Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— TN14  

Official title:

Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947427
• Other study ID #: TN14 Cana
• Secondary ID: UC4DK097835
• Status: Completed
• Phase: Phase 2
• Start date: October 2010
• Est. completion date: April 2013

Study information

• Verified date: April 2020
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Canakinumab in Type 1 Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Newly Diagnosed Type 1 Diabetes
• Preservation of Insulin Secretion
• Type 1 Diabetes

Intervention

Drug:
• canakinumab (anti IL-1beta)
canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
• Placebo
Placebo subcutaneous injections

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
United States	University of Texas-Southwestern Medical School	Dallas	Texas
United States	University of Florida	Gainesville	Florida
United States	Indiana University-Riley Hospital for Children	Indianapolis	Indiana
United States	University of Miami School of Medicine	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale Medical School	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California-San Francisco	San Francisco	California
United States	Benaroya Research Institute	Seattle	Washington
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Moran A, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Greenbaum CJ, Herold KC, Marks JB, Raskin P, Sanda S, Schatz D, Wherrett DK, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet Canakinumab Study Group, Pickersgill L, de Koning E, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo	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.	12 months