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Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes (anti IL-1)
This study has been completed.
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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: August 24, 2016
Last verified: August 2016
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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) Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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:
Genetics Home Reference related topics:
type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
Drug Information available for:
Canakinumab
U.S. FDA Resources
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Primary Outcome Measures:
- 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.
| Enrollment: | 71 |
| 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
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:
|
Eligibility| 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
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
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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 |
| Results First Received: | May 12, 2016 |
| Last Updated: | August 24, 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:
|
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 |
ClinicalTrials.gov processed this record on August 16, 2017