Clinical Trial Details
| Trial ID: | L5474 |
| Source ID: | NCT00505375 |
| Associated Drug: | Ctla-4 Ig |
| Title: | Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus |
| Acronym: | TN09 |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00505375/results |
| Conditions: | Type 1 Diabetes Mellitus |
| Interventions: | DRUG: CTLA-4 Ig|OTHER: Placebo |
| Outcome Measures: | Primary: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 2 Year Visit, 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 of follow up | |
| 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|American Diabetes Association |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE2 |
| Enrollment: | 112 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2008-02 |
| Completion Date: | 2012-05 |
| Results First Posted: | 2016-08-16 |
| Last Update Posted: | 2020-05-06 |
| 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, United States|The Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States|University of Florida, Gainesville, Florida, 32610-0296, United States|University of Miami, Miami, Florida, 33136, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Columbia University, Naomi Berrie Diabetes Center, New York, New York, 10032, United States|University of Pittsburgh, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|University of Texas, Southwestern Medical School, Dallas, Texas, 75235-8858, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States|The Hospital for Sick Children, Toronto, Ontario, M5G-1X8, Canada |
| URL: | https://clinicaltrials.gov/show/NCT00505375 |
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