A Safety and Efficacy Study of Canagliflozin in Older Pat... | NCT01106651 | Trialant
NCT01106651
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Nov 4, 2014Estimated
Enrollment
716Actual
Phase
Phase 3
Conditions
Diabetes Mellitus, Type 2
Interventions
Canagliflozin 100 mg
Canagliflozin 300 mg
Antihyperglycemic agent(s)
Placebo
Countries
United States
Australia
Canada
Colombia
France
Greece
Hong Kong
India
New Zealand
Poland
Romania
South Africa
Spain
Sweden
Switzerland
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01106651
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR017014
Secondary IDs
ID
Type
Description
Link
28431754DIA3010
Other Identifier
Janssen Research & Development, LLC
Brief Title
A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Oct 2014
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
Jun 2010
Primary Completion Date
Nov 2011Actual
Completion Date
May 2013Actual
First Submitted Date
Apr 1, 2010
First Submission Date that Met QC Criteria
Apr 16, 2010
First Posted Date
Apr 20, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 1, 2013
Results First Submitted that Met QC Criteria
Apr 1, 2013
Results First Posted Date
May 29, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 30, 2012
Certification/Extension First Submitted that Passed QC Review
Apr 24, 2012
Certification/Extension First Posted Date
Apr 25, 2012Estimated
Last Update Submitted Date
Oct 27, 2014
Last Update Posted Date
Nov 4, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.
Detailed Description
Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), placebo-controlled, parallel-group, 3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy to control their diabetes. Approximately 720 older (55 to 80 years of age) patients with T2DM who are either not on an antihyperglycemic agent or who are receiving treatment with a stable regimen of antihyperglycemic agent(s) and have inadequate glycemic (blood sugar) control will receive once daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 104 weeks (includes 26 weeks of double-blind treatment followed by a 78-week extension period). In addition, all patients will take stable doses of the antihyperglycemic agent(s) that they were taking before entry in the study for the duration of the study. Patients will participate in the study for approximately 108 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with an antihyperglycemic agent (rescue therapy) that is considered clinically appropriate and consistent with local prescribing information. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, measures of bone health, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self-monitored blood glucose (SMGB) measurements. The primary outcome measure in the study is the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. All patients will take single-blind placebo capsules for 2 weeks before randomization. After randomization, patients will take double blind canagliflozin (100 mg or 300 mg) or matching placebo for 104 weeks.
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
Canagliflozin
Placebo
Hemoglobin A1c
Bone
Type 2 diabetes mellitus
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
716Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Canagliflozin 100 mg
Experimental
Each patient will receive 100 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Drug: Canagliflozin 100 mg
Drug: Antihyperglycemic agent(s)
Canagliflozin 300 mg
Experimental
Each patient will receive 300 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Drug: Canagliflozin 300 mg
Drug: Antihyperglycemic agent(s)
Placebo
Placebo Comparator
Each patient will receive matching placebo once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Drug: Antihyperglycemic agent(s)
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Canagliflozin 100 mg
Drug
One 100 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in HbA1c From Baseline to Week 26
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Patients With HbA1c <7% at Week 26
The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Week 26
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
All patients must have a diagnosis of T2DM and may be currently treated with a stable regimen of antihyperglycemic agent(s)
Patients in the study must have a HbA1c between >=7 and <=10.0%
Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)
Exclusion Criteria:
History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
55 Years
Maximum Age
80 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
Janssen Research & Development, LLC Clinical Trial
Januzzi JL Jr, Butler J, Jarolim P, Sattar N, Vijapurkar U, Desai M, Davies MJ. Effects of Canagliflozin on Cardiovascular Biomarkers in Older Adults With Type 2 Diabetes. J Am Coll Cardiol. 2017 Aug 8;70(6):704-712. doi: 10.1016/j.jacc.2017.06.016. Epub 2017 Jun 12.
Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
716 patients were randomly allocated to the 3 treatment arms. 714 patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and safety analysis set. Participant flow is presented for Baseline to Week 104 (Overall Study).
Recruitment Details
This study evaluated the efficacy and safety of canagliflozin in older patients with type 2 diabetes mellitus with inadequate control on their current diabetes treatment regimen. The study began on 07 June 2010 and ended on 23 May 2013. Patients were recruited from 90 study centers located in 17 countries worldwide.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
FG001
Canagliflozin 100 mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Brazil
Estonia
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Canagliflozin 100 mg
Canagliflozin 300 mg
Drug
One 300 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Canagliflozin 300 mg
Antihyperglycemic agent(s)
Drug
Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4] inhibitors, metformin, insulin [all types]) and their combinations (sulfonylurea agent and insulin [all types], metformin and insulin [all types], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4]) are used as per protocol specifications.
