Status:
COMPLETED
Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Preservation of Insulin Secretion
Eligibility:
All Genders
6-45 years
Phase:
PHASE2
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00947427
Start Date
October 1 2010
End Date
April 1 2013
Last Update
May 6 2020
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California-San Francisco
San Francisco, California, United States, 94143
2
Stanford University
Stanford, California, United States, 94305
3
Yale Medical School
New Haven, Connecticut, United States
4
University of Florida
Gainesville, Florida, United States, 32610-