NCT00947427

Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes

Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 6 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes
• Preservation of Insulin Secretion
• Newly Diagnosed Type 1 Diabetes
• Canakinumab in Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	canakinumab (anti IL-1beta)	canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
DRUG	Placebo	Placebo subcutaneous injections

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2009-07-28
• Last updated: 2020-05-06
• Results posted: 2016-10-18

Locations

12 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study