Canagliflozin 100 mg
Canagliflozin 300 mg
Placebo
Placebo
Drug
One matching placebo capsule orally once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Placebo
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Percent Change in Body Weight From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Percent Change in Triglycerides From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Day 1 (Baseline) and Week 26
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
Day 1 (Baseline) and Week 26
Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
Day 1 (Baseline) and Week 26
Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
Day 1 (Baseline) and Week 26
Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
Blonde L, Stenlof K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7.
Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.
Bilezikian JP, Watts NB, Usiskin K, Polidori D, Fung A, Sullivan D, Rosenthal N. Evaluation of Bone Mineral Density and Bone Biomarkers in Patients With Type 2 Diabetes Treated With Canagliflozin. J Clin Endocrinol Metab. 2016 Jan;101(1):44-51. doi: 10.1210/jc.2015-1860. Epub 2015 Nov 18.
Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.
Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.
Bode B, Stenlof K, Sullivan D, Fung A, Usiskin K. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract (1995). 2013 Apr;41(2):72-84. doi: 10.3810/hp.2013.04.1020.
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
FG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
FG000237 subjects
FG001241 subjects
FG002236 subjects
COMPLETED
FG000158 subjects
FG001184 subjects
FG002178 subjects
NOT COMPLETED
FG00079 subjects
FG00157 subjects
FG00258 subjects
Type
Comment
Reasons
Adverse Event
FG00017 subjects
FG0019 subjects
FG00223 subjects
Lost to Follow-up
FG0008 subjects
FG0012 subjects
FG0026 subjects
Physician Decision
FG0004 subjects
FG0013 subjects
FG0021 subjects
Protocol Violation
FG0001 subjects
FG0012 subjects
FG0021 subjects
Withdrawal by Subject
FG00014 subjects
FG0017 subjects
FG0024 subjects
Noncompliance with study drug
FG0001 subjects
FG0010 subjects
FG0022 subjects
Other
FG00034 subjects
FG00131 subjects
FG00221 subjects
Death
FG0000 subjects
FG0013 subjects
FG0020 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
BG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
BG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000237
BG001241
BG002236
BG003714
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00063.2± 6.21
BG00164.3± 6.46
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00094
BG001117
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
AUSTRALIA
Title
Measurements
BG0006
BG0016
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
Change in HbA1c From Baseline to Week 26
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
Percent
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Units
Counts
Participants
OG000232
OG001239
OG002229
Title
Denominators
Categories
Title
Measurements
OG000-0.03± 0.063
OG001-0.60± 0.063
OG002-0.73± 0.064
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.001
Least-Squares Mean Difference
-0.57
Standard Error of the Mean
0.069
2-Sided
95
-0.708
-0.436
No
Superiority or Other
OG000
OG002
ANCOVA
<0.001
Secondary
Percentage of Patients With HbA1c <7% at Week 26
The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Number
Percentage of patients
Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Secondary
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
mg/dL
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Secondary
Percent Change in Body Weight From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
Percent change
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Secondary
Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
kg
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Secondary
Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
Percent
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Secondary
Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
Percent
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Secondary
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
mmHg
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Secondary
Percent Change in Triglycerides From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
Percent change
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Secondary
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
Percent change
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Secondary
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
Percent change
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Canagliflozin 300 mg
Secondary
Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
Percent change
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Canagliflozin 300 mg
Secondary
Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
Percent change
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Canagliflozin 300 mg
Secondary
Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.
Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.
Posted
Least Squares Mean
Standard Error
Percent change
Day 1 (Baseline) and Week 26
ID
Title
Description
OG000
Placebo
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG001
Canagliflozin 100 mg
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
OG002
Canagliflozin 300 mg
Time Frame
Adverse event data was collected for the duration of the study (104 weeks).
Description
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm. MEDDRA 14.0 used for Week 26 results/ MEDDRA 16.0 used for Week 104 results.
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
Placebo: Baseline to Week 26
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
12
237
99
237
EG001
Canagliflozin 100 mg: Baseline to Week 26
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
10
241
92
241
EG002
Canagliflozin 300 mg: Baseline to Week 26
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
8
236
98
236
EG003
Placebo: Baseline to Week 104
Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104.
