To Compare the Effect of a Subcutaneous Canakinumab Admin... | NCT01068860 | Trialant
NCT01068860
Sponsor
Novartis
Status
Completed
Last Update Posted
Sep 5, 2011Estimated
Enrollment
246Actual
Phase
Phase 2
Conditions
Type 2 Diabetes Mellitus
Impaired Glucose Tolerance
Interventions
Canakinumab 150 mg
Placebo to Canakinumab
Countries
United States
Australia
Canada
Finland
Germany
India
Italy
Protocol Section
Identification Module
NCT ID
NCT01068860
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CACZ885I2207
Secondary IDs
Not provided
Brief Title
To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies
Official Title
A Multi-center, Double-blind, Placebo-controlled, Randomized Study to Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes Treated With Differing Baseline Diabetes Therapies
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Aug 2011
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
Feb 2010
Primary Completion Date
Aug 2010Actual
Completion Date
Aug 2010Actual
First Submitted Date
Feb 12, 2010
First Submission Date that Met QC Criteria
Feb 12, 2010
First Posted Date
Feb 15, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 3, 2011
Results First Submitted that Met QC Criteria
Aug 3, 2011
Results First Posted Date
Sep 5, 2011Estimated
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
Aug 3, 2011
Last Update Posted Date
Sep 5, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
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
This was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Impaired Glucose Tolerance
Keywords
Type 2 Diabetes Mellitus
canakinumab
Pre diabetic
glucose intolerant
oral anti diabetic medication
insulin treatment
metabolic syndrome
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
246Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Canakinumab 150 mg + Metformin
Experimental
Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Drug: Canakinumab 150 mg
Placebo + Metformin
Placebo Comparator
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Drug: Placebo to Canakinumab
Canakinumab 150 mg + Metforimin + Sulfonylurea
Experimental
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Drug: Canakinumab 150 mg
Placebo + Metforimin + Sulfonylurea
Placebo Comparator
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Canakinumab 150 mg
Drug
Single subcutaneous injection of Canakinumab 150 mg.
Canakinumab 150 mg + Insulin
Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.
Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal.A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include patients from the IGT population
Baseline, 4 weeks
Secondary Outcomes
Measure
Description
Time Frame
Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks
Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient must fulfill all criteria in one of the following groups:
Impaired Glucose Tolerance (IGT) as diagnosed per protocol and not on an anti-diabetic medicine during the study
Diagnosis of Type 2 diabetes in stable treatment with metformin
Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day) in combination with a sulfonylurea
Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day), sulfonylurea and thiazolidinedione combination therapy
Diagnosis of Type 2 diabetes in stable treatment with at least two insulin injections a day with or without metformin
HbA1c between 6.5% and 8%, inclusive, at Screening; this criterion does not apply to the IGT group
Age from 18-74 years, inclusive, and of either sex
Exclusion Criteria:
Type 1 diabetes or diabetes that is a result of pancreatic injury or other secondary forms of diabetes
History or current findings of active pulmonary disease (e.g. tuberculosis, fungal diseases) as defined in the protocol:
Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
74 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 Pharmaceuticals Corporation
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
National Research Institute
Los Angeles
California
United States
Crest Clinical Trials
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
Qualified patients entered a 4-week run-in period while taking current therapy thru the study. After the run-in, patients had the baseline meal challenge. Then patients were randomized. A 2nd meal challenge was performed after 4 wks. This ended the study except for a follow up phone call after approx.90 days to record serious adverse events (SAEs)
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione
Experimental
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Drug: Canakinumab 150 mg
Placebo + Met + Sulfonyl + Thiazolidinedione
Placebo Comparator
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Drug: Placebo to Canakinumab
Canakinumab 150 mg + Insulin
Experimental
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Drug: Canakinumab 150 mg
Placebo + Insulin
Placebo Comparator
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
Drug: Placebo to Canakinumab
Canakinumab 150 mg in patients with IGT
Experimental
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Drug: Canakinumab 150 mg
Placebo in patients with IGT
Placebo Comparator
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Drug: Placebo to Canakinumab
Canakinumab 150 mg + Metforimin + Sulfonylurea
Canakinumab 150 mg + Metformin
Canakinumab 150 mg in patients with IGT
ACZ885
Glucophage
Chlorpropramide
Diabinese
Acetohexamide
Dymelor
Tolazamise
Tolinase
Tolbutamise
Orinase
Glipizide
Glucotrol
Glimepiride
Amaryl
Glyburide
DiaBeta
Micronase
Glynase PresTab
Troglitazone
Rezulin
Insulin
Iletin
Novolin
Velosulin
Humalog
Humulin
Lente
Ultralente
NPH Iletin
Placebo to Canakinumab
Drug
Single subcutaneous injection of Placebo to Canakinumab.
