Safety, Tolerability, Pharmacokinetics and Pharmacodynami... | NCT00605475 | Trialant
NCT00605475
Sponsor
Novartis
Status
Completed
Last Update Posted
Feb 13, 2012Estimated
Enrollment
231Actual
Phase
Phase 2
Conditions
Type 2 Diabetes Mellitus
Interventions
Canakinumab
Placebo
Metformin
Countries
United States
Germany
Russia
Protocol Section
Identification Module
NCT ID
NCT00605475
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CACZ885A2213
Secondary IDs
Not provided
Brief Title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes
Official Title
A Multi Center, Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 Administered Intravenously to Patients With Type 2 Diabetes Mellitus
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jan 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2007
Primary Completion Date
Sep 2010Actual
Completion Date
Sep 2010Actual
First Submitted Date
Jan 18, 2008
First Submission Date that Met QC Criteria
Jan 30, 2008
First Posted Date
Jan 31, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 1, 2011
Results First Submitted that Met QC Criteria
Jan 10, 2012
Results First Posted Date
Feb 13, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 10, 2012
Last Update Posted Date
Feb 13, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
NovartisINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose tolerance test (OGTT).
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus
Canakinumab
ACZ885
IL-1B antagonist
metformin
glycemic control
insulin sensitivity
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
231Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Canakinumab
Experimental
Eligible participants were assigned to receive canakinumab in one of four cohorts; 1) Single IV infusion of canakinumab 0.3 mg/kg; 2) Singe IV infusion of canakinumab 10 mg/kg; 3) single IV infusion of canakinumab 0.1 mg/kg or 0.3 mg/kg, or 1.5 mg/kg; 4) Single IV injection of canakinumab 0.03 mg/kg.
All participants were required to take a concomitant stable daily dose of metformin during the study.
Drug: Canakinumab
Drug: Metformin
Placebo
Placebo Comparator
Eligible participants were assigned to receive placebo to canakinumab in one of four cohorts; 1) Single IV infusion of placebo to canakinumab 0.3 mg/kg; 2) Singe IV infusion of placebo to canakinumab 10 mg/kg; 3) single IV infusion of placebo to canakinumab 0.1 mg/kg or 0.3 mg/kg, or 1.5 mg/kg; 4) Single IV injection of placebo to canakinumab 0.03 mg/kg.
All participants were required to take a concomitant stable daily dose of metformin during the study.
Drug: Placebo
Drug: Metformin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Canakinumab
Drug
Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.
Canakinumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Plasma HbA1c (Glycosylated Hemoglobin / Hemoglobin A1c)
Blood was drawn after an overnight fast to measure plasma HbA1c levels. End of Study is defined as the last Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)
Mean Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 - 4 Hours Following Oral Glucose Tolerance Test (OGTT )
Mean Change in Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Glucose levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Secondary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Plasma C-peptide AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test (OGTT)
Blood samples were drawn after an overnight fast and standard OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. C-peptide levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female patients aged 18 to 70 years, with type 2 diabetes mellitus (non-insulin dependent diabetes) for at least 6 months prior to study start
HbA1c between 7.0 and 9.5%
On stable dose metformin monotherapy
Stable body weight
Exclusion Criteria:
Poorly controlled type 2 diabetes (very low or very high blood sugar levels, or other indicators of poor control)
Acute infections prior to dosing
Patients with type 1 diabetes (insulin-dependent diabetes)
Taking diabetes medication (other than metformin)
Other protocol-defined inclusion/exclusion criteria may apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
NOVARTIS
Novartis investigator site
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Arkansas Research Medical Testing
Little Rock
Arkansas
72202
United States
Allied Research International - Cetero Research Miami
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Canakinumab Infusion 0.3 mg/kg
Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
FG001
Cohort 1: Placebo to Canakinumab 0.3 mg/kg
Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
ACZ885
Placebo
Drug
Placebo to Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.
