Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes (anti IL-1)
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00947427
First received: July 24, 2009
Last updated: March 5, 2012
Last verified: March 2012
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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) |
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:
Genetics Home Reference related topics:
type 1 diabetes
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 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 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (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:
|
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
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
| Responsible Party: | Jay S. Skyler, MD, Type 1 Diabetes TrialNet Study Chair |
| ClinicalTrials.gov Identifier: | NCT00947427 History of Changes |
| Other Study ID Numbers: | TrialNet-cana (IND) |
| Study First Received: | July 24, 2009 |
| Last Updated: | March 5, 2012 |
| 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 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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013