Placebo + Insulin
Placebo + Met + Sulfonyl + Thiazolidinedione
Placebo + Metforimin + Sulfonylurea
Placebo + Metformin
Placebo in patients with IGT
ACZ885
Glucophage
Chlorpropramide
Diabinese
Acetohexamide
Dymelor
Tolazamise
Tolinase
Tolbutamise
Orinase
Glipizide
Glucotrol
Glimepiride
Amaryl
Glyburide
DiaBeta
Micronase
Glynase PresTab
Troglitazone
Rezulin
Insulin
Iletin
Novolin
Velosulin
Humalog
Humulin
Lente
Ultralente
NPH Iletin
Baseline, 4 weeks
Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.
Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose, insulin and C-peptide at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Baseline, 4 weeks
Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks
Change in Fasting Glucose Level measured from plasma taken at Baseline and after 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
Baseline, 4 weeks
Mean Change in Fructosamine, From Baseline to 4 Weeks
Change in Fructosamine Level taken from plasma, measured at Baseline and after 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
Baseline, 4 weeks
Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks
Change in Fasting Insulin level taken from plasma, measured at Baseline and after 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
Baseline, 4 weeks
Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks
The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects the mean score ± SE is 0.366 ± 0.029.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Baseline, 4 weeks
Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks
GDI 1 is the product of insulin sensitivity index (Si)during the 1st phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR).GDI 2 is the product of (Si)during the 2nd phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR). A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT group.
Baseline, 4 weeks
Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks
Change in glucose level measured after 2 hours of fasting. Blood sample was drawn at 0 minutes and at 240 minutes.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Baseline, 4 weeks
Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks
Blood samples were drawn after a test meal 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). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
Baseline, 4 weeks
Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks
Blood samples were drawn after a test meal 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). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
Baseline, 4 weeks
Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks
Blood samples were drawn after a test meal 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). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
Baseline, 4 weeks
Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks
Change in peak plasma glucose level as measured from Baseline to 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Baseline, 4 weeks
Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks
Change in mean peak plasma Insulin level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Baseline, 4 weeks
Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks
Change in mean peak plasma C-peptide level measured from Baseline to 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Baseline, 4 weeks
Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks
An adverse event is any unwanted event, whether related to study drug or not occuring 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, 4 weeks
Santa Ana
California
United States
Encompass Clinical Research
Spring Valley
California
United States
Commonwealth Biomedical Research LLC
Madisonville
Kentucky
United States
University of Nebraska Medical Center
Omaha
Nebraska
United States
VA Medical Center
Omaha
Nebraska
United States
Lillestol Research LLC
Fargo
North Dakota
United States
Preferred Primary Care Physicians
Pittsburgh
Pennsylvania
United States
Dallas Diabetes and Endocrine Center
Dallas
Texas
United States
Texas Center for Drug Development P.A.
Houston
Texas
United States
Utah Clinical Trials
Salt Lake City
Utah
United States
Barwon Health - Geelong Hospital
Geelong
Victoria
Australia
Austin Health - Heidelberg Repatriation Hospital
Heidelberg Heights
Victoria
Australia
Melbourne Health - Royal Melbourne Hospital
Melbourne
Victoria
Australia
Lifestyle Metabolism Centre (Etobicoke)
Etobicoke
Ontario
Canada
LMC Endocrinology Centres (Markham) Ltd
Markham
Ontario
Canada
LMC Endocrinology Centres (Thornhill) Ltd
Thornhill
Ontario
Canada
Centre de recherche clinique de Laval
Laval
Quebec
Canada
Hôpital Maisonneuve-Rosemont
Montreal
Quebec
Canada
Lihavuustutkimusyksikkö
Helsinki
Finland
Lääkärikeskus Mehiläinen Töölö
Helsinki
Finland
ODL Terveys Oy
Oulu
Finland
Clintrial Berlin Praxis fuer medizinische Studien
Berlin
Germany
Klinische Forschung Berlin-Buch Dr. Andrei Khariouzov
Berlin
Germany
Gemeinschaftspraxis Dr. Ingo Zeissig
Duisburg
Germany
"Sana Krankenhaus Gerresheim
Düsseldorf
Germany
Praxis Dr. Thorsten Rau
Essen
Germany
Praxis Dr. med. Joerg Luedemann
Falkensee
Germany
Dr. Helmut Anderten Gemeinschaftspraxis Dres. Anderten und Krok
Hildesheim
Germany
Praxis Dr. Julia Chevts
Karlsruhe
Germany
Pro Scientia Med
Lübeck
Germany
Praxis Dr. Winfried Keuthage
Münster
Germany
Praxis Dr. Uwe Boeckmann
Neumünster
Germany
Dr. Klaus Funke IkFE Studiencenter Potsdam GMBH I.G.