Placebo
Metformin
Drug
Participants continued on their stable daily dose of metformin throughout the study
Canakinumab
Placebo
Glucophage
Glumetza
Baseline, Day 28, Day 84
Mean Change From Baseline in Plasma Insulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Mean Change From Baseline in Plasma Proinsulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Mean Change From Baseline in Plasma Glucagon AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Glucagon levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Mean Change From Baseline in Peak Plasma Insulin/Proinsulin Level, Following Oral Glucose Tolerance Test (OGTT)
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin and proinsulin levels were measured. The insulin/proinsulin level was calculated by dividing the insulin level by the proinsulin level. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Mean Insulin Secretion Rate ( ISR ) Relative to Glucose, 0 - 4 Hours
Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Mean ISR relative to glucose over 0-4 hours was calculated as follows:
Mean ISR relative to glucose = mean ISR / (glucose AUC/time interval). The mean ISR was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Day 28, Day 84
Mean Insulin Secretion Rate ( ISR ), 0 - 4 Hours
Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. The mean ISR over 0 - 4 hours was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Day 28, Day 84
Insulin Sensitivity Index ( ISI ) at Day 28, Day 48
Insulin sensitivity index (ISI) = 10000 / [fasting insulin (μIU/mL) x fasting glucose (mg/dL) x mean 2 hour insulin(μIU/mL) x mean 2 hour glucose (mg/dL)]1/2 where mean 2 hour insulin (or glucose) was defined as the insulin (or glucose)AUC(0-2 hr) divided by the time period (2 hr). In normal subjects the mean score ± SE is 0.366 ± 0.029. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.
Day 28, Day 84
Insulinogenic Index, 0 - 30 Minutes
Insulinogenic index (0-30 min)
[Change in insulin (0-30 min) (μIU/mL)] / [Change in glucose (0-30 min) (mg/dL)]
[insulin (μIU/mL) at 30 min - insulin (μIU/mL) at 0 min] / [glucose (mg/dL) at 30 min - glucose (mg/dL) at 0 min), where insulin (or glucose) at 0 min was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data..](streamdown:incomplete-link)
Day 28, Day 84
Mean Change From Baseline in Peak Plasma Glucose Following Oral Glucose Tolerance Test ( OGTT )
Mean Change in Peak Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Change from baseline assessed at Day 28 and 84. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 28, Day 84
Mean Change From Baseline in Peak Plasma Fructosamine Level
Blood was drawn to measure change in plasma Fructosamine Level, from baseline to Day 14, 28, 56, 84, 126 and End of Study ( defined as the final available post-randomization assessment up to the last regularly scheduled visit at Day 168 [+/- 5]). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
Baseline, Day 14, Day 28, Day 56, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)
Insulin Resistance as Measured by the Homeostatic Model Assessment (HOMA-IR)
Insulin Resistance is measured via the Homeostatic Model Assessment (HOMA-IR) using a computer to model insulin sensitivity. Insulin Sensitivity (HOMA-%S), where 100% is normal, is the reciprocal of insulin resistance (100/S%). HOMA IR = [fasting insulin (μU/mL)] x [fasting plasma glucose (mmol/L)] / 22.5 where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.
Baseline, Day 28, Day 84
β-cell Function as Measured by the Homeostatic Model Assessment (HOMA-β )
β cell function is measured by the Homeostatic Model Assessment(HOMA-β) using a computer to model β cell function and insulin sensitivity . β cell function is related to Insulin Sensitivity (HOMA-%S) and is the reciprocal of insulin resistance (100/S%). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5] where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.
Baseline, Day 28, Day 84
Number of Participants Reporting Death, Serious Adverse Events (SAEs), Adverse Events (AE) Above 5% Frequency
An adverse event is any unwanted event, whether related to study drug or not occurring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.
