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.

The primary objective was to assess the safety, efficacy, and mode of action of canakinumab injections for the treatment of individuals with new onset type 1 diabetes.

The primary outcome measure was baseline adjusted c-peptide response to MMTT at one year for subjects given canakinumab compared to placebo. Secondary outcome measures included immunological markers and metabolic outcomes.

Eligible subjects were 6 to 45 years old with an insulin dependent type 1 diabetes mellitus diagnosis within the previous 100 days. Additional criteria included the presence of at least one diabetes related autoantibody, stimulated C-peptide levels of at least 0.2 pmol/ml as assessed by a MMTT, at least one month since last live immunization, and willingness to forgo live vaccines for 24 months.

The difference between the two groups in the c-peptide response at one year was not significant. Similarly, there was no difference in insulin dose at 1 year between groups. Canakinumab was found to be safe but not effective as a single immunomodulatory drug in recent-onset type 1 diabetes.