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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
MacroGenics
ClinicalTrials.gov Identifier:
NCT00920582
First received: June 12, 2009
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: Teplizumab (MGA031)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by MacroGenics:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 254
Study Start Date: September 2009
Study Completion Date: July 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Teplizumab (MGA031)
IV dosing daily for 14 days times 2 courses
Other Name: MGA031
Experimental: 2 Drug: Teplizumab (MGA031)
IV dosing daily for 14 days times 2 courses
Other Name: MGA031
Experimental: 3 Drug: Teplizumab (MGA031)
IV dosing daily for 14 days times 2 courses
Other Name: MGA031
Placebo Comparator: 4 Drug: Placebo
IV dosing daily for 14 days times 2 courses

  Eligibility

Ages Eligible for Study:   8 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920582

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arkansas
NEA Clinic
Jonesboro, Arkansas, United States, 72401
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72272
United States, California
Clinical Innovations Inc. Research Facility
Costa Mesa, California, United States, 92626
Axis Clinical Trials
Los Angeles, California, United States, 90036
Diabetes Associates Medical Group, Inc
Orange, California, United States, 92868
Clinical Innovations, Inc.
Riverside, California, United States, 92506
San Diego Clinical Trials
San Diego, California, United States, 92120
Ronald Chochinov Md Inc
Ventura, California, United States, 93003
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Delaware
Christiana Care Research Institute
Newark, Delaware, United States, 19713
United States, Florida
Richard Hays, MD
Wellington, Florida, United States, 33414
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
United States, Illinois
John H Stoger Jr. Hospital of Cook County, Cook County Hospital
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Children's Hospital
Iowa City, Iowa, United States, 52242-1083
United States, Kansas
Mid-America Diabetes Associates
Wichita, Kansas, United States, 67211
United States, Maryland
St. Agnes Hospital
Baltimore, Maryland, United States, 21229
Maryland Diabetes & Endocrine Associates
Rockville, Maryland, United States, 20852
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Alzohaili Medical Consultants
Dearborn, Michigan, United States, 48126
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
St Paul, Minnesota, United States, 55102
United States, Missouri
University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology
Columbia, Missouri, United States, 65212
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Bassett Healthcare
Cooperstown, New York, United States, 13326
United States, North Carolina
East Carolina University, Brody School of Medicine
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
GHS Pediatric Endocrinology
Greenville, South Carolina, United States, 29615
United States, Tennessee
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, United States, 38133
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States, 37403
LeBonheur Children's Medical Center
Memphis, Tennessee, United States, 38103
United States, Texas
Research Institute of Dallas
Dallas, Texas, United States, 75231
Houston Center for Clinical Research
Houston, Texas, United States, 77081
Southwest Clinical Trials
Houston, Texas, United States, 77074
Medical & Surgical Clinic of Irving
Irving, Texas, United States, 75061
InVisions Consultants, LLC
San Antonio, Texas, United States, 78217
Diabetes and Glandular Disease Research Associates, PA
San Antonio, Texas, United States, 78229
United States, Utah
Endocrine Research Specialists
Ogden, Utah, United States, 84403
United States, Virginia
Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism
Richmond, Virginia, United States, 23219
United States, Washington
University of Washington
Seattle, Washington, United States, 98122
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium, 2650
Cliniques du Sud Luxembourg - Vivalia
Luxembourg, Belgium, 6700
Czech Republic
I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice
Brno, Czech Republic, 62500
Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole
Praha, Czech Republic, 15006
Klinika deti a dorostu FN Kralovske Vinohrady
Praha, Czech Republic, 10034
Centrum diabetologie, Institut klinicke a experimentalni mediciny
Praha, Czech Republic, 14021
Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z.
Usti nad Labem, Czech Republic, 40113
Finland
Kuopio University Hospital
Kuopio, Finland, 70210
Central Hospital of Mikkeli
Mikkeli, Finland, 50100
Oulu University Hospital
Oulu, Finland, 90029
France
CHU de Brest Hôpital de la Cavale Blanche
Brest, France, 29609
CHU de Besançon
Cedex, France, 25030
CHU de Reims
Cedex, France, 51092
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91106