Baseline to End of Study (56[+/-2] and 168 [+/- 5] days after dosing for Cohort 1 and Cohorts 2-4, respectively)
Miami
Florida
33169
United States
Elite Research Institute Miami
Miami
Florida
33169
United States
International Research Center Towson
MD
Maryland
21286
United States
Covance Clinical Research Unit Inc
Portland
Oregon
97239
United States
Charles River Clinical Services
Northwest Tacoma
Washington
98418
United States
Novartis Investigator Site
Berlin
Germany
Novartis Investigator Site
Kiel
Germany
Novartis Investigator Site
Mönchengladbach
Germany
Novartis Investigator Site
Munich
Germany
Novartis Investigative Site
Neuss
Germany
Novartis Investigative Site
Moscow
Russia
Novartis Investigative Site
Saint Petersberg
Russia
FG002
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
FG003
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
FG004
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
FG005
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Single dose IV infusion of Canakinumab 0.3 mg/kg
FG006
Cohort 3 : Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
FG007
Cohort 3: Placebo Infusion
Single dose IV infusion of Placebo
FG008
Cohort 4 : Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
FG009
Cohort 4: Placebo to Canakinumab 0.03 mg/kg
Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
FG00010 subjects
FG0015 subjects
FG00245 subjects
FG00345 subjects
FG00425 subjects
FG00524 subjects
FG00623 subjects
FG00724 subjects
FG00820 subjects
FG00910 subjects
COMPLETED
FG00010 subjects
FG0015 subjects
FG00245 subjects
FG00345 subjects
FG00424 subjects
FG00522 subjects
FG00622 subjects
FG00724 subjects
FG00818 subjects
FG0098 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
FG0082 subjects
FG0092 subjects
Type
Comment
Reasons
Abnormal Laboratory Values
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Administrative problems
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: Canakinumab Infusion 0.3 mg/kg
Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
BG001
Cohort 1: Placebo to Canakinumab 0.3 mg/kg
Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
BG002
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
BG003
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
BG004
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
BG005
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Single dose IV infusion of Canakinumab 0.3 mg/kg
BG006
Cohort 3 : Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
BG007
Cohort 3: Placebo Infusion
Single dose IV infusion of Placebo
BG008
Cohort 4 : Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
BG009
Cohort 4: Placebo to Canakinumab 0.03 mg/kg
Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG0015
BG00245
BG00345
BG00425
BG00524
BG00623
BG00724
BG00820
BG00910
BG010231
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00053± 7.60
BG00152± 6.96
BG00257.1± 9.38
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Mean Change From Baseline in Plasma C-peptide AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test (OGTT)
Blood samples were drawn after an overnight fast and standard OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. C-peptide levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Least Squares Mean
Standard Error
pmol*h/L
Baseline, Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4): Placebo Infusion
Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Cohort 4: Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG003
Title
Denominators
Categories
Day 28 (n= 41, 41, 21, 23, 23, 31, 20)
Title
Measurements
OG000-335± 178.1
OG001-614± 178.1
OG002-492± 392.4
OG003
Primary
Mean Change From Baseline in Plasma HbA1c (Glycosylated Hemoglobin / Hemoglobin A1c)
Blood was drawn after an overnight fast to measure plasma HbA1c levels. End of Study is defined as the last Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Least Squares Mean
Standard Error
percent
Baseline, Day 28, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2:Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Secondary
Mean Change From Baseline in Plasma Insulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Least Squares Mean
Standard Error
µIU*h/mL
Baseline, Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Secondary
Mean Change From Baseline in Plasma Proinsulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Least Squares Mean
Standard Error
pmol*h/L
Baseline, Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Secondary
Mean Change From Baseline in Plasma Glucagon AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Glucagon levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Least Squares Mean
Standard Error
pmol*h/L
Baseline, Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Primary
Mean Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 - 4 Hours Following Oral Glucose Tolerance Test (OGTT )
Mean Change in Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Glucose levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Least Squares Mean
