Conditions: Type 1 Diabetes Preservation of Insulin Secretion Newly Diagnosed Type 1 Diabetes Canakinumab in Type 1 Diabetes
Keywords: type 1 diabetes newly diagnosed T1D T1D canakinumab anti IL-1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 71
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Placebo solution given by subcutaneous injection on monthly basis for 12 months arm 2: Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 12 months

Interventions: intervention 1: canakinumab (anti IL-1beta) intervention 2: Placebo
Intervention descriptions: intervention 1: canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months intervention 2: Placebo subcutaneous injections

Protocol document: