Clinical Trial Details
| Trial ID: | L7067 |
| Source ID: | NCT00279305 |
| Associated Drug: | Anti-Cd20 (Rituximab) |
| Title: | Rituximab in New Onset Type 1 Diabetes |
| Acronym: | TN05 |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00279305/results |
| Conditions: | Type 1 Diabetes Mellitus |
| Interventions: | DRUG: Anti-CD20 (rituximab)|DRUG: Placebo Comparator |
| Outcome Measures: | Primary: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year, 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. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the "AUC mean" and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis., When all participants complete the 1 year visit | |
| 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)|American Diabetes Association|Juvenile Diabetes Research Foundation |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE2 |
| Enrollment: | 87 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2005-08 |
| Completion Date: | 2009-11 |
| Results First Posted: | 2016-08-18 |
| Last Update Posted: | 2020-05-06 |
| Locations: | Childrens Hospital of 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|Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80010, 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|Joslin, Boston, Massachusetts, 02215, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Columbia University, New York, New York, 10032, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|University of Texas, Dallas, Texas, 75235-8858, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States|Walter and Eliza Hall Institute of Medical Research, Victoria, Australia|The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada|San Raffaele Hospital, Milan, Italy |
| URL: | https://clinicaltrials.gov/show/NCT00279305 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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