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| Sponsor: | MacroGenics |
|---|---|
| Information provided by: | MacroGenics |
| ClinicalTrials.gov Identifier: | NCT00385697 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Drug: Teplizumab Other: Placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study |
| 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 |
| Enrollment: | 554 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Teplizumab
IV dosing daily for 14 days times 2 courses
|
| 2: Experimental |
Drug: Teplizumab
IV dosing daily for 14 days times 2 courses
|
| 3: Experimental |
Drug: Teplizumab
IV dosing daily for 14 days times 2 courses
|
| 4: Placebo Comparator |
Other: Placebo
IV dosing daily for 14 days times 2 courses
|
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
Eligibility| Ages Eligible for Study: | 8 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet all of the following criteria:
One positive result on testing for any of the following antibodies:
Subject must be in one of the following age groups:
Exclusion Criteria:
Subjects must have none of the following:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| UAB School of Medicine | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| NEA Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| Arkansas Children's Hospital | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| UCSF Medical Center | |
| San Francisco, California, United States, 94143 | |
| Diabetes Medical Center of California | |
| Northridge, California, United States, 91325 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| 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, Idaho | |
| Rocky Mountain Diabetes & Osteoporosis Center | |
| Idaho Falls, Idaho, United States, 83404 | |
| Humphrey Diabetes Center | |
| Boise, Idaho, United States, 87702 | |
| United States, Indiana | |
| Riley Hospital for Children | |
| 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, PA | |
| Wichita, Kansas, United States, 67211 | |
| United States, Kentucky | |
| Commonwealth Biomedical Research, LLC | |
| Madisonville, Kentucky, United States, 42431 | |
| 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 | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Alzohaili Medical Consultants | |
| Dearborne, Michigan, United States, 48126 | |
| United States, Missouri | |
| The Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Nebraska | |
| Creighton Diabetes Center | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| Saint Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| University of Medicine & Dentistry of NJ | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Joslin Diabetes Center | |
| Syracuse, New York, United States, 13214 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| St. Mary Medical Center | |
| Langhorne, Pennsylvania, United States, 19047 | |
| United States, South Carolina | |
| Sumter Medical Specialists | |
| Sumter, South Carolina, United States, 29150 | |
| United States, Tennessee | |
| University Diabetes & Endocrine Consultants | |
| Chattanooga, Tennessee, United States, 37403 | |
| Methodist Healthcare | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Research Institute of Dallas | |
| Dallas, Texas, United States, 75231 | |
| Diabetes and Glandular Disease Research | |
| San Antonio, Texas, United States, 78229 | |
| Spectra Research Center | |
| McAllen, Texas, United States, 78503 | |
| United States, Utah | |
| Endocrine Research Specialists | |
| Ogden, Utah, United States, 84403 | |
| United States, Washington | |
