Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes

Phase 2

Completed

• Conditions: Type 1 Diabetes; Preservation of Insulin Secretion; Canakinumab in Type 1 Diabetes; Newly Diagnosed Type 1 Diabetes
• Interventions: Drug: Placebo; Drug: canakinumab (anti IL-1beta)

• Registration Number: NCT00947427
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-28
• Study Start: 2010-10
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2016-05-12
• Results First Submitted QC: 2016-08-24
• Results First Posted: 2016-10-18
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo solution given by subcutaneous injection on monthly basis for 12 months
Canakinumab	canakinumab (anti IL-1beta)	Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 12 months

Primary Outcome Measures

Name	Time	Method
C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo	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.

Trial Locations

Locations (12)

University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Benaroya Research Institute; 🇺🇸 Seattle, Washington, United States

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

University of California-San Francisco; 🇺🇸 San Francisco, California, United States

Columbia University; 🇺🇸 New York, New York, United States

Yale Medical School; 🇺🇸 New Haven, Connecticut, United States

Stanford University; 🇺🇸 Stanford, California, 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