41
237
166
237
EG004
Canagliflozin 100 mg: Baseline to Week 104
Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
40
241
169
241
EG005
Canagliflozin 300 mg: Baseline to Week 104
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
43
236
169
236
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG0031 affected237 at risk
EG0041 affected241 at risk
EG0050 affected236 at risk
Atrial fibrillation
Cardiac disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Bradycardia
Cardiac disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0021 affected236 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0021 affected236 at risk
EG003
Coronary artery disease
Cardiac disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0001 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Myocardial infarction
Cardiac disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0002 affected237 at risk
EG0010 affected241 at risk
EG0021 affected236 at risk
EG003
Myocarditis
Cardiac disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0001 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Haematochezia
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0021 affected236 at risk
EG003
Intestinal infarction
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Umbilical hernia, obstructive
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0001 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Pneumonia
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0022 affected236 at risk
EG003
Urinary tract infection
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0001 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Urosepsis
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0002 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0001 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0001 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Bronchioloalveolar carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0021 affected236 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0021 affected236 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0021 affected236 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Presyncope
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Post-traumatic stress disorder
Psychiatric disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Renal colic
Renal and urinary disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0001 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Renal impairment
Renal and urinary disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0001 affected237 at risk
EG0010 affected241 at risk
EG0021 affected236 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Diplopia
Eye disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0011 affected241 at risk
EG0020 affected236 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Angina unstable
Cardiac disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Intracardiac thrombus
Cardiac disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Abdominal hernia obstructive
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Colitis
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Gastrointestinal angiodysplasia haemorrhagic
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Inguinal hernia, obstructive
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Pouchitis
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Non-cardiac chest pain
General disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Drug hypersensitivity
Immune system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Appendicitis perforated
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Cholecystitis infective
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Gastroenteritis
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Otitis media
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Sepsis
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Subcutaneous abscess
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Blood pressure increased
Investigations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Cartilage atrophy
Musculoskeletal and connective tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Adrenal adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Angiosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Benign salivary gland neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Hypoaesthesia
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Hypoglycaemic coma
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Hypoglycaemic seizure
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Loss of consciousness
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Migraine with aura
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Syncope
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Genital prolapse
Reproductive system and breast disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Hypoventilation
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Sinus polyp
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Deep vein thrombosis
