Phase 2
Completed N=71
Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes
Type 1 Diabetes · Preservation of Insulin Secretion · Newly Diagnosed Type 1 Diabetes · Canakinumab in Type 1 Diabetes
Source: ClinicalTrials.gov NCT00947427 ↗
Enrolled (actual)
71
Serious AEs
2.8%
Results posted
Oct 2016
Primary outcomePrimary: C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo — 0.40; 0.41 nmol/L — p=0.86
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo |
0.40; 0.41 | 0.86 |
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
Data sourced from ClinicalTrials.gov (NCT00947427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.