Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Canakinumab in Type 1 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Newly Diagnosed Type 1 Diabetes Nutritional and Metabolic Diseases Preservation of Insulin Secretion

Age range

6 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital for Sick Children, Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

canakinumab (anti IL-1beta)

Drug

canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months

Other names: canakinumab, anti IL-1beta

Placebo

Drug

Placebo subcutaneous injections

Primary outcomes

C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo

Time frame: 12 months

The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the "AUC mean" and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

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

Acronym: TN14

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jul 28, 2009
Registry last updated: May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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