CHU de Bordeaux
Pessac, France, 33604
Hôpitaux Universitaires de Strasbourg Hôpital Civil
Strasbourg, France, 67091
Germany
Diabetes-Klinik Bad Nauheim GmbH
Bad Nauheim, Germany, 61231
Herz und Diabeteszentrum Nordrhein-Westfallen
Bad Oeyenhausen, Germany, 32545
Charite, Campus Benjamin Franklin
Berlin, Germany, 12200
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 20225
Universitatsklinik Giessen
Giessen, Germany, 35392
Asklepios Westklinikum Hamburg
Hamburg, Germany, 22559
Kinderkrankenhaus auf der Bult
Hannover, Germany, 30173
Universitatsklinikum Heidelberg
Heidelberg, Germany, 69120
India
Medwin Hospitals
Hyderabad, Andhra Pradesh, India, 500001
King George Hospital
Visakhapatnam, Andhra Pradesh, India, 530002
Maulana Azad Medical College and Associated Hospitals
New Delhi, Delhi, India, 110002
DHL Research Centre
Ahmedabad, Gujarat, India, 380015
Bangalore Diabetes Centre
Bangalore, Karnataka, India, 560043
Health & Research Centre
Trivandrum, Kerala, India, 695011
Gandhi's Research Institute
Nagpur, Maharashtra, India, 440010
Grant Medical Foundation
Pune, Maharashtra, India, 411001
KEM Hospital Research Center
Pune, Maharashtra, India, 411011
Kalinga Hospital Limited
Bhubaneswar, Orissa, India, 751023
Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd.
Madhya, Pradesh, India, 452001
Dayanand Medical College and Hospital
Ludhiana, Punjab, India, 141001
Fortis Escorts Hospital
Jaipur, Rajasthan, India, 302017
Hormone Care & Research Center
Ghaziabad, Uttar Pradesh, India, 201002
Apollo Glenagles Hospital
Kolkata, West Bengal, India, 700054
B. P. Poddar Hospital & Medical Research Limited
Kolkata, West Bengal, India, 700053
Israel
Mayer Children's Hospital of Haifa
Bat-Galim, Haifa, Israel, 31096
Hillel Yaffe Medical Center
Hadera, Israel, 38100
The E. Wolfson Medical Center
Holon, Israel, 58100
Schneider Children's Medical
Petach-Tikva, Israel, 49202
The Safra Children's Hospital, The Chaim Sheba Medical Center
Ramat-Gan, Israel, 52621
Italy
U.O. di Malattie del Metabolismo
Genova Pisa, Italy, 16132
Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena,
Modena, Italy, 41124
U.O. di Malattie Metaboliche e Diabetologia
Pisa, Italy, 56124
Mexico
Hospital y Clinica OCA / Monterrey International Research Center
Monterrey, Nuevo León, Mexico, 64000
Medical Care & Research
Merida, Yucatan, Mexico, 97070
Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.
Mexico, Distrito Federal, Mexico, 11650
Netherlands
Stichting Diabeter
Rotterdam, Netherlands, 3011 TG
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland, 15-276
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Wojewódzki Specjalistyczny Szpital Dzieciecy
Kielce, Poland, 25-734
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia
Warszawa, Poland, 01-184
Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu
Wroclaw, Poland, 50-376
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4
Łódź, Poland, 91-738
Romania
S.C. Minimed S.R.L.
Bacau, Romania, 600164
Institutul National De Diabet, Nutritie si Boli Metabolice
Bucuresti, Romania, 020045
Spitalul Judetean de Urgenta Satu Mare
Satu-Mare, Romania, 440055
Spain
Hospital Universitario Principe de Asturias
Alcala de Henares, Spain, 28805
Hospital Dr. Josep Trueta
Girona, Spain, 17007
Ukraine
Donetsk Regional Children Clinical Hospital
Donetsk, Ukraine, 83052
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, Ukraine, 76008
Ivano-Frankivsk State Regional Pediatric Clinical Hospital
Ivano-Frankivsk, Ukraine, 76014
Kharkiv Regional Clinical Children Hospital, Department of Endocrinology
Kharkiv, Ukraine, 61093
Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine
Kyiv, Ukraine, 04114
Ukrainian Children Specialized Clinical Hospital
Kyiv, Ukraine, 01135
Regional Clinical Endocrinology Dispensary of MoH Ukraine
Vinnitsa, Ukraine, 21010
United Kingdom
George Eliot Hospital NHS Trust
Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology,
Bristol, United Kingdom, BS1 3NY
Aintree University Hospitals NHS Foundation Trust
Liverpool, United Kingdom, L9 7AL
Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology
London, United Kingdom, SE1 9RT
Queens Medical Centre, Diabetes and Endocrinology Unit
Nottingham, United Kingdom, NG7 2UH
Sheffield Children's Hospital NHS Foundation Trust
Sheffield, United Kingdom, S10 2IH
Sponsors and Collaborators
MacroGenics
Eli Lilly and Company
Investigators
Study Director: Anastasia G Daifotis, MD MacroGenics
  More Information

Additional Information:
No publications provided

Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT00920582     History of Changes
Other Study ID Numbers: CP-MGA031-03
Study First Received: June 12, 2009
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MacroGenics:
Teplizumab
Protege
Protege Encore
MGA031
Monoclonal antibody
Type 1 Diabetes Mellitus
T1DM
MacroGenics
Recent Onset Diabetes
hOKT3γ1 (Ala-Ala)
Encore

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014