Clinical Trial Details
| Trial ID: | L1906 |
| Source ID: | NCT00419562 |
| Associated Drug: | Oral Insulin |
| Title: | Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus |
| Acronym: | TN07 |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00419562/results |
| Conditions: | Diabetes Mellitus, Type 1 |
| Interventions: | DRUG: Oral Insulin|DRUG: Placebo |
| Outcome Measures: | Primary: Rate of Type 1 Diabetes Per Year Among Individuals in the Primary Stratum When Treated With Oral Inulin Versus Placebo, Primary outcome is reported as the rate of type 1 diabetes per year among the primary stratum; type 1 diabetes was diagnosed based on metabolic testing and assessment of symptoms. This is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up., Metabolic and immunological tests were conducted every 6 months; participants were followed for a median of 2.7 years | Secondary: Rate of Type 1 Diabetes Per Year in Secondary Stratum (Stratum 2) When Treated With Oral Insulin Versus Placebo, Secondary outcome is reported as the rate of type 1 diabetes per year among secondary stratum 2; type 1 diabetes was diagnosed based on metabolic testing and assessment of symptoms. This is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up., Metabolic and immunological tests were conducted every 6 months; participants were followed for a median of 2.7 years|Rate of Type 1 Diabetes in Secondary Stratum (Stratum 3+4) When Treated With Oral Insulin Versus Placebo, Secondary outcome is reported as the rate of type 1 diabetes per year among secondary stratum 3+4; type 1 diabetes was diagnosed based on metabolic testing and assessment of symptoms. This is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up., Metabolic and immunological tests were conducted every 6 months; participants were followed for a median of 2.7 years |
| Sponsor/Collaborators: | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|National Institute of Allergy and Infectious Diseases (NIAID)|National Center for Research Resources (NCRR)|American Diabetes Association|Juvenile Diabetes Research Foundation |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE3 |
| Enrollment: | 560 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION |
| Start Date: | 2007-02 |
| Completion Date: | 2017-06 |
| Results First Posted: | 2020-02-18 |
| Last Update Posted: | 2020-05-07 |
| Locations: | University of California-San Francisco, San Francisco, California, 94143, United States|Stanford University, Stanford, California, 94305, United States|Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80010, United States|Yale University, New Haven, Connecticut, 06520, United States|University of Florida, Gainesville, Florida, 32610-0296, United States|University of Miami, Miami, Florida, 33136, United States|Indiana University-Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Columbia University, New York, New York, 10032, United States|Childrens Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|Vanderbilt Eskind Diabetes Clinic, Nashville, Tennessee, 37232-8160, United States|University of Texas, Dallas, Texas, 75235-8858, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States|Walter and Eliza Hall Institute, Parkville, Victoria, 3050, Australia|The Hospital for Sick Children, Toronto, Ontario, M5G1X8, Canada|University of Turku, Turku, FIN-20520, Finland|San Raffaele Hospital, Milan, 20132, Italy|University of Bristol, Bristol, BS10 5NB, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00419562 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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