Clinical Trial Details
| Trial ID: | L6459 |
| Source ID: | NCT01030861 |
| Associated Drug: | Teplizumab |
| Title: | Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk" |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01030861/results |
| Conditions: | Autoantibody Positive|Non-diabetic Relatives at Risk for Type 1 Diabetes|High Risk|Impaired Glucose Tolerance |
| Interventions: | DRUG: Teplizumab|DRUG: Placebo infusion |
| Outcome Measures: | Primary: Rate of New Diabetes Per Year, Rate at which criteria are met for diabetes onset as defined by the American Diabetes Association (ADA) based on glucose testing or the presence of unequivocal hyperglycemia with acute metabolic decompensation., During follow-up, median 745 days, range 74 to 2683 | Secondary: Number of Participants With Adverse Events, Adverse events categorized and graded via CTCAE., Baseline Visit to Diagnosis of Type 1 Diabetes median 745 days, range 74 to 2683 |
| Sponsor/Collaborators: | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|National Center for Research Resources (NCRR)|Juvenile Diabetes Research Foundation|American Diabetes Association |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE2 |
| Enrollment: | 76 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2010-08 |
| Completion Date: | 2019-06 |
| Results First Posted: | 2020-08-05 |
| Last Update Posted: | 2020-08-05 |
| Locations: | University of California in San Francisco, San Francisco, California, 94143, United States|University of California-San Francisco, San Francisco, California, 94143, United States|Stanford University, Stanford, California, 94305, United States|Barbara Davis Center for Childhood Diabetes/ University of Colorado, Denver, Colorado, 80045, United States|Yale University School of Medicine, New Haven, Connecticut, 06519, United States|University of Florida, Gainesville, Florida, 32610, United States|University of Miami, Miami, Florida, 33136, United States|University of South Florida, Tampa, Florida, 33612, United States|Indiana University, Indianapolis, Indiana, 46202, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|The Children's Mercy Hospital, Kansas City, Missouri, 64108, United States|Columbia University, New York, New York, 10032, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15201, United States|Vanderbilt University, Nashville, Tennessee, 37232, United States|University of Texas, Dallas, Texas, 75390-9072, United States|Baylor College of Medicine, Houston, Texas, 77030, United States|Benaroya Research Institute, Seattle, Washington, 982101, United States|The Hospital for Sick Children, Toronto, Ontario, MSG-1X8, Canada|Forschergruppe Diabetes, Munich, Germany |
| URL: | https://clinicaltrials.gov/show/NCT01030861 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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