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Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes (anti IL-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00947427
First received: July 24, 2009
Last updated: August 24, 2016
Last verified: August 2016
Results First Received: May 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Type 1 Diabetes
Preservation of Insulin Secretion
Newly Diagnosed Type 1 Diabetes
Canakinumab in Type 1 Diabetes
Interventions: Drug: canakinumab (anti IL-1beta)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Injection Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
Canakinumab (Anti IL-1beta) canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months

Participant Flow:   Overall Study
    Placebo Injection   Canakinumab (Anti IL-1beta)
STARTED   22   49 [1] 
COMPLETED   21   45 
NOT COMPLETED   1   4 
Withdrawal by Subject                1                3 
Protocol Violation                0                1 
[1] 2 participants discontinued prior to any study drug administration



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Injection Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
Canakinumab (Anti IL-1beta) canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
Total Total of all reporting groups

Baseline Measures
   Placebo Injection   Canakinumab (Anti IL-1beta)   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   49   71 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.4  (6.4)   11.6  (4.0)   11.8  (4.8) 
Gender 
[Units: Participants]
     
Female   8   25   33 
Male   14   24   38 


  Outcome Measures

1.  Primary:   C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Carla Greenbaum
Organization: Benaroya Research Institute
e-mail: cjgreen@benaroyaresearch.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00947427     History of Changes
Other Study ID Numbers: TrialNet-cana (IND)
Study First Received: July 24, 2009
Results First Received: May 12, 2016
Last Updated: August 24, 2016
Health Authority: United States: Food and Drug Administration