Potsdam
Germany
Praxis Dr. Gerhard Steinmaier
Viernheim
Germany
Praxis Dr. Reinhold U. Schneider
Wetzlar-Naunheim
Germany
Visakha Diabetes & Endocrine Centre
Visakhapatnam
Andhra Pradesh
India
Jnana Sanjeevini Medical Center
Bangalore
Kar
India
Bangalore Diabetes Hospital,
Banglore
KAR
India
Health & Research Centre
Trivandrum
Ker
India
Diabetes Thyroid Hormone Research Institute Pvt .Ltd.
Indore
Madhya Pradesh
India
Indrayani Speciality Hospital,
Nagpur
Maharashtra
India
Sahyadri Hospital Bibewewadi Centre of Excellence for Diabetics
Pune
Mah
India
Madras Diabetes Research Foundation
Chennai
Tamil Nadu
India
Azienda Ospedaliera-Ospedali Riuniti di BergamoU
Bergamo
BG
Italy
Az. Ospedaliera Universit. S.Martino-Universita degli Studi
Genova
GE
Italy
Azienda Ospedaliera S. Paolo-Polo Universitario
Milan
MI
Italy
Fondazione Centro San Raffaele del Monte Tabor-IRCCSUnità
Milan
Mi
Italy
Az. Ospedaliera Della Prov.di Pavia
Casorate Primo
PV
Italy
Policlinico A.Gemelli - Univ.Cattolica del Sacro Cuore
Roma
Roma
Italy
A.O.Universitaria Senese, Universita degli Studi di Siena
Siena
SI
Italy
S.C.D.U. Endocrinologia e Malattie del Metabolismo
Torino
To
Italy
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
FG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
FG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
FG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
FG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
FG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
FG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
FG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
FG00033 subjects
FG00117 subjects
FG00233 subjects
FG00317 subjects
FG00432 subjects
FG00516 subjects
FG00628 subjects
FG00715 subjects
FG00828 subjects
FG00927 subjects
COMPLETED
FG00033 subjects
FG00116 subjects
FG00233 subjects
FG00316 subjects
FG00432 subjects
FG00514 subjects
FG00628 subjects
FG00715 subjects
FG00828 subjects
FG00923 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0094 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
Administrative problems; misrandomized
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
BG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
BG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
BG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
BG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
BG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
BG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
BG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
BG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00033
BG00117
BG00233
BG00317
BG00432
BG00516
BG00628
BG00715
BG00828
BG00927
BG010246
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00055.9± 10.50
BG00156.5± 9.30
BG00260.0± 8.17
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00019
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
Primary
Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.
Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal.A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include patients from the IGT population
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
pmol/min/m^2/mmol/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00032
OG00116
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.06± 0.943
OG001-0.23± 1.334
OG0020.04± 0.958
OG003
Secondary
Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks
Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
pmol/min/m^2/mmol/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Secondary
Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.
Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose, insulin and C-peptide at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
pmol/min/m^2/mmol/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Secondary
Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks
Change in Fasting Glucose Level measured from plasma taken at Baseline and after 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
mmol/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG002
Secondary
Mean Change in Fructosamine, From Baseline to 4 Weeks
Change in Fructosamine Level taken from plasma, measured at Baseline and after 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
mmol/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG002
Secondary
Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks
Change in Fasting Insulin level taken from plasma, measured at Baseline and after 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
pmol/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG002
Secondary
Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks
The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects the mean score ± SE is 0.366 ± 0.029.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
number
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Secondary
Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks
GDI 1 is the product of insulin sensitivity index (Si)during the 1st phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR).GDI 2 is the product of (Si)during the 2nd phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR). A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT group.
