
Country
Ukraine
Facility Name
Ukranian Children Specialised Clinical Hospital
City
Kyiv
ZIP/Postal Code
02175
Country
Ukraine
Facility Name
Regional Clinical Endocrinological Dispensary
City
Vinnitsa
ZIP/Postal Code
21010
Country
Ukraine
Facility Name
Zaporizhzhya Regional Pediatric Hospital
City
Zaporizhzhya
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Addenbrookes Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB20QQ
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX25DW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21719095
Citation
Sherry N, Hagopian W, Ludvigsson J, Jain SM, Wahlen J, Ferry RJ Jr, Bode B, Aronoff S, Holland C, Carlin D, King KL, Wilder RL, Pillemer S, Bonvini E, Johnson S, Stein KE, Koenig S, Herold KC, Daifotis AG; Protege Trial Investigators. Teplizumab for treatment of type 1 diabetes (Protege study): 1-year results from a randomised, placebo-controlled trial. Lancet. 2011 Aug 6;378(9790):487-97. doi: 10.1016/S0140-6736(11)60931-8. Epub 2011 Jun 28.
Results Reference
derived

Learn more about this trial

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

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