Type 1 Diabetes Mellitus Clinical Trial
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
Verified date | October 2023 |
Source | MacroGenics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 254 |
Est. completion date | July 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 35 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques du Sud Luxembourg - Vivalia | Arlon | |
Belgium | Universitair Ziekenhuis Antwerpen | Edegem | Antwerp |
Czechia | I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice | Brno | |
Czechia | Centrum diabetologie, Institut klinicke a experimentalni mediciny | Praha | |
Czechia | Klinika deti a dorostu FN Kralovske Vinohrady | Praha | |
Czechia | Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole | Praha | |
Czechia | Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z. | Usti nad Labem | |
Finland | Kuopio University Hospital | Kuopio | |
Finland | Central Hospital of Mikkeli | Mikkeli | |
Finland | Oulu University Hospital | Oulu | |
France | CHU de Besançon | Besançon | |
France | CHU de Brest Hôpital de la Cavale Blanche | Brest | |
France | Centre Hospitalier Sud Francilien | Corbeil-Essonnes | |
France | CHU de Bordeaux | Pessac | |
France | CHU de Reims | Reims | |
France | Hôpitaux Universitaires de Strasbourg Hôpital Civil | Strasbourg | |
Germany | Diabetes-Klinik Bad Nauheim GmbH | Bad Nauheim | |
Germany | Herz und Diabeteszentrum Nordrhein-Westfallen | Bad Oeynhausen | |
Germany | Charite, Campus Benjamin Franklin | Berlin | |
Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
Germany | Universitatsklinik Giessen | Giessen | |
Germany | Asklepios Westklinikum Hamburg | Hamburg | |
Germany | Kinderkrankenhaus auf der Bult | Hannover | |
Germany | Universitatsklinikum Heidelberg | Heidelberg | |
India | DHL Research Centre | Ahmedabad | Gujarat |
India | Bangalore Diabetes Centre | Bangalore | Karnataka |
India | Kalinga Hospital Limited | Bhubaneswar | Orissa |
India | Hormone Care & Research Center | Ghaziabad | Uttar Pradesh |
India | Medwin Hospitals | Hyderabad | Andhra Pradesh |
India | Fortis Escorts Hospital | Jaipur | Rajasthan |
India | Apollo Glenagles Hospital | Kolkata | West Bengal |
India | B. P. Poddar Hospital & Medical Research Limited | Kolkata | West Bengal |
India | Dayanand Medical College and Hospital | Ludhiana | Punjab |
India | Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd. | Madhya | Pradesh |
India | Gandhi's Research Institute | Nagpur | Maharashtra |
India | Maulana Azad Medical College and Associated Hospitals | New Delhi | Delhi |
India | Grant Medical Foundation | Pune | Maharashtra |
India | KEM Hospital Research Center | Pune | Maharashtra |
India | Health & Research Centre | Trivandrum | Kerala |
India | King George Hospital | Visakhapatnam | Andhra Pradesh |
Israel | Hillel Yaffe Medical Center | Hadera | |
Israel | Mayer Children's Hospital of Haifa | Haifa | |
Israel | The E. Wolfson Medical Center | Holon | |
Israel | Schneider Children's Medical | Petach-Tikva | |
Israel | The Safra Children's Hospital, The Chaim Sheba Medical Center | Ramat-Gan | |
Italy | Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena, | Modena | |
Italy | U.O. di Malattie del Metabolismo | Pisa | |
Italy | U.O. di Malattie Metaboliche e Diabetologia | Pisa | |
Mexico | Medical Care & Research | Merida | Yucatan |
Mexico | Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C. | Mexico, Distrito Federal | |
Mexico | Hospital y Clinica OCA / Monterrey International Research Center | Monterrey | Nuevo León |
Netherlands | Stichting Diabeter | Rotterdam | |
Poland | Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | |
Poland | Uniwersyteckie Centrum Kliniczne | Gdansk | |
Poland | Wojewódzki Specjalistyczny Szpital Dzieciecy | Kielce | |
Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4 | Lódz | |
Poland | Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia | Warszawa | |
Poland | Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu | Wroclaw | |
Romania | S.C. Minimed S.R.L. | Bacau | |
Romania | Institutul National De Diabet, Nutritie si Boli Metabolice | Bucuresti | |
Romania | Spitalul Judetean de Urgenta Satu Mare | Satu-Mare | |
Spain | Hospital Universitario Principe de Asturias | Alcala de Henares | |
Spain | Hospital Dr. Josep Trueta | Girona | |
Ukraine | Donetsk Regional Children Clinical Hospital | Donetsk | |
Ukraine | Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | |
Ukraine | Ivano-Frankivsk State Regional Pediatric Clinical Hospital | Ivano-Frankivsk | |
Ukraine | Kharkiv Regional Clinical Children Hospital, Department of Endocrinology | Kharkiv | |
Ukraine | Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine | Kyiv | |
Ukraine | Ukrainian Children Specialized Clinical Hospital | Kyiv | |
Ukraine | Regional Clinical Endocrinology Dispensary of MoH Ukraine | Vinnitsa | |
United Kingdom | University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology, | Bristol | |
