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Trial record 1 of 1 for:    NCT01081834
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The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

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: NCT01081834
Recruitment Status : Completed
First Posted : March 5, 2010
Results First Posted : June 3, 2013
Last Update Posted : February 23, 2017
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: Sitagliptin
Enrollment 678
Recruitment Details This study evaluated the efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. The study was conducted between 08 February 2010 and 18 August 2011 and recruited patients from 90 study centers in 17 countries worldwide.
Pre-assignment Details 678 patients were enrolled into the study; 587 patients in the main study and 91 patients in the high glycemic substudy. 584 patients in the main study and all 91 patients in the high glycemic substudy received at least one dose of study drug and were included in the modified intent-to-treat (mITT) analyses sets and the safety analyses sets.
Arm/Group Title Main Study: Placebo/Sitagliptin Main Study: Canagliflozin 100 mg Main Study: Canagliflozin 300 mg High Glycemic Substudy: Canagliflozin 100 mg High Glycemic Substudy: Canagliflozin 300 mg
Hide Arm/Group Description In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks. In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks. In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52. In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.
Period Title: Core Period: Baseline to Week 26
Started 192 195 197 47 44
Completed 160 172 175 40 40
Not Completed 32 23 22 7 4
Reason Not Completed
Pregnancy             1             0             0             0             0
Adverse Event             2             5             3             1             1
Death             1             0             0             0             0
Lost to Follow-up             2             2             5             0             0
Protocol Violation             0             4             0             0             2
Withdrawal by Subject             15             3             9             3             1
Noncompliance with study drug             3             4             2             2             0
Unable to take rescue therapy             1             0             0             0             0
Other             4             4             3             1             0
Lack of efficacy on rescue therapy             3             1             0             0             0
Period Title: Extension Period: Week 26 to Week 52
Started 155 [1] 170 [2] 170 [3] 0 [4] 0 [4]
Completed 135 152 165 0 0
Not Completed 20 18 5 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0
Death             1             0             0             0             0
Lost to Follow-up             4             4             0             0             0
Protocol Violation             0             1             0             0             0
Withdrawal by Subject             1             2             0             0             0
Unable to take rescue therapy             1             0             1             0             0
Creatinine or eGFR withdrawal criteria             1             4             0             0             0
Other             4             5             4             0             0
Lack of efficacy on rescue therapy             7             1             0             0             0
Physician Decision             0             1             0             0             0
[1]
5 pts discontinued on last day of core: lack of efficacy on rescue (2), not specified (NS) (3).
[2]
2 pts discontinued on last day of core: adverse event (AE) (1), protocol violation (PV) (1).
[3]
5 pts discontinued last day of core: AE (1), lost f/u (1), PV (1), NS (1), physician decision (1).
[4]
The treatment duration for the High Glycemic Substudy was 26 weeks only.
Arm/Group Title Main Study: Placebo/Sitagliptin Main Study: Canagliflozin 100 mg Main Study: Canagliflozin 300 mg High Glycemic Substudy: Canagliflozin 100 mg High Glycemic Substudy: Canagliflozin 300 mg Total
Hide Arm/Group Description In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks. In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks. In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks. In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks. Total of all reporting groups
Overall Number of Baseline Participants 192 195 197 47 44 675
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 195 participants 197 participants 47 participants 44 participants 675 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
150
  78.1%
156
  80.0%
160
  81.2%
42
  89.4%
41
  93.2%
549
  81.3%
>=65 years
42
  21.9%
39
  20.0%
37
  18.8%
5
  10.6%
3
   6.8%
126
  18.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 192 participants 195 participants 197 participants 47 participants 44 participants 675 participants
55.7  (10.88) 55.1  (10.83) 55.3  (10.17) 49.7  (11.12) 48.8  (10.92) 54.5  (10.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 195 participants 197 participants 47 participants 44 participants 675 participants
Female
104
  54.2%
114
  58.5%
108
  54.8%
24
  51.1%
25
  56.8%
375
  55.6%
Male
88
  45.8%
81
  41.5%
89
  45.2%
23
  48.9%
19
  43.2%
300
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 192 participants 195 participants 197 participants 47 participants 44 participants 675 participants
AUSTRIA 1 2 1 0 0 4
COLOMBIA 8 8 6 3 0 25
ESTONIA 6 5 5 0 0 16
GUATEMALA 10 10 13 9 10 52
ICELAND 4 4 8 2 2 20
INDIA 8 11 8 5 2 34
LITHUANIA 17 10 12 2 1 42
MALAYSIA 6 2 7 1 0 