Clinical trial NCT00947427: Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes
Official title: Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Preservation of Insulin Secretion
Newly Diagnosed Type 1 Diabetes
Canakinumab in Type 1 Diabetes
Keywords: type 1 diabetes
newly diagnosed T1D
T1D
canakinumab
anti IL-1
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2009-07-28
Enrollment: 71
Sex: ALL
Minimum age (years): 6
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California-San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale Medical School
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Indianapolis
country: United States
facility: Indiana University-Riley Hospital for Children
state: Indiana
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Columbia University
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas-Southwestern Medical School
state: Texas
city: Seattle
country: United States
facility: Benaroya Research Institute
state: Washington
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
References:
citation: Moran A, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Greenbaum CJ, Herold KC, Marks JB, Raskin P, Sanda S, Schatz D, Wherrett DK, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet Canakinumab Study Group; Pickersgill L, de Koning E, Ziegler AG, Boehm B, Badenhoop K, Schloot N, Bak JF, Pozzilli P, Mauricio D, Donath MY, Castano L, Wagner A, Lervang HH, Perrild H, Mandrup-Poulsen T; AIDA Study Group. Interleukin-1 antagonism in type 1 diabetes of recent onset: two multicentre, randomised, double-blind, placebo-controlled trials. Lancet. 2013 Jun 1;381(9881):1905-15. doi: 10.1016/S0140-6736(13)60023-9. Epub 2013 Apr 5.