Vascular disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Embolism arterial
Vascular disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Haematoma
Vascular disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG00014 affected237 at risk
EG00110 affected241 at risk
EG00211 affected236 at risk
EG00324 affected237 at risk
EG00414 affected241 at risk
EG00524 affected236 at risk
Influenza
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0005 affected237 at risk
EG00114 affected241 at risk
EG0029 affected236 at risk
EG003
Nasopharyngitis
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG00019 affected237 at risk
EG00123 affected241 at risk
EG00219 affected236 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG00011 affected237 at risk
EG00113 affected241 at risk
EG00210 affected236 at risk
EG003
Urinary tract infection
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0009 affected237 at risk
EG00114 affected241 at risk
EG00217 affected236 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG00034 affected237 at risk
EG00125 affected241 at risk
EG00223 affected236 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG00012 affected237 at risk
EG0014 affected241 at risk
EG0025 affected236 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0008 affected237 at risk
EG0016 affected241 at risk
EG00212 affected236 at risk
EG003
Headache
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG00015 affected237 at risk
EG0018 affected241 at risk
EG00213 affected236 at risk
EG003
Pollakiuria
Renal and urinary disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0006 affected237 at risk
EG0016 affected241 at risk
EG00212 affected236 at risk
EG003
Constipation
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Nausea
Gastrointestinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Oedema peripheral
General disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Bronchitis
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Sinusitis
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Dizziness
Nervous system disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Insomnia
Psychiatric disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 at risk
EG003
Hypertension
Vascular disorders
MEDDRA 14.0 / 16.0
Non-systematic Assessment
EG0000 affected237 at risk
EG0010 affected241 at risk
EG0020 affected236 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
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Point of Contact
Title
Organization
Phone
Extension
Email
Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
Janssen Research & Development, LLC
ClinicalTrialDisclosure@its.jnj.com
ID
Term
D003924
Diabetes Mellitus, Type 2
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068896
Canagliflozin
Ancestor Terms
ID
Term
D013876
Thiophenes
D013457
Sulfur Compounds
D009930
Organic Chemicals
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D005960
Glucosides
D006027
Glycosides
D002241
Carbohydrates
Browse Leaves
Not provided
Browse Branches
Not provided
0
Between 18 and 65 years
BG000151
BG001141
BG002149
BG003441
>=65 years
BG00086
BG001100
BG00287
BG003273
63.4
± 5.99
BG00363.6± 6.24
107
BG003318
Male
BG000143
BG001124
BG002129
BG003396
11
BG00323
CANADA
Title
Measurements
BG00024
BG00132
BG00228
BG00384
COLOMBIA
Title
Measurements
BG00018
BG00115
BG00220
BG00353
FRANCE
Title
Measurements
BG0002
BG0012
BG0023
BG0037
GREECE
Title
Measurements
BG0001
BG0011
BG0021
BG0033
HONG KONG
Title
Measurements
BG0001
BG0011
BG0022
BG0034
INDIA
Title
Measurements
BG0008
BG0013
BG00211
BG00322
NEW ZEALAND
Title
Measurements
BG00016
BG00110
BG00211
BG00337
POLAND
Title
Measurements
BG00011
BG00112
BG00214
BG00337
ROMANIA
Title
Measurements
BG0008
BG00110
BG0027
BG00325
SOUTH AFRICA
Title
Measurements
BG0009
BG00112
BG00210
BG00331
SPAIN
Title
Measurements
BG0002
BG0013
BG0028
BG00313
SWEDEN
Title
Measurements
BG0004
BG0014
BG0022
BG00310
SWITZERLAND
Title
Measurements
BG0002
BG0012
BG0020
BG0034
UKRAINE
Title
Measurements
BG0003
BG0018
BG0023
BG00314
UNITED KINGDOM
Title
Measurements
BG00019
BG00122
BG0028
BG00349
UNITED STATES
Title
Measurements
BG000103
BG00198
BG00297
BG003298
Least-Squares Mean Difference
-0.70
Standard Error of the Mean
0.070
2-Sided
95
-0.841
-0.566
No
Superiority or Other
Units
Counts
Participants
OG000232
OG001239
OG002229
Title
Denominators
Categories
Title
Measurements
OG00028.0
OG00147.7
OG00258.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.001
Odds Ratio (OR)
2.96
95
1.93
4.56
No
Superiority or Other
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
4.48
95
2.89
6.95
No
Superiority or Other
Units
Counts
Participants
OG000231
OG001239
OG002229
Title
Denominators
Categories
Title
Measurements
OG0007.39± 2.875
OG001-18.1± 2.860
OG002-20.3± 2.920
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.001
Least-Squares Mean Difference
-25.5
Standard Error of the Mean
3.147
2-Sided
95
-31.68
-19.32
No
Superiority or Other
OG000
OG002
ANCOVA
<0.001
Least-Squares Mean Difference
-27.7
Standard Error of the Mean