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
number
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Secondary
Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks
Change in glucose level measured after 2 hours of fasting. Blood sample was drawn at 0 minutes and at 240 minutes.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
mmol/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Secondary
Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks
Blood samples were drawn after a test meal 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). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
pmol*hour/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Secondary
Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks
Blood samples were drawn after a test meal 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). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
nmol*hour/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Secondary
Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks
Blood samples were drawn after a test meal 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). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
mmol*hr/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
Secondary
Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks
Change in peak plasma glucose level as measured from Baseline to 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
mmol/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG002
Secondary
Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks
Change in mean peak plasma Insulin level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
pmol/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG002
Secondary
Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks
Change in mean peak plasma C-peptide level measured from Baseline to 4 weeks of treatment.
A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.
Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.
Posted
Least Squares Mean
Standard Error
nmol/L
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG002
Secondary
Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks
An adverse event is any unwanted event, whether related to study drug or not occuring 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.
Safety Population consisted of all participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Posted
Number
participants
Baseline, 4 weeks
ID
Title
Description
OG000
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
OG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Time Frame
Not provided
Description
Safety Set included all randomized participants who received study drug.
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
Canakinumab 150 mg + Metformin
Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
0
33
0
33
EG001
Placebo + Metformin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
0
17
4
17
EG002
Canakinumab 150 mg + Metforimin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
0
32
6
32
EG003
Placebo + Metforimin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
0
17
3
17
EG004
Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
0
32
4
32
EG005
Placebo + Met + Sulfonyl + Thiazolidinedione
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
0
16
3
16
EG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
0
28
6
28
EG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
0
15
3
15
EG008
Canakinumab 150 mg in Patients With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
0
28
0
28
EG009
Placebo in Patients With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
0
26
0
26
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Vertigo
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected17 at risk
EG0020 affected32 at risk
EG0030 affected17 at risk
EG0040 affected32 at risk
EG0050 affected16 at risk
EG0060 affected28 at risk
EG0070 affected15 at risk
EG0080 affected28 at risk
EG0090 affected26 at risk
Vision blurred
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0020 affected32 at risk
EG003
Visual impairment
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0020 affected32 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected17 at risk
EG0021 affected32 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0020 affected32 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0021 affected32 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0021 affected32 at risk
EG003
Hordeolum
