Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1 class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine. The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive standard intensive diabetes treatment with insulin and dietary management. Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12 injections over one year. All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up until study end. Enrollment is expected to occur over two years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
71
canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
Placebo subcutaneous injections
University of California-San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Yale Medical School
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Indiana University-Riley Hospital for Children
Indianapolis, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Columbia University
New York, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas-Southwestern Medical School
Dallas, Texas, United States
...and 2 more locations
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.
Time frame: 12 months
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