| Pacific Northwest Research Institute | |
| Seattle, Washington, United States, 98122 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Alberta | |
| Alberta Children's Hospital | |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Canada, Manitoba | |
| University of Manitoba | |
| Winnipeg, Manitoba, Canada, R3E0Z2 | |
| Canada, Newfoundland and Labrador | |
| University Health Sciences Centre | |
| St. John's, Newfoundland and Labrador, Canada, A1B3V6 | |
| Canada, Nova Scotia | |
| Capital District Health Authority | |
| Halifax, Nova Scotia, Canada, B3H2YN | |
| Canada, Ontario | |
| Oxford AIM Clinic | |
| London, Ontario, Canada, N6A 5R9 | |
| Children's Hospital of Western | |
| London, Ontario, Canada, N6A5W9 | |
| Czech Republic | |
| Nemocnice Jihlava | |
| Jihlava, Czech Republic, 58633 | |
| FN Kralovske Vinohrady | |
| Praha 10, Czech Republic, 10034 | |
| FN Hradec Kralove | |
| Hradec Kralove, Czech Republic, 50005 | |
| Fakultni nemocnice v Motole | |
| Praha, Czech Republic, 150 06 | |
| FN Brno- Detska nemocnice | |
| Brno, Czech Republic, 62500 | |
| Masarykova nemocnice v Usti nad Labem | |
| Usti nad Labem, Czech Republic, 40113 | |
| Estonia, Tallinn | |
| East Tallinn Central Hospital | |
| Ravi, Tallinn, Estonia, 10138 | |
| Estonia, Tartu | |
| Tartu University Hospital | |
| Puusepa, Tartu, Estonia, 51014 | |
| Germany | |
| Universitatsklinik Giessen | |
| Giessen, Germany, 35392 | |
| Charité-Hochschulmedizin Berlin | |
| Berlin, Germany, 12200 | |
| Germany, Baden-Wurttemberg | |
| Medizinische Universitätsklinik Ulm | |
| Ulm, Baden-Wurttemberg, Germany, 89070 | |
| Universitätsklinikum Heidelberg | |
| Heidelberg, Baden-Wurttemberg, Germany, 69120 | |
| Germany, North Rhine-Westphalia | |
| Herz-und Diabetszentrum Nordrhein-Westfalen | |
| Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545 | |
| India | |
| Pushpawati Singhania Research Institute | |
| New Delhi, India, 110017 | |
| Medwin Hospitals | |
| Hyderabad, India, 500001 | |
| India, Andhra Pradesh | |
| Nizam's Institute of Medical Sciences | |
| Hyderabad, Andhra Pradesh, India, 500082 | |
| King George Hospital | |
| Visakhapatnam, Andhra Pradesh, India, 530002 | |
| India, Gujarat | |
| Gujarat Endocrine Centre | |
| Ahmedabad, Gujarat, India, 380006 | |
| Medilink Research Centre | |
| Ahmedabad, Gujarat, India, 380015 | |
| India, Haryana | |
| Bharti Research Institute of Diabetes & Endocrinology | |
| Karnal, Haryana, India, 132001 | |
| India, Karnataka | |
| Bangalore Diabetes Centre | |
| Bangalore, Karnataka, India, 560043 | |
| India, Madhya Pradesh | |
| Diabetes Thyroid Hormone Research Institute PVT LTD | |
| Indore, Madhya Pradesh, India, 452001 | |
| India, Maharashtra | |
| Gandhi Endocrinology and Diabetes Centre | |
| Nagpur, Maharashtra, India, 440010 | |
| Grant Medical Foundation | |
| Pune, Maharashtra, India, 411001 | |
| Mediheights Pvt Ltd | |
| Mumbai, Maharashtra, India, 400067 | |
| Endocrine Clinic | |
| Nasik, Maharashtra, India, 422013 | |
| India, Rajasthan | |
| Fortis Escorts Hospital | |
| Jaipur, Rajasthan, India, 302017 | |
| India, West Bengal | |
| B.P.Poddar Hospital and Medical Research Ltd | |
| Kolkata, West Bengal, India, 700053 | |
| Israel | |
| Wolfson Medical Centre | |
| Holon, Israel, 58100 | |
| Soroka Medical Centre | |
| Beer Sheba, Israel, 84101 | |
| National Centre for Childhood and Diabetes | |
| Petach Tikva, Israel, 49202 | |
| Rambam Medical Centre | |
| Haifa, Israel, 31096 | |
| Hillel Yaffe Medical Center | |
| Hadera, Israel, 38100 | |
| Chaim Sheba Medical Center | |
