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The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01106625
Recruitment Status : Completed
First Posted : April 20, 2010
Results First Posted : May 29, 2013
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Canagliflozin
Drug: Placebo
Drug: Metformin
Drug: Sulphonylruea
Enrollment 469
Recruitment Details This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin and sulphonylurea therapy. The study was conducted between 07 April 2010 and 17 April 2012 and recruited patients from 85 study centers in 11 countries worldwide.
Pre-assignment Details A total of 469 patients were randomly allocated to the 3 treatment arms in the study. All 469 patients received at least 1 dose of study drug and were included in the modified intent-to-treat analysis set (used for the week 26 efficacy analyses). All 469 patients were included in the week 26 and week 52 safety analysis sets.
Arm/Group Title Placebo Canagliflozin 100 mg Canagliflozin 300 mg
Hide Arm/Group Description Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Period Title: Core Period: Baseline to Week 26
Started 156 157 156
Completed 123 129 129
Not Completed 33 28 27
Reason Not Completed
Adverse Event             6             8             8
Lost to Follow-up             5             0             4
Physician Decision             1             0             0
Protocol Violation             2             1             3
Withdrawal by Subject             6             9             7
Unable to take rescue therapy             4             1             0
Creatinine, or eGFR withdrawal criteria             0             1             1
Noncompliance with study drug             1             1             0
Other             8             7             4
Period Title: Extension Period: Week 26 to Week 52
Started 119 [1] 127 [2] 128 [3]
Completed 90 109 111
Not Completed 29 18 17
Reason Not Completed
Adverse Event             2             2             3
Lost to Follow-up             1             3             2
Physician Decision             2             0             1
Protocol Violation             0             1             0
Withdrawal by Subject             4             1             1
Unable to take rescue therapy             14             5             4
Creatinine or eGFR withdrawal criteria             1             1             2
Other             5             5             4
[1]
4 pts discontinued last day of core: physician decision (1), noncompliance (1), not specified (2).
[2]
2 pts discontinued last day of core: adverse event (1), not specified (1).
[3]
1 pt discontinued last day of core: withdrawal by subject (1).
Arm/Group Title Placebo Canagliflozin 100 mg Canagliflozin 300 mg Total
Hide Arm/Group Description Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Total of all reporting groups
Overall Number of Baseline Participants 156 157 156 469
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 157 participants 156 participants 469 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
130
  83.3%
121
  77.1%
134
  85.9%
385
  82.1%
>=65 years
26
  16.7%
36
  22.9%
22
  14.1%
84
  17.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 156 participants 157 participants 156 participants 469 participants
56.7  (8.36) 57.3  (10.47) 56  (8.95) 56.7  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 157 participants 156 participants 469 participants
Female
80
  51.3%
81
  51.6%
69
  44.2%
230
  49.0%
Male
76
  48.7%
76
  48.4%
87
  55.8%
239
  51.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 156 participants 157 participants 156 participants 469 participants
AUSTRALIA 3 6 4 13
BELGIUM 3 1 6 10
FRANCE 4 7 9 20
GUATEMALA 15 12 16 43
HUNGARY 11 14 11 36
ISRAEL 1 6 8 15
MEXICO 11 11 11 33
RUSSIAN FEDERATION 14 13 8 35
SPAIN 5 7 8 20
UNITED KINGDOM 8 6 5 19
UNITED STATES 81 74 70 225
1.Primary Outcome
Title Change in HbA1c From Baseline to Week 26
Hide Description 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.
Time Frame Day 1 (Baseline) and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Canagliflozin 100 mg Canagliflozin 300 mg
Hide Arm/Group Description:
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Overall Number of Participants Analyzed 150 155 152
Least Squares Mean (Standard Error)
Unit of Measure: Percent
-0.13  (0.075) -0.85  (0.075) -1.06  (0.076)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-0.904 to -0.524
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.097
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.114 to -0.732
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.097
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Patients With HbA1c <7% at Week 26
Hide Description 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.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Canagliflozin 100 mg Canagliflozin 300 mg
Hide Arm/Group Description:
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Overall Number of Participants Analyzed 150 155 152
Measure Type: Number
Unit of Measure: Percentage of patients
18 43.2 56.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.42
Confidence Interval (2-Sided) 95%
2.48 to 7.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.80
Confidence Interval (2-Sided) 95%
4.86 to 15.95
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Hide Description 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.
