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Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes (TN14)

Primary Purpose

Type 1 Diabetes, Preservation of Insulin Secretion, Newly Diagnosed Type 1 Diabetes

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
canakinumab (anti IL-1beta)
Placebo
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring type 1 diabetes, newly diagnosed T1D, T1D, canakinumab, anti IL-1

Eligibility Criteria

6 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California-San Francisco
  • Stanford University
  • Yale Medical School
  • University of Florida
  • University of Miami School of Medicine
  • Indiana University-Riley Hospital for Children
  • University of Minnesota
  • Columbia University
  • University of Pittsburgh
  • University of Texas-Southwestern Medical School
  • Benaroya Research Institute
  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Canakinumab

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2009
Last Updated
April 27, 2020
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00947427
Brief Title
Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes
Acronym
TN14
Official Title
Effects of Canakinumab On The Progression of Type 1 Diabetes In New Onset Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo solution given by subcutaneous injection on monthly basis for 12 months
Arm Title
Canakinumab
Arm Type
Experimental
Arm Description
Subcutaneous injection of canakinumab at dose of 2.0 mg/kg given monthly of 12 months
Intervention Type
Drug
Intervention Name(s)
canakinumab (anti IL-1beta)
Other Intervention Name(s)
canakinumab, anti IL-1beta
Intervention Description
canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous injections
Primary Outcome Measure Information:
Title
C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of California-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Yale Medical School
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Indiana University-Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
57931
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas-Southwestern Medical School
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Benaroya Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available at the NIDDK Central Repository:https://repository.niddk.nih.gov/studies/tn14-anti-il-1-beta/?query=TN14
IPD Sharing URL
https://repository.niddk.nih.gov/studies/tn14-anti-il-1-beta/?query=TN14
Citations:
PubMed Identifier
23562090
Citation
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.
Results Reference
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Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes

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