3.179
2-Sided
95
-33.97
-21.49
No
Superiority or Other
Units
Counts
Participants
OG000234
OG001240
OG002229
Title
Denominators
Categories
Title
Measurements
OG000-0.1± 0.3
OG001-2.4± 0.3
OG002-3.1± 0.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.001
Least-Squares Mean Difference
-2.3
Standard Error of the Mean
0.3
2-Sided
95
-2.8
-1.7
No
Superiority or Other
OG000
OG002
ANCOVA
<0.001
Least-Squares Mean Difference
-3.0
Standard Error of the Mean
0.3
2-Sided
95
-3.5
-2.4
No
Superiority or Other
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Units
Counts
Participants
OG00050
OG00156
OG00260
Title
Denominators
Categories
Title
Measurements
OG000-0.28± 0.336
OG001-1.87± 0.332
OG002-2.38± 0.323
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.001
Least-Squares Mean Difference
-1.59
Standard Error of the Mean
0.379
2-Sided
95
-2.339
-0.842
No
Superiority or Other
OG000
OG002
ANCOVA
<0.001
Least-Squares Mean Difference
-2.10
Standard Error of the Mean
0.371
2-Sided
95
-2.833
-1.368
No
Superiority or Other
OG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Units
Counts
Participants
OG00050
OG00156
OG00260
Title
Denominators
Categories
Title
Measurements
OG0000.00± 0.270
OG001-1.03± 0.268
OG002-1.18± 0.261
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Region percent total fat
ANCOVA
<0.001
Least-Squares Mean Difference
-1.03
Standard Error of the Mean
0.305
2-Sided
95
-1.633
-0.428
No
Superiority or Other
OG000
OG002
Region percent total fat
ANCOVA
<0.001
Least-Squares Mean Difference
-1.18
Standard Error of the Mean
0.300
2-Sided
95
-1.772
-0.587
No
Superiority or Other
OG002
Canagliflozin 300 mg
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Units
Counts
Participants
OG00050
OG00156
OG00260
Title
Denominators
Categories
Title
Measurements
OG0000.02± 0.280
OG001-1.04± 0.278
OG002-1.18± 0.270
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.001
Least-Squares Mean Difference
-1.05
Standard Error of the Mean
0.316
2-Sided
95
-1.677
-0.430
No
Superiority or Other
OG000
OG002
ANCOVA
<0.001
Least-Squares Mean Difference
-1.20
Standard Error of the Mean
0.311
2-Sided
95
-1.812
-0.584
No
Superiority or Other
Units
Counts
Participants
OG000234
OG001240
OG002229
Title
Denominators
Categories
Title
Measurements
OG0001.10± 1.039
OG001-3.52± 1.035
OG002-6.79± 1.056
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.001
Least-Squares Mean Difference
-4.63
Standard Error of the Mean
1.134
2-Sided
95
-6.854
-2.401
No
Superiority or Other
OG000
OG002
ANCOVA
<0.001
Least-Squares Mean Difference
-7.89
Standard Error of the Mean
1.147
2-Sided
95
-10.14
-5.641
No
Superiority or Other
Units
Counts
Participants
OG000206
OG001227
OG002222
Title
Denominators
Categories
Title
Measurements
OG0007.7± 3.4
OG0012.8± 3.3
OG0028.4± 3.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.194
Least-Squares Mean Difference
-4.8
Standard Error of the Mean
3.7
2-Sided
95
-12.1
2.5
No
Superiority or Other
OG000
OG002
ANCOVA
0.846
Least-Squares Mean Difference
0.7
Standard Error of the Mean
3.7
2-Sided
95
-6.6
8.1
No
Superiority or Other
Units
Counts
Participants
OG000206
OG001225
OG002222
Title
Denominators
Categories
Title
Measurements
OG0001.5± 1.2
OG0016.8± 1.2
OG0026.2± 1.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.001
Least-Squares Mean Difference
5.3
Standard Error of the Mean
1.4
2-Sided
95
2.6
7.9
No
Superiority or Other
OG000
OG002
ANCOVA
<0.001
Least-Squares Mean Difference
4.7
Standard Error of the Mean
1.4
2-Sided
95
2.0
7.4
No
Superiority or Other
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Units
Counts
Participants
OG000185
OG001206
OG002192
Title
Denominators
Categories
Title
Measurements
OG0000.5± 0.3
OG0010.7± 0.3
OG0020.2± 0.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Least-Squares Mean Difference
0.2
Standard Error of the Mean
0.3
2-Sided
95
-0.4
0.8
No
Superiority or Other
OG000
OG002
ANCOVA
Least-Squares Mean Difference
-0.3
Standard Error of the Mean
0.3
2-Sided
95
-0.9
0.3
No
Superiority or Other
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Units
Counts
Participants
OG000187
OG001208
OG002187
Title
Denominators
Categories
Title
Measurements
OG000-0.5± 0.3
OG001-0.7± 0.3
OG002-0.8± 0.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Least-Squares Mean Difference
-0.3
Standard Error of the Mean
0.3
2-Sided
95
-0.9
0.4
No
Superiority or Other
OG000
OG002
ANCOVA
Least-Squares Mean Difference
-0.4
Standard Error of the Mean
0.3
2-Sided
95
-1.0
0.3
No
Superiority or Other
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
Units
Counts
Participants
OG000183
OG001209
OG002190
Title
Denominators
Categories
Title
Measurements
OG000-1.0± 0.3
OG001-0.7± 0.3
OG002-0.6± 0.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Least-Squares Mean Difference
0.3
Standard Error of the Mean
0.3
2-Sided
95
-0.3
1.0
No
Superiority or Other
OG000
OG002
ANCOVA
Least-Squares Mean Difference
0.4
Standard Error of the Mean
0.3
2-Sided
95
-0.3
1.1
No
Superiority or Other
Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.