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
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Preservation of Insulin Secretion
Newly Diagnosed Type 1 Diabetes
Canakinumab in Type 1 Diabetes
Drug: canakinumab (anti IL-1beta)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The study will examine effects of canakinumab on immunological markers and metabolic outcomes. [ Time Frame: 3-4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: October 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo injection
Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
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

  Eligibility

Ages Eligible for Study:   6 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947427

Locations
United States, California
University of California-San Francisco
San Francisco, California, United States, 94143
Stanford University
Stanford, California, United States, 94305
United States, Connecticut
Yale Medical School
New Haven, Connecticut, United States
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610-
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Indiana
Indiana University-Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 57931
United States, New York
Columbia University
New York, New York, United States
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas-Southwestern Medical School
Dallas, Texas, United States, 75235
United States, Washington
Benaroya Research Institute
Seattle, Washington, United States, 98101
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00947427     History of Changes
Other Study ID Numbers: TrialNet-cana (IND)
Study First Received: July 24, 2009
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
type 1 diabetes
newly diagnosed T1D
T1D
canakinumab
anti IL-1

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014