Standard Error
mmol*h/L
Baseline, Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Secondary
Mean Change From Baseline in Peak Plasma Insulin/Proinsulin Level, Following Oral Glucose Tolerance Test (OGTT)
Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin and proinsulin levels were measured. The insulin/proinsulin level was calculated by dividing the insulin level by the proinsulin level. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Least Squares Mean
Standard Error
pmol/pmol
Baseline, Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Secondary
Mean Insulin Secretion Rate ( ISR ) Relative to Glucose, 0 - 4 Hours
Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Mean ISR relative to glucose over 0-4 hours was calculated as follows:
Mean ISR relative to glucose = mean ISR / (glucose AUC/time interval). The mean ISR was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Least Squares Mean
Standard Error
pmol/min/m^2/mmol/L
Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
Secondary
Mean Insulin Secretion Rate ( ISR ), 0 - 4 Hours
Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. The mean ISR over 0 - 4 hours was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Least Squares Mean
Standard Error
pmol/min/m^2
Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Secondary
Insulin Sensitivity Index ( ISI ) at Day 28, Day 48
Insulin sensitivity index (ISI) = 10000 / [fasting insulin (μIU/mL) x fasting glucose (mg/dL) x mean 2 hour insulin(μIU/mL) x mean 2 hour glucose (mg/dL)]1/2 where mean 2 hour insulin (or glucose) was defined as the insulin (or glucose)AUC(0-2 hr) divided by the time period (2 hr). In normal subjects the mean score ± SE is 0.366 ± 0.029. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Geometric Mean
Standard Error
units on a scale
Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Secondary
Insulinogenic Index, 0 - 30 Minutes
Insulinogenic index (0-30 min)
[Change in insulin (0-30 min) (μIU/mL)] / [Change in glucose (0-30 min) (mg/dL)]
[insulin (μIU/mL) at 30 min - insulin (μIU/mL) at 0 min] / [glucose (mg/dL) at 30 min - glucose (mg/dL) at 0 min), where insulin (or glucose) at 0 min was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data..](streamdown:incomplete-link)
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Geometric Mean
Standard Error
units on a scale
Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Secondary
Mean Change From Baseline in Peak Plasma Glucose Following Oral Glucose Tolerance Test ( OGTT )
Mean Change in Peak Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Change from baseline assessed at Day 28 and 84. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Least Squares Mean
Standard Error
mmol/L
Baseline, Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Cohort 3:Canakinumab Infusion 0.3 mg/kg
Secondary
Mean Change From Baseline in Peak Plasma Fructosamine Level
Blood was drawn to measure change in plasma Fructosamine Level, from baseline to Day 14, 28, 56, 84, 126 and End of Study ( defined as the final available post-randomization assessment up to the last regularly scheduled visit at Day 168 [+/- 5]). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Least Squares Mean
Standard Error
µmol/L
Baseline, Day 14, Day 28, Day 56, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
Units
Counts
Participants
Secondary
Insulin Resistance as Measured by the Homeostatic Model Assessment (HOMA-IR)
Insulin Resistance is measured via the Homeostatic Model Assessment (HOMA-IR) using a computer to model insulin sensitivity. Insulin Sensitivity (HOMA-%S), where 100% is normal, is the reciprocal of insulin resistance (100/S%). HOMA IR = [fasting insulin (μU/mL)] x [fasting plasma glucose (mmol/L)] / 22.5 where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Geometric Mean
Standard Error
units on a scale
Baseline, Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
Secondary
β-cell Function as Measured by the Homeostatic Model Assessment (HOMA-β )
β cell function is measured by the Homeostatic Model Assessment(HOMA-β) using a computer to model β cell function and insulin sensitivity . β cell function is related to Insulin Sensitivity (HOMA-%S) and is the reciprocal of insulin resistance (100/S%). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5] where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.
All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.
Posted
Geometric Mean
Standard Error
percent β-cell Function
Baseline, Day 28, Day 84
ID
Title
Description
OG000
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG001
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG002
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Secondary
Number of Participants Reporting Death, Serious Adverse Events (SAEs), Adverse Events (AE) Above 5% Frequency
An adverse event is any unwanted event, whether related to study drug or not occurring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.