| Ramat-Gan, Israel, 56261 | |
| Latvia | |
| P. Stradins Clinical University Hospital | |
| Riga, Latvia, 1002 | |
| Mexico | |
| Hospital Mexico-Americano | |
| Guadalajara, Mexico, 44620 | |
| Hospital General de Mexico | |
| Mexico City, Mexico, 06726 | |
| Hospital Central | |
| San Luis Potosí, Mexico, 78240 | |
| Mexico, Nuevo Leon | |
| Hospital CIMA Santa Engracia | |
| San Pedro Garza García, Nuevo Leon, Mexico, 66260 | |
| Netherlands | |
| Diabeter Center for Pediatric and Adolescent Diabetes Care and Research | |
| Rotterdam, Netherlands, 3011TG | |
| Poland | |
| Powiatowy Zespot Szpitali w Olesnicy, Oddzial Chorob Wewnetrznych | |
| Olesnica, Poland, 56400 | |
| Samodzielny Publiczny Szpital Kliniczny Akademi Medycznej w Bialymstoku | |
| Bialystok, Poland, 15-276 | |
| I. Szpital Miejski im. Dr. E. Sonnenberga w Lodzi | |
| Kodz, Poland, 92115 | |
| Wojewodzki Specjalistyczny Szpital Dzieciecy | |
| Kielce, Poland, 25-734 | |
| Uniwersytecki Szpital Kliniczny | |
| Lodz, Poland, 91-738 | |
| Klinika Endokrynologii i Diabetologii Wieku Rozwojowego | |
| Wroclaw, Poland, 51-376 | |
| Oddzial Diabetologiczny Klinika Pediatrii | |
| Gdansk, Poland, 80-952 | |
| Romania | |
| Centrul Medical "Sanatatea ta" | |
| Bucuresti, Romania, 20725 | |
| S.C. Minimed S.R.L. | |
| Bacau, Romania, 600164 | |
| Spitalul Judetean Satu Mare | |
| Satu Mare, Romania, 440055 | |
| Spitulul Clinic Judetean de Urgenta Cluj | |
| Cluj-Napoca, Romania, 400006 | |
| Spitalul Clinic Judetean de Urgenta | |
| Iasi, Romania, 700111 | |
| Institutul de Diabet | |
| Bucharest, Romania, 020045 | |
| Spain | |
| Hospital Clinic I Provincial | |
| Barcelona, Spain, 8036 | |
| Hospital Germans Trias i Pujol | |
| Badalona, Spain, 8916 | |
| Fundacion Jimenez Diaz | |
| Madrid, Spain, 28040 | |
| Spain, Gerona | |
| Hospital Universitari Dr. Josep Trueta de Girona | |
| Girona, Gerona, Spain, 17007 | |
| Spain, Madrid | |
| Hospital Universitario Principe de Asturias | |
| Alcala de Henares, Madrid, Spain, 28805 | |
| Sweden | |
| Universitetssjukhuset i Lund | |
| Lund, Sweden, 22185 | |
| Sodersjukhuset AB | |
| Stockholm, Sweden, 11883 | |
| Universitetssjukhuset i Linkoping | |
| Linkoping, Sweden, 58185 | |
| Universitetssjukhuset i Linkoping | |
| Linkoping, Sweden, 58185 | |
| Ukraine | |
| Ukranian Children Specialised Clinical Hospital | |
| Kyiv, Ukraine, 02175 | |
| Donetsk Regional Children Clinical Hospital | |
| Donetsk, Ukraine, 83052 | |
| Ukrainian Scientific and Practical Center of Endocrine Surgery | |
| Kyiv, Ukraine, 02175 | |
| V. Danilevsky Institute of Endocrine Pathology Problems | |
| Kharkiv, Ukraine, 61070 | |
| Regional Clinical Endocrinological Dispensary | |
| Vinnitsa, Ukraine, 21010 | |
| Zaporizhzhya Regional Pediatric Hospital | |
| Zaporizhzhya, Ukraine, 69035 | |
| Kharkiv Regional Clinical Children's Hospital | |
| Kharkiv, Ukraine, 61093 | |
| United Kingdom, Cambridgeshire | |
| Addenbrookes Hospital | |
| Cambridge, Cambridgeshire, United Kingdom, CB20QQ | |
| United Kingdom, Devon | |
| Royal Devon and Exeter Hospital | |
| Exeter, Devon, United Kingdom, EX25DW | |
More Information
| Responsible Party: | MacroGenics, Inc. ( Stanley R. Pillimer, MD/ Vice President Clinical Research and Product Safety ) |
| Study ID Numbers: | CP-MGA031-01 |
| Study First Received: | October 7, 2006 |
| Last Updated: | August 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00385697 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Randomized Double Blind Parallel Group Controlled Clinical Trial |
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