Time Frame Day 1 (Baseline) and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Canagliflozin 100 mg Canagliflozin 300 mg
Hide Arm/Group Description:
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Overall Number of Participants Analyzed 150 155 152
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
4.11  (3.629) -18.2  (3.629) -30.5  (3.650)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -22.3
Confidence Interval (2-Sided) 95%
-31.53 to -13.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.627
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -34.6
Confidence Interval (2-Sided) 95%
-43.86 to -25.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.692
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change in Body Weight From Baseline to Week 26
Hide Description 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 percent change.
Time Frame Day 1 (Baseline) and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Canagliflozin 100 mg Canagliflozin 300 mg
Hide Arm/Group Description:
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Overall Number of Participants Analyzed 150 156 154
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
-0.7  (0.3) -2.1  (0.3) -2.6  (0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.1 to -0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-2.7 to -1.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Hide Description 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.
Time Frame Day 1 (Baseline) and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Canagliflozin 100 mg Canagliflozin 300 mg
Hide Arm/Group Description:
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Overall Number of Participants Analyzed 150 156 154
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-2.65  (0.982) -4.89  (0.976) -4.27  (0.980)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -2.24
Confidence Interval (2-Sided) 95%
-4.719 to 0.241
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.262
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.201
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -1.62
Confidence Interval (2-Sided) 95%
-4.111 to 0.866
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.266
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change in Triglycerides From Baseline to Week 26
Hide Description 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 percent change.
Time Frame Day 1 (Baseline) and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Canagliflozin 100 mg Canagliflozin 300 mg
Hide Arm/Group Description:
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Overall Number of Participants Analyzed 134 145 142
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
11.6  (4.2) 5.4  (4.2) 8.5  (4.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.256
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -6.2
Confidence Interval (2-Sided) 95%
-16.9 to 4.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-13.8 to 7.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.5
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Hide Description The table below shows the least-squares (LS) mean percent change in HDL-C 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 percent change.
Time Frame Day 1 (Baseline) and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Canagliflozin 100 mg Canagliflozin 300 mg
Hide Arm/Group Description:
Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Overall Number of Participants Analyzed 135 145 141
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
3.2  (1.3) 5.7  (1.3) 6.5  (1.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.153
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-0.9 to 5.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 300 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
-0.1 to 6.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.8
Estimation Comments [Not Specified]
Time Frame Adverse events were reported for the duration of the study; each patient participated in the study for approximately 52 weeks.
Adverse Event Reporting 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.
 
Arm/Group Title Placebo: Baseline to Week 26 Canagliflozin 100 mg: Baseline to Week 26 Canagliflozin 300 mg: Baseline to Week 26 Placebo: Baseline to Week 52 Canagliflozin 100 mg: Baseline to Week 52 Canagliflozin 300 mg: Baseline to Week 52
Hide Arm/Group Description Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26. Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26. Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26. Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52. Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52. Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
All-Cause Mortality
Placebo: Baseline to Week 26 Canagliflozin 100 mg: Baseline to Week 26 Canagliflozin 300 mg: Baseline to Week 26 Placebo: Baseline to Week 52 Canagliflozin 100 mg: Baseline to Week 52 Canagliflozin 300 mg: Baseline to Week 52
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo: Baseline to Week 26 Canagliflozin 100 mg: Baseline to Week 26 Canagliflozin 300 mg: Baseline to Week 26 Placebo: Baseline to Week 52 Canagliflozin 100 mg: Baseline to Week 52 Canagliflozin 300 mg: Baseline to Week 52
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/156 (5.77%)   5/157 (3.18%)   6/156 (3.85%)   13/156 (8.33%)   7/157 (4.46%)   8/156 (5.13%) 
Cardiac disorders             
Angina pectoris * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Atrial fibrillation * 1 [1]  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%)  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Coronary artery stenosis * 1 [1]  1/156 (0.64%)  1/157 (0.64%)  0/156 (0.00%)  1/156 (0.64%)  1/157 (0.64%)  0/156 (0.00%) 
Myocardial infarction * 1 [1]  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Gastrointestinal disorders             
Abdominal pain * 1 [1]  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Mechanical ileus * 1 [1]  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
