| Outcome Measures: |
Primary: C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo, 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., 12 months |
|
| Locations: |
University of California-San Francisco, San Francisco, California, 94143, United States|Stanford University, Stanford, California, 94305, United States|Yale Medical School, New Haven, Connecticut, United States|University of Florida, Gainesville, Florida, 32610-, United States|University of Miami School of Medicine, Miami, Florida, 33136, United States|Indiana University-Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|University of Minnesota, Minneapolis, Minnesota, 57931, United States|Columbia University, New York, New York, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|University of Texas-Southwestern Medical School, Dallas, Texas, 75235, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States|Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada
|
