TrialNet 14: Effects of Canakinumab on the Progression of Type 1 Diabetes in New Onset Subjects

Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody, designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine. In this phase II clinical trial, subjects were randomized to receive either monthly subcutaneous injections of 2.0 mg/kg canakinumab or placebo for 12 months. All subjects received standard intensive diabetes treatment with insulin and dietary management. Diabetes control was evaluated by measuring glycosylated hemoglobin (HbA1c) every three months. Insulin production was measured by a series of mixed meal glucose tolerance tests (MMTT) conducted regularly during the study. Subjects were followed for one year of treatment, plus one to three years of follow-up.