Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes
Condition: Type 1 Diabetes; Preservation of Insulin Secretion; Newly Diagnosed Type 1 Diabetes; Canakinumab in Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: canakinumab (anti IL-1beta); Placebo
Intervention description: canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months; Placebo subcutaneous injections
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 6 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: type 1 diabetes; newly diagnosed T1D; T1D; canakinumab; anti IL-1

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the ages of 6-45 years

          -  Be within 3-months (100 days) of diagnosis of type 1 diabetes

          -  Must have at least one diabetes-related autoantibody present

          -  Must have stimulated C-peptide levels >0.2 pmol/ml measured during a mixed meal
             tolerance test (MMTT) conducted at least 21 days from diagnosis and within 37 days of
             randomization

          -  If participant is female with reproductive potential, she must be willing to avoid
             pregnancy and have a negative pregnancy test during the 12 months of treatment and for
             an additional 3 months after completing treatment

          -  Be at least one month from time of last live immunization received

          -  Willing to forgo live vaccinations for 24 months

          -  Must be willing to comply with intensive diabetes management

          -  Must weigh at least 20 kg (44 lbs) at study entry

        Exclusion Criteria:

          -  Are immunodeficient or have clinically significant chronic lymphopenia (low white
             blood cell count)

          -  Have an active infection

          -  Have a positive PPD test result

          -  Be currently pregnant or lactating, or anticipate getting pregnant

          -  Ongoing use of medications known to influence glucose tolerance

          -  Require use of other immunosuppressive agents

          -  Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C infection

          -  Have any complicating medical issues or abnormal clinical laboratory blood counts or
             results that interfere with study conduct; history of malignancies

          -  Be currently participating in another type 1 diabetes treatment study