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected17 at risk
EG0020 affected32 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0012 affected17 at risk
EG0020 affected32 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0021 affected32 at risk
EG003
Antinuclear antibody positive
Investigations
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0011 affected17 at risk
EG0020 affected32 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0020 affected32 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0021 affected32 at risk
EG003
Tremor
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0021 affected32 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0020 affected32 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0020 affected32 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0021 affected32 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected33 at risk
EG0010 affected17 at risk
EG0020 affected32 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
Dr. Tom Thuren/Global Brand Medical Director
Novartis Pharmaceuticals
862-778-1828
tom.thuren@novartis.com
ID
Term
D003924
Diabetes Mellitus, Type 2
D018149
Glucose Intolerance
D024821
Metabolic Syndrome
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
D006943
Hyperglycemia
D007333
Insulin Resistance
D006946
Hyperinsulinism
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C541220
canakinumab
D008687
Metformin
D002747
Chlorpropamide
D000092
Acetohexamide
D014042
Tolazamide
D014044
Tolbutamide
D005913
Glipizide
C057619
glimepiride
D005905
Glyburide
D000077288
Troglitazone
D007328
Insulin
D061389
Insulin, Regular, Pork
D061268
Insulin Lispro
D061386
Insulin, Regular, Human
Ancestor Terms
ID
Term
D001645
Biguanides
D006146
Guanidines
D000578
Amidines
D009930
Organic Chemicals
D000096926
Benzenesulfonamides
D013449
Sulfonamides
D000577
Amides
D013453
Sulfonylurea Compounds
D014508
Urea
D001555
Benzene Derivatives
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D013450
Sulfones
D013457
Sulfur Compounds
D045162
Thiazolidinediones
D013844
Thiazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D002839
Chromans
D001578
Benzopyrans
D011714
Pyrans
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D011384
Proinsulin
D061385
Insulins
D010187
Pancreatic Hormones
D036361
Peptide Hormones
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D061266
Insulin, Short-Acting
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
59.4
± 8.02
BG00459.1± 10.63
BG00557.2± 9.39
BG00658.6± 10.11
BG00757.0± 13.86
BG00852.8± 10.90
BG00957.6± 10.07
BG01057.4± 10.16
14
BG00310
BG00411
BG0055
BG00613
BG00710
BG00812
BG00916
BG010113
Male
BG00014
BG00114
BG00219
BG0037
BG00421
BG00511
BG00615
BG0075
BG00816
BG00911
BG010133
15
OG00431
OG00514
OG00626
OG00715
OG00828
OG00921
0.45
± 1.378
OG004-0.79± 0.958
OG0051.16± 1.426
OG0061.23± 1.046
OG007-0.49± 1.378
OG008-1.50± 1.975
OG009-1.93± 1.737
OG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00032
OG00116
OG00230
OG00315
OG00431
OG00514
OG00626
OG00715
OG00828
OG00920
Title
Denominators
Categories
Title
Measurements
OG0000.21± 2.000
OG001-2.15± 2.829
OG002-2.98± 2.066
OG0032.02± 2.921
OG0040.15± 2.032
OG0051.19± 3.024
OG006-0.43± 2.219
OG007-0.51± 2.921
OG008-0.71± 1.040
OG009-1.00± 1.518
OG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00033
OG00116
OG00231
OG00315
OG00432
OG00514
OG00626
OG00715
OG00828
OG00921
Title
Denominators
Categories
Title
Measurements
OG0000.44± 0.858
OG001-0.99± 1.232
OG002-0.32± 0.885
OG0031.22± 1.272
OG004-0.63± 0.871
OG0051.24± 1.317
OG0060.53± 0.966
OG007-0.49± 1.272
OG008-1.38± 1.356
OG009-1.35± 1.330
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00033
OG00116
OG00231
OG00316
OG00432
OG00514
OG00626
OG00715
OG00828
OG00921
Title
Denominators
Categories
Title
Measurements
OG000-0.32± 0.272
OG0010.33± 0.391
OG002-0.20± 0.281
OG003-0.23± 0.391
OG004-0.33± 0.276
OG005-0.36± 0.418
OG006-0.26± 0.307
OG007-0.80± 0.404
OG008-0.06± 0.107
OG0090.10± 0.094
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00033
OG00116
OG00231
OG00316
OG00432
OG00514
OG00627
OG00715
OG00828
OG00923
Title
Denominators
Categories
Title
Measurements
OG000-5.30± 3.727
OG001-0.75± 5.353
OG002-3.45± 3.846
OG003-7.50± 5.353
OG004-1.81± 3.785
OG005-3.07± 5.722
OG006-3.00± 4.121
OG007-19.73± 5.528
OG008-6.36± 3.259
OG0091.39± 3813
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00033
OG00115
OG00230
OG00315
OG00431
OG00513
OG00626
OG00715