General disorders             
Chest pain * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Ulcer haemorrhage * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%)  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Hepatobiliary disorders             
Biliary dyskinesia * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%)  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Cholecystitis * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%)  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Cholecystitis chronic * 1 [1]  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Infections and infestations             
Diverticulitis * 1 [1]  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Gangrene * 1 [1]  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Lobar pneumonia * 1 [1]  1/156 (0.64%)  0/157 (0.00%)  1/156 (0.64%)  1/156 (0.64%)  0/157 (0.00%)  1/156 (0.64%) 
Pneumonia * 1 [1]  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%)  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Scrotal gangrene * 1 [1]  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Urinary tract infection * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%)  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Urosepsis * 1 [1]  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%)  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Injury, poisoning and procedural complications             
Ankle fracture * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Road traffic accident * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Wound complication * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%)  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Metabolism and nutrition disorders             
Diabetic ketoacidosis * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia * 1 [1]  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%)  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Musculoskeletal chest pain * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%)  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Spinal osteoarthritis * 1 [1]  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Back pain * 1 [1]  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Colon cancer * 1 [1]  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Nervous system disorders             
Cerebrovascular accident * 1 [1]  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%)  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Renal and urinary disorders             
Nephrolithiasis * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Urinary incontinence * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Calculus ureteric * 1 [1]  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%)  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Hydronephrosis * 1 [1]  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%)  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Reproductive system and breast disorders             
Uterine enlargement * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  1/156 (0.64%)  0/157 (0.00%)  0/156 (0.00%) 
Uterine prolapse * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  0/156 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Skin and subcutaneous tissue disorders             
Skin ulcer * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%)  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Vascular disorders             
Deep vein thrombosis * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%)  0/156 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MEDDRA 14.0/15.0
[1]
Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo: Baseline to Week 26 Canagliflozin 100 mg: Baseline to Week 26 Canagliflozin 300 mg: Baseline to Week 26 Placebo: Baseline to Week 52 Canagliflozin 100 mg: Baseline to Week 52 Canagliflozin 300 mg: Baseline to Week 52
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/156 (19.87%)   42/157 (26.75%)   38/156 (24.36%)   52/156 (33.33%)   63/157 (40.13%)   54/156 (34.62%) 
Gastrointestinal disorders             
Diarrhoea * 1 [1]  5/156 (3.21%)  5/157 (3.18%)  10/156 (6.41%)  5/156 (3.21%)  8/157 (5.10%)  11/156 (7.05%) 
Infections and infestations             
Influenza * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  8/156 (5.13%)  4/157 (2.55%)  8/156 (5.13%) 
Sinusitis * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  3/156 (1.92%)  8/157 (5.10%)  3/156 (1.92%) 
Nasopharyngitis * 1 [1]  4/156 (2.56%)  6/157 (3.82%)  8/156 (5.13%)  10/156 (6.41%)  9/157 (5.73%)  9/156 (5.77%) 
Upper respiratory tract infection * 1 [1]  10/156 (6.41%)  17/157 (10.83%)  6/156 (3.85%)  13/156 (8.33%)  21/157 (13.38%)  9/156 (5.77%) 
Urinary tract infection * 1 [1]  8/156 (5.13%)  9/157 (5.73%)  7/156 (4.49%)  12/156 (7.69%)  12/157 (7.64%)  9/156 (5.77%) 
Vulvovaginal mycotic infection * 1 [1]  2/156 (1.28%)  8/157 (5.10%)  8/156 (5.13%)  2/156 (1.28%)  9/157 (5.73%)  8/156 (5.13%) 
Metabolism and nutrition disorders             
Hypoglycaemia * 1 [1]  6/156 (3.85%)  11/157 (7.01%)  9/156 (5.77%)  9/156 (5.77%)  13/157 (8.28%)  11/156 (7.05%) 
Musculoskeletal and connective tissue disorders             
Arthralgia * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  8/156 (5.13%)  8/157 (5.10%)  8/156 (5.13%) 
Nervous system disorders             
Headache * 1 [1]  0/156 (0.00%)  0/157 (0.00%)  0/156 (0.00%)  5/156 (3.21%)  11/157 (7.01%)  2/156 (1.28%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MEDDRA 14.0/15.0
[1]
Source vocabulary is MEDDRA 14.0 for Week 26 and MEDDRA 15.0 for Week 52.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
Organization: Janssen Research & Development, LLC
Phone: 1 800 526 7736
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01106625    
Other Study ID Numbers: CR017005
28431754DIA3002 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: April 1, 2010
First Posted: April 20, 2010
Results First Submitted: April 10, 2013
Results First Posted: May 29, 2013
Last Update Posted: June 20, 2013