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:
MacroGenics
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
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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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920582
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| 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 May 16, 2013