All randomized participants who received study medication were included in the Safety Analysis
Posted
Number
Participants
Baseline to End of Study (56[+/-2] and 168 [+/- 5] days after dosing for Cohort 1 and Cohorts 2-4, respectively)
ID
Title
Description
OG000
Cohort 1: Canakinumab Infusion 0.3 mg/kg
Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
OG001
Cohort 1: Placebo to Canakinumab 0.3 mg/kg
Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
OG002
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
OG003
Cohort 2: Placebo to Canakinumab 10 mg/kg
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1: Canakinumab Infusion 0.3 mg/kg
Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
0
10
1
10
EG001
Cohort 1: Placebo to Canakinumab 0.3 mg/kg
Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
0
5
2
5
EG002
Cohort 2: Canakinumab Infusion 10 mg/kg
Single dose IV infusion of Canakinumab 10 mg/kg
1
45
9
45
EG003
Cohort 2: Placebo to Canakinumab 10 mg/kg
Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
2
45
6
45
EG004
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
0
25
4
25
EG005
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Single dose IV infusion of Canakinumab 0.3 mg/kg
0
24
4
24
EG006
Cohort 3 : Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
0
23
2
23
EG007
Cohort 3: Placebo Infusion
Single dose IV infusion of Placebo
0
24
6
24
EG008
Cohort 4 : Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
0
20
10
20
EG009
Cohort 4: Placebo to Canakinumab 0.03 mg/kg
Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
0
10
2
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG0031 affected45 at risk
EG0040 affected25 at risk
EG0050 affected24 at risk
EG0060 affected23 at risk
EG0070 affected24 at risk
EG0080 affected20 at risk
EG0090 affected10 at risk
Myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG003
Intestinal polyp
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0021 affected45 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ventricular extrasystoles
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG0030 affected45 at risk
EG0040 affected25 at risk
EG0050 affected24 at risk
EG0060 affected23 at risk
EG0070 affected24 at risk
EG0081 affected20 at risk
EG0091 affected10 at risk
Cataract
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected5 at risk
EG0020 affected45 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0021 affected45 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG003
Cystitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0022 affected45 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0027 affected45 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected5 at risk
EG0023 affected45 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0021 affected45 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected5 at risk
EG0020 affected45 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary, however, Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data ( i.e., data from all sites ) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862 778 8300
ID
Term
D003924
Diabetes Mellitus, Type 2
D007333
Insulin Resistance
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
D006946
Hyperinsulinism
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C541220
canakinumab
D008687
Metformin
Ancestor Terms
ID
Term
D001645
Biguanides
D006146
Guanidines
D000578
Amidines
D009930
Organic Chemicals
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
57.5
± 7.95
BG00453.9± 7.58
BG00555± 8.45
BG00655.1± 9.28
BG00754.7± 6.41
BG00853.9± 9.07
BG00956± 8.67
BG01054.6± 8.08
21
BG00314
BG00413
BG00517
BG00614
BG00716
BG00810
BG0092
BG010116
Male
BG0004
BG0012
BG00224
BG00331
BG00412
BG0057
BG0069
BG0078
BG00810
BG0098
BG010115
24
OG00423
OG00534
OG00620
-25
± 367.6
OG004779± 367.6
OG005129± 319.4
OG006-553± 394.6
Day 84 (n= 41, 43, 22, 24, 23, 32, 20)
Title
Measurements
OG000-601± 275.1
OG001-205± 268.6
OG002143± 386.5
OG003143± 361.1
OG004654± 368.9
OG005240± 316.0
OG006-939± 396.1
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4): Placebo Infusion
Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Cohort 4: Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG00324
OG00423
OG00534
OG00620
Title
Denominators
Categories
Day 28 (n= 45, 45, 25, 23, 23, 34, 20)
Title
Measurements
OG000-0.38± 0.057
OG001-0.26± 0.057
OG002-0.25± 0.065
OG003-0.30± 0.069
OG004-0.47± 0.068
OG005-0.24± 0.056
OG006-0.13± 0.073
Day 84 (n= 44, 44, 25, 23, 23, 33, 20)
Title
Measurements
OG000-0.46± 0.102
OG001-0.15± 0.105
OG002-0.04± 0.118
OG003
Day 126 (n= 45, 45, 21, 22, 23, 33, 20)
Title
Measurements
OG000-0.29± 0.101
OG001-0.02± 0.101
OG002-0.08± 0.126
OG003
End of Study (n= 43, 45, 24, 20, 21, 33, 20)
Title
Measurements
OG000-0.26± 0.121
OG001-0.01± 0.118
OG0020.27± 0.162
OG003
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4): Placebo Infusion
Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Cohort 4: Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG00324
OG00423
OG00534
OG00620
Title
Denominators
Categories
Day 28 (n= 43, 45, 18, 21,16, 29, 20)
Title
Measurements
OG000-1.58± 6.156
OG001-14.25± 6.017
OG002-12.61± 8.173
OG0036.06± 7.477
OG0042.06± 8.494
OG005-8.26± 6.421
OG006-1.35± 7.637
Day 84 (n= 43, 45, 22, 23, 19, 31, 20)
Title
Measurements
OG000-19.68± 11.054
OG001-6.97± 10.805
OG002-8.38± 9.095
OG003
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4): Placebo Infusion
Pooled placebo from cohort 3 and 4. ingle dose IV infusion of Placebo
OG006
Cohort 4: Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG00324
OG00423
OG00534
OG00620
Title
Denominators
Categories
Day 28 (n= 36, 37, 22, 24, 21, 30, 20)
Title
Measurements
OG000-9.9± 8.37
OG00111.0± 8.25
OG002-13.7± 18.78
OG003-15.0± 17.64
OG00426.1± 18.81
OG005-16.2± 16.38
OG006-22.3± 19.25
Day 84 (n= 36, 37, 23, 24, 21, 30, 20)
Title
Measurements
OG000-6.2± 10.95
OG0017.8± 10.79
OG002-25.8± 20.96
OG003
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4) Placebo Infusion
Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Cohort 4: Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG00324
OG00423
OG00534
OG00620
Title
Denominators
Categories
Day 28 (n= 41, 44, 22, 23, 23, 34, 20)
Title
Measurements
OG000-3.6± 2.30
OG001-4.0± 2.22
OG002-3.1± 3.43
OG003-3.7± 3.37
OG004-0.6± 3.36
OG005-2.7± 2.78
OG006-5.5± 3.60
Day 84 (n= 42, 45, 23, 23, 23, 33, 20)
Title
Measurements
OG000-3.7± 2.96
OG001-2.0± 2.86
OG002-1.0± 4.46
OG003
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3and 4): Placebo Infusion
Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Cohort 4: Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00043
OG00145
OG00224
OG00324
OG00422
OG00533
OG00620
Title
Denominators
Categories
Day 28
Title
Measurements
OG000-4.7± 0.98
OG001-0.9± 0.96
OG0021.6± 1.66
OG003-0.9± 1.65
OG004-2.8± 1.73
OG005-2.3± 1.41
OG006-0.5± 1.81
Day 84
Title
Measurements
OG000-2.5± 1.26
OG0011.7± 1.24
OG0022.6± 1.72
OG003
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4): Placebo Infusion
Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Cohort 4:Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG00324
OG00423
OG00534
OG00620
Title
Denominators
Categories
Day 28 (n= 43, 45, 24, 24, 23, 34,20)
Title
Measurements
OG0000.173± 0.3902
OG001-1.035± 0.3814
OG0020.160± 0.7996
OG0031.039± 0.7996
OG0040.293± 0.8169
OG005-0.031± 0.6755
OG0060.518± 0.8832
Day 84 (n= 44, 44, 25, 24, 23, 34, 20)
Title
Measurements
OG000-0.852± 0.4890
OG001-0.688± 0.4890
OG002-0.689± 0.7973
OG003
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4) Placebo Infusion
Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG00324
OG00423
OG00534
OG00620
Title
Denominators
Categories
Day 28 (n= 41, 43, 23, 23, 22, 33, 20)
Title
Measurements
OG00020.4± 0.53
OG00118.0± 0.52
OG00214.5± 1.03
OG00317.1± 1.03
OG00419.1± 1.05
OG00518.5± 0.86
OG00616.1± 1.10
Day 84 (n= 42, 43, 24, 24, 22, 33, 20)
Title
Measurements
OG00018.5± 1.00
OG00119.0± 0.99
OG00216.8± 1.13
OG003
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4) Placebo Infusion
Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG00324
OG00423
OG00534
OG00620
Title
Denominators
Categories
Day 28 (n= 42, 43, 23, 23, 23, 33, 20)
Title
Measurements
OG000255± 6.4
OG001246± 6.3
OG002207± 13.1
OG003231± 13.0
OG004262± 13.0
