Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes

NCT00947427 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: TN14 CanaUC4DK097835
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 12

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.

Conditions

Type 1 Diabetes; Preservation of Insulin Secretion; Newly Diagnosed Type 1 Diabetes; Canakinumab in Type 1 Diabetes

Keywords

type 1 diabetes; newly diagnosed T1D; T1D; canakinumab; anti IL-1

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo solution given by subcutaneous injection on monthly basis for 12 months

Drug: Placebo

Canakinumab

EXPERIMENTAL

Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 12 months

Drug: canakinumab (anti IL-1beta)

Interventions

canakinumab (anti IL-1beta) DRUG

canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months

Also known as: canakinumab, anti IL-1beta

Canakinumab

Placebo DRUG

Placebo subcutaneous injections

Placebo

Eligibility Criteria

• Age: 6 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (12)

University of California-San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Yale Medical School

New Haven, Connecticut, United States

Location

University of Florida

Gainesville, Florida, 32610-, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Indiana University-Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 57931, United States

Location

Columbia University

New York, New York, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas-Southwestern Medical School

Dallas, Texas, 75235, United States

Location

Benaroya Research Institute

Seattle, Washington, 98101, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related 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, Ziegler AG, Boehm B, Badenhoop K, Schloot N, Bak JF, Pozzilli P, Mauricio D, Donath MY, Castano L, Wagner A, Lervang HH, Perrild H, Mandrup-Poulsen T; AIDA Study Group. Interleukin-1 antagonism in type 1 diabetes of recent onset: two multicentre, randomised, double-blind, placebo-controlled trials. Lancet. 2013 Jun 1;381(9881):1905-15. doi: 10.1016/S0140-6736(13)60023-9. Epub 2013 Apr 5.

  PMID: 23562090 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Carla Greenbaum
• Organization: Benaroya Research Institute

cjgreen@benaroyaresearch.org

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2009
• First Posted: July 28, 2009
• Study Start: October 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 6, 2020
• Results First Posted: October 18, 2016

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (11); CA (1)