OG00828
OG00923
Title
Denominators
Categories
Title
Measurements
OG000-3.58± 8.703
OG00110.73± 12.908
OG002-16.07± 9.128
OG003-9.40± 12.908
OG004-0.77± 8.979
OG0052.31± 13.866
OG00621.27± 9.805
OG00725.67± 12.908
OG008-.021± 6.093
OG009-3.43± 4.554
OG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00033
OG00115
OG00230
OG00315
OG00431
OG00513
OG00625
OG00715
OG00828
OG00921
Title
Denominators
Categories
Title
Measurements
OG0000.004± 0.0080
OG001-0.000± 0.0119
OG0020.002± 0.0084
OG0030.009± 0.0119
OG0040.018± 0.0083
OG005-0.001± 0.0128
OG006-0.003± 0.0092
OG0070.005± 0.0119
OG008-0.001± 0.0051
OG0090.001± 0.0034
OG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00032
OG00115
OG00230
OG00315
OG00430
OG00513
OG00625
OG00715
OG00826
OG00921
Title
Denominators
Categories
Index 1
Title
Measurements
OG0000.06± 0.374
OG001-0.29± 0.546
OG0020.06± 0.386
OG0030.37± 0.546
OG0040.24± 0.386
OG0050.33± 0.586
OG0060.25± 0.423
OG007-0.27± 0.546
OG008-0.51± 0.672
OG009-0.64± 0.530
Index 2 (n= 32,15, 29,15, 30,13, 25, 15, 20, 26)
Title
Measurements
OG0000.14± 0.652
OG001-0.81± 0.952
OG002-0.94± 0.685
OG003
OG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00032
OG00116
OG00231
OG00315
OG00431
OG00514
OG00626
OG00715
OG00828
OG00921
Title
Denominators
Categories
Title
Measurements
OG000-0.53± 0.389
OG0010.13± 0.551
OG002-0.60± 0.396
OG0030.18± 0.551
OG004-1.08± 0.396
OG005-0.56± 0.589
OG006-0.56± 0.432
OG007-0.16± 0.569
OG008-0.26± 0.241
OG009-0.25± 0.213
OG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00032
OG00116
OG00231
OG00315
OG00431
OG00514
OG00626
OG00715
OG00828
OG00921
Title
Denominators
Categories
Title
Measurements
OG000-9.37± 40.538
OG0011.21± 60.128
OG002-73.25± 42.517
OG003-38.32± 60.128
OG004-36.96± 41.825
OG0058.46± 64.587
OG006163.87± 45.670
OG007139.24± 60.128
OG00844.27± 60.700
OG009-106.68± 53.615
OG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00032
OG00116
OG00231
OG00315
OG00431
OG00514
OG00626
OG00715
OG00828
OG00921
Title
Denominators
Categories
Title
Measurements
OG000-0.18± 0.225
OG001-0.18± 0.324
OG002-0.21± 0.232
OG0030.12± 0.334
OG004-0.61± 0.229
OG0050.02± 0.346
OG0060.16± 0.249
OG007-0.29± 0.334
OG008-0.43± 0.253
OG009-0.40± 0.288
OG002
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00032
OG00116
OG00231
OG00315
OG00431
OG00514
OG00626
OG00715
OG00828
OG00921
Title
Denominators
Categories
Title
Measurements
OG000-0.59± 1.296
OG0010.46± 1.861
OG002-1.37± 1.337
OG003-1.24± 1.861
OG004-3.58± 1.316
OG005-2.88± 1.990
OG006-1.49± 1.460
OG007-1.76± 1.922
OG008-0.71± 0.554
OG009-0.10± 0.512
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00032
OG00116
OG00231
OG00315
OG00431
OG00514
OG00626
OG00715
OG00828
OG00921
Title
Denominators
Categories
Title
Measurements
OG000-0.41± 0.369
OG0010.21± 0.531
OG002-0.43± 0.381
OG003-0.03± 0.531
OG004-0.82± 0.375
OG005-0.77± 0.567
OG006-0.15± 0.416
OG007-0.60± 0.548
OG008-0.34± 0.181
OG009-0.04± 0.189
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00032
OG00116
OG00231
OG00315
OG00431
OG00514
OG00626
OG00715
OG00828
OG00921
Title
Denominators
Categories
Title
Measurements
OG0008.09± 22.673
OG00144.56± 32.561
OG002-55.07± 23.779
OG00311.33± 33.629
OG0045.13± 23.392
OG005-5.15± 36.123
OG00691.74± 25.065
OG00736.87± 33.629
OG00856.21± 27.952
OG009-26.43± 40.163
Canakinumab 150 mg + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00032
OG00116
OG00231
OG00315
OG00431
OG00514
OG00626
OG00715
OG00828
OG00921
Title
Denominators
Categories
Title
Measurements
OG000-0.04± 0.081
OG001-0.04± 0.116
OG002-0.10± 0.083
OG0030.16± 0.120
OG004-0.21± 0.082
OG0050.05± 0.124
OG0060.07± 0.089
OG007-0.14± 0.120
OG008-0.18± 0.101
OG009-0.18± 0.134
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG003
Placebo + Metformin + Sulfonylurea
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG005
Placebo + Met + Sulfonyl + Thiaz
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
OG006
Canakinumab 150 mg + Insulin
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG007
Placebo + Insulin
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
OG008
Canakinumab 150 mg in Participants With IGT
Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
OG009
Placebo in Participants With IGT
Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
Units
Counts
Participants
OG00033
OG00117
OG00232
OG00317
OG00432
OG00516
OG00628
OG00715
OG00828
OG00926
Title
Denominators
Categories
Number of Participants with Serious Adverse Events