OG005234± 10.9
OG006212± 13.9
Day 84 (n= 43, 43, 25, 24, 23, 34, 20)
Title
Measurements
OG000248± 9.3
OG001259± 9.3
OG002234± 12.6
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4): Placebo Infusion
Pooled placebo of cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Cohort 4: Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG00324
OG00423
OG00534
OG00620
Title
Denominators
Categories
Day 28 (n= 40, 40, 12, 17, 14, 22, 20)
Title
Measurements
OG0002.91± 0.049
OG0012.63± 0.049
OG0023.13± 0.093
OG0032.96± 0.077
OG0043.57± 0.083
OG0053.77± 0.068
OG0063.39± 0.071
Day 84 (n= 39, 43, 13, 20, 14, 27, 20)
Title
Measurements
OG0002.96± 0.043
OG0012.80± 0.041
OG0023.34± 0.109
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4): Placebo Infusion
Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Cohort 4: Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG00324
OG00423
OG00534
OG00620
Title
Denominators
Categories
Day 28 (n=44, 44, 17, 23 17, 32, 18)
Title
Measurements
OG0000.174± 0.0754
OG0010.140± 0.0754
OG0020.090± 0.1995
OG0030.105± 0.1735
OG0040.139± 0.1991
OG0050.102± 0.1464
OG0060.137± 0.1942
Day 84 (n=43, 44, 17, 24, 20, 31, 17)
Title
Measurements
OG0000.157± 0.0987
OG0010.134± 0.0976
OG0020.092± 0.1928
OG003
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3:Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4) Placebo Infusion
Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Cohort 4:Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00044
OG00145
OG00224
OG00324
OG00423
OG00533
OG00620
Title
Denominators
Categories
Day 28
Title
Measurements
OG000-1.3± 0.30
OG0010.0± 0.30
OG0020.2± 0.55
OG003-0.2± 0.55
OG004-0.8± 0.57
OG005-1.0± 0.47
OG0060.1± 0.61
Day 84
Title
Measurements
OG000-0.9± 0.38
OG0010.6± 0.37
OG0020.2± 0.58
OG003
OG00045
OG00145
Title
Denominators
Categories
Day 14 (n= 44, 45)
Title
Measurements
OG0004.8± 3.0
OG001-0.7± 2.97
Day 28 (n= 45, 45)
Title
Measurements
OG000-9.2± 3.72
OG001-13.9± 3.72
Day 56 (n= 43, 44)
Title
Measurements
OG0001.4± 4.88
OG001-0.9± 4.82
Day 84 (n= 44, 45)
Title
Measurements
OG000-16.6± 4.71
OG001-12.1± 4.65
Day 126 (n= 45, 45)
Title
Measurements
OG0001.6± 4.84
OG001-1.1± 4.84
End of Study (n = 45, 45)
Title
Measurements
OG000-2.2± 7.25
OG0014.9± 7.25
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4): Placebo Infusion
Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Cohort 4: Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG00324
OG00423
OG00534
OG00620
Title
Denominators
Categories
Day 28 (n= 44, 45, 24, 24, 22, 33, 20)
Title
Measurements
OG0003.30± 0.059
OG0013.74± 0.058
OG0024.03± 0.092
OG0033.34± 0.091
OG0043.31± 0.095
OG0053.25± 0.078
OG0063.31± 0.101
Day 84 (n= 44, 45, 24, 24, 23, 33, 20)
Title
Measurements
OG0003.37± 0.054
OG0013.62± 0.053
OG0023.87± 0.103
OG003
Single dose IV infusion Canakinumab 0.1 mg/kg
OG003
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG004
Cohort 3: Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG005
Pooled (Cohort 3 and 4) : Placebo Infusion
Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
OG006
Cohort 4: Anakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
Units
Counts
Participants
OG00045
OG00145
OG00225
OG00324
OG00423
OG00534
OG00620
Title
Denominators
Categories
Day 28 (n= 44, 45, 24, 24, 22, 33, 20)
Title
Measurements
OG00040.2± 0.05
OG00135.9± 0.05
OG00238.1± 0.10
OG00338.2± 0.10
OG00442.0± 0.11
OG00537.9± 0.09
OG00638.3± 0.11
Day 84 (n= 44, 45, 24, 24, 23, 33, 20)
Title
Measurements
OG00035.6± 0.06
OG00134.3± 0.06
OG00234.6± 0.10
OG003
Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
OG004
Cohort 3: Canakinumab Infusion 0.1 mg/kg
Single dose IV infusion Canakinumab 0.1 mg/kg
OG005
Cohort 3: Canakinumab Infusion 0.3 mg/kg
Single dose IV infusion of Canakinumab 0.3 mg/kg
OG006
Cohort 3 : Canakinumab Infusion 1.5 mg/kg
Single dose IV infusion of canakinumab 1.5 mg/kg
OG007
Cohort 3: Placebo Infusion
Single dose IV infusion of Placebo
OG008
Cohort 4 : Canakinumab Injection 0.03 mg/kg
Single dose IV injection of Canakinumab 0.03 mg/kg
OG009
Cohort 4: Placebo to Canakinumab 0.03 mg/kg
Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg