Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes

Completed · Phase 2 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT00947427

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

71

Starts

2010-10-01

Expected to finish

2013-04-01

Last updated by the study team

2020-05-06

Who can join

Age: 6 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California-San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Yale Medical School — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Indiana University-Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Columbia University — New York, New York, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas-Southwestern Medical School — Dallas, Texas, United States
• Benaroya Research Institute — Seattle, Washington, United States
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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