Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes (TN14)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Preservation of Insulin Secretion; Type 1 Diabetes; Canakinumab in Type 1 Diabetes; Newly Diagnosed Type 1 Diabetes

Treatments: Drug: canakinumab (anti IL-1beta); Drug: Placebo

Study type: Interventional

Funder types: NIH

Identifiers

NCT00947427

TN14 Cana

UC4DK097835 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 6 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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71 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo solution given by subcutaneous injection on monthly basis for 12 months

Treatment:

Drug: Placebo

Canakinumab

Experimental group

Description:

Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 12 months

Treatment:

Drug: canakinumab (anti IL-1beta)