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Trial record 93 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT00947427
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, 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
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Injection Canakinumab (Anti IL-1beta)
Hide Arm/Group Description Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
Period Title: Overall Study
Started 22 49 [1]
Completed 21 45
Not Completed 1 4
Reason Not Completed
Withdrawal by Subject             1             3
Protocol Violation             0             1
[1]
2 participants discontinued prior to any study drug administration
Arm/Group Title Placebo Injection Canakinumab (Anti IL-1beta) Total
Hide Arm/Group Description Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months Total of all reporting groups
Overall Number of Baseline Participants 22 49 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 49 participants 71 participants
12.4  (6.4) 11.6  (4.0) 11.8  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 49 participants 71 participants
Female
8
  36.4%
25
  51.0%
33
  46.5%
Male
14
  63.6%
24
  49.0%
38
  53.5%
1.Primary Outcome
Title C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Injection Canakinumab (Anti IL-1beta)
Hide Arm/Group Description:
Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
Overall Number of Participants Analyzed 21 45
Geometric Mean (95% Confidence Interval)
Unit of Measure: nmol/L
0.40
(0.30 to 0.49)
0.41
(0.34 to 0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection, Canakinumab (Anti IL-1beta)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Injection Canakinumab (Anti IL-1beta)
Hide Arm/Group Description Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
All-Cause Mortality
Placebo Injection Canakinumab (Anti IL-1beta)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Injection Canakinumab (Anti IL-1beta)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/22 (4.55%)      1/49 (2.04%)    
Endocrine disorders     
Endocrine - Other  1  0/22 (0.00%)  0 1/49 (2.04%)  1
Nervous system disorders     
Seizure  1  1/22 (4.55%)  1 0/49 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Injection Canakinumab (Anti IL-1beta)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/22 (68.18%)      30/49 (61.22%)    
Blood and lymphatic system disorders     
Neutrophils/granulocytes (ANC/AGC)  1  3/22 (13.64%)  7 8/49 (16.33%)  12
Gastrointestinal disorders     
Vomiting  1  3/22 (13.64%)  4 3/49 (6.12%)  3
General disorders     
Pain - Other  1  2/22 (9.09%)  3 4/49 (8.16%)  10
Infections and infestations     
Infection - Other  1  6/22 (27.27%)  10 7/49 (14.29%)  9
Infection with unknown ANC- Middle ear (otitis media)  1  1/22 (4.55%)  2 3/49 (6.12%)  4
Infection with unknown ANC- Pharynx  1  2/22 (9.09%)  2 5/49 (10.20%)  5
Infection with unknown ANC- Sinus  1  1/22 (4.55%)  1 4/49 (8.16%)  5
Infection with unknown ANC- Skin (cellulitis)  1  3/22 (13.64%)  3 3/49 (6.12%)  4
Infection with unknown ANC- Upper airway  1  3/22 (13.64%)  3 1/49 (2.04%)  1
Musculoskeletal and connective tissue disorders     
Fracture  1  0/22 (0.00%)  0 3/49 (6.12%)  3
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Other  1  2/22 (9.09%)  2 6/49 (12.24%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
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)
First Submitted: July 24, 2009
First Posted: July 28, 2009
Results First Submitted: May 12, 2016
Results First Posted: October 18, 2016
Last Update Posted: October 18, 2016