Clinical Trial Details
| Trial ID: | L7340 |
| Source ID: | NCT02580877 |
| Associated Drug: | 67.5 Mg Oral Insulin Crystals Daily |
| Title: | Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02580877/results |
| Conditions: | Type 1 Diabetes |
| Interventions: | DRUG: 67.5 mg oral insulin crystals daily|DRUG: 500mg oral insulin crystals every other week |
| Outcome Measures: | Primary: Change in GAD65 Autoantibody Titer (DK Units/mL), Change in T-lymphocyte (GAD65) biomarker of beta cell specific immune response, 13 and 26 weeks after first dose versus baseline|Change in mIAA Autoantibody Titer From Baseline, Micro-islet autoantibodies (mIAA) autoantibody titers are a measure of of beta cell immune response, 13 and 26 weeks after first dose versus baseline | |
| Sponsor/Collaborators: | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Collaborators: Type 1 Diabetes TrialNet |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE2 |
| Enrollment: | 92 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION |
| Start Date: | 2016-01 |
| Completion Date: | 2018-03 |
| Results First Posted: | 2020-07-27 |
| Last Update Posted: | 2020-07-27 |
| Locations: | University of California - San Francisco, San Francisco, California, 94158-2549, United States|Stanford University, Stanford, California, 94305, United States|Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80109, 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|Emory Children's Center, Atlanta, Georgia, 30322, United States|University of Chicago, Chicago, Illinois, 60637, United States|Indiana University-Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|Columbia University-Naomi Berrie Diabetes Center, New York, New York, 10032, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States|Vanderbilt University, Nashville, Tennessee, 37232, United States|University of Texas Southwestern, Dallas, Texas, 75390, United States|Baylor College of Medicine, Houston, Texas, 77030, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States|Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, 3050, Australia|The Hospital for Sick Children, Toronto, Ontario, Canada|San Raffaele Hospital, Milan, Italy |
| URL: | https://clinicaltrials.gov/show/NCT02580877 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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