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

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ClinicalTrials.gov Identifier: NCT00947427
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects
Study Start Date : October 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Canakinumab

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo solution given by subcutaneous injection on monthly basis for 12 months
 Drug: Placebo
Placebo subcutaneous injections
Experimental: Canakinumab
Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947427


Locations
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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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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)
First Posted: July 28, 2009    Key Record Dates
Results First Posted: October 18, 2016
Last Update Posted: October 18, 2016
Last Verified: August 2016
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:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs