Clinical Trial Details
| Trial ID: | L6547 |
| Source ID: | NCT00100178 |
| Associated Drug: | Mycophenolate Mofeteil (Mmf) |
| Title: | New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial |
| Acronym: | TN02 |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00100178/results |
| Conditions: | Diabetes Mellitus, Type 1 |
| Interventions: | DRUG: Mycophenolate mofeteil (MMF)|DRUG: Daclizumab (DZB)|DRUG: Placebo control for Mycophenolate mofeteil (MMF)|DRUG: Placebo control for Daclizumab (DZB) |
| Outcome Measures: | Primary: Mean Stimulated C-peptide Area Under the Curve, The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes., 2 years | |
| 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)|Juvenile Diabetes Research Foundation|National Center for Research Resources (NCRR) |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE2 |
| Enrollment: | 126 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER |
| Start Date: | 2004-05 |
| Completion Date: | 2008-04 |
| Results First Posted: | 2016-08-16 |
| Last Update Posted: | 2020-05-05 |
| Locations: | Childrens Hospital Los Angeles, Los Angeles, California, 90027, United States|University of California-San Francisco, San Francisco, California, 94143, United States|Stanford University, Stanford, California, 94305-5208, United States|Barbara Davis Center for Childhood Diabetes, University of Colorado, Denver, Colorado, 80262, United States|University of Florida, Gainesville, Florida, 32610, United States|Indiana University, Indianapolis, Indiana, 46202, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Columbia University, New York, New York, 10032, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States|Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada |
| URL: | https://clinicaltrials.gov/show/NCT00100178 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|