Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes (anti IL-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00947427
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

July 24, 2009
July 28, 2009
May 12, 2016
October 18, 2016
October 18, 2016
October 2010
April 2013   (Final data collection date for primary outcome measure)
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.
C-peptide response to MMTT at one year for subjects given canakinumab compared to placebo [ Time Frame: 3-4 years ]
Complete list of historical versions of study NCT00947427 on Archive Site
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The study will examine effects of canakinumab on immunological markers and metabolic outcomes. [ Time Frame: 3-4 years ]
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Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes
Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects

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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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Type 1 Diabetes
  • Preservation of Insulin Secretion
  • Newly Diagnosed Type 1 Diabetes
  • Canakinumab in Type 1 Diabetes
  • Drug: canakinumab (anti IL-1beta)
    canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
    Other Names:
    • canakinumab
    • anti IL-1beta
  • Drug: Placebo
    Placebo subcutaneous injections
  • Placebo Comparator: Placebo
    Placebo solution given by subcutaneous injection on monthly basis for 12 months
    Intervention: Drug: Placebo
  • Experimental: Canakinumab
    Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 12 months
    Intervention: Drug: canakinumab (anti IL-1beta)
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, Böehm B, Badenhoop K, Schloot N, Bak JF, Pozzilli P, Mauricio D, Donath MY, Castaño L, Wägner 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 45 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
TrialNet-cana (IND)
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP