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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00947427
First received: July 24, 2009
Last updated: May 28, 2013
Last verified: May 2013

July 24, 2009
May 28, 2013
October 2010
April 2013   (final data collection date for primary outcome measure)
C-peptide response to MMTT at one year for subjects given canakinumab compared to placebo [ Time Frame: 3-4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00947427 on ClinicalTrials.gov Archive Site
The study will examine effects of canakinumab on immunological markers and metabolic outcomes. [ Time Frame: 3-4 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Placebo Comparator: placebo injection
Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 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, Pociot F, Dinarello CA. 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
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
Both
6 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00947427
TrialNet-cana (IND)
Yes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
May 2013

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