United Kingdom | Aintree University Hospitals NHS Foundation Trust | Liverpool | |
United Kingdom | Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology | London | |
United Kingdom | Queens Medical Centre, Diabetes and Endocrinology Unit | Nottingham | |
United Kingdom | George Eliot Hospital NHS Trust | Nuneaton | Warwickshire |
United Kingdom | Sheffield Children's Hospital NHS Foundation Trust | Sheffield | |
United States | Albany Medical College | Albany | New York |
United States | Atlanta Diabetes Associates | Atlanta | Georgia |
United States | St. Agnes Hospital | Baltimore | Maryland |
United States | AM Diabetes & Endocrinology Center | Bartlett | Tennessee |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University Diabetes & Endocrine Consultants | Chattanooga | Tennessee |
United States | John H Stoger Jr. Hospital of Cook County, Cook County Hospital | Chicago | Illinois |
United States | University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology | Columbia | Missouri |
United States | Bassett Healthcare | Cooperstown | New York |
United States | Clinical Innovations Inc. Research Facility | Costa Mesa | California |
United States | Research Institute of Dallas | Dallas | Texas |
United States | Alzohaili Medical Consultants | Dearborn | Michigan |
United States | East Carolina University, Brody School of Medicine | Greenville | North Carolina |
United States | GHS Pediatric Endocrinology | Greenville | South Carolina |
United States | Houston Center for Clinical Research | Houston | Texas |
United States | Southwest Clinical Trials | Houston | Texas |
United States | Indiana University School of Medicine | Indianapolis | Indiana |
United States | University of Iowa Children's Hospital | Iowa City | Iowa |
United States | Medical & Surgical Clinic of Irving | Irving | Texas |
United States | NEA Clinic | Jonesboro | Arkansas |
United States | The Children's Mercy Hospital | Kansas City | Missouri |
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
United States | Saint Barnabas Medical Center | Livingston | New Jersey |
United States | Axis Clinical Trials | Los Angeles | California |
United States | LeBonheur Children's Medical Center | Memphis | Tennessee |
United States | Yale University | New Haven | Connecticut |
United States | Christiana Care Research Institute | Newark | Delaware |
United States | Endocrine Research Specialists | Ogden | Utah |
United States | Diabetes Associates Medical Group, Inc | Orange | California |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism | Richmond | Virginia |
United States | Clinical Innovations, Inc. | Riverside | California |
United States | Maryland Diabetes & Endocrine Associates | Rockville | Maryland |
United States | Children's Hospitals and Clinics of Minnesota | Saint Paul | Minnesota |
United States | Diabetes and Glandular Disease Research Associates, PA | San Antonio | Texas |
United States | InVisions Consultants, LLC | San Antonio | Texas |
United States | San Diego Clinical Trials | San Diego | California |
United States | University of Washington | Seattle | Washington |
United States | Ronald Chochinov Md Inc | Ventura | California |
United States | Richard Hays, MD | Wellington | Florida |
United States | Mid-America Diabetes Associates | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
MacroGenics | Eli Lilly and Company |
United States, Belgium, Czechia, Finland, France, Germany, India, Israel, Italy, Mexico, Netherlands, Poland, Romania, Spain, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Subjects With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | 52 weeks after randomization | ||
Primary | Mean Change From Baseline in HbA1c Between Teplizumab and Placebo | 52 weeks after randomization | ||
Secondary | The Change in Beta-cell Function as Measured by C-peptide Secretory Response Following a Mixed Meal | 52 weeks after randomization | ||
Secondary | The Change in Beta-cell Function as Measured by C-peptide Secretory Response Following a Mixed Meal | 104 weeks after randomization | ||
Secondary | Mean Number of Total, Major, Minor and Nocturnal Hypoglycemia Events | Number of hypoglycemic events by type per participant | Throughout the study up to 2 years | |
Secondary | Mean Number of Daily Insulin Injections | 52 weeks after randomization | ||
Secondary | Number of Subjects With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | 104 weeks after randomization | ||
Secondary | The Proportion of Subjects Who Have Both a Total Daily Insulin Dose < 0.5 U/Kg/Day and Hemoglobin A1c (HbA1c) Level < 7.0% | 52 weeks after randomization | ||
Secondary | The Mean HbA1c Change From Baseline | 104 weeks after randomization | ||
Secondary | Number of Participants With Adverse Events | throughout the study, up to 104 weeks | ||
Secondary | Number of Participants With Serious Adverse Events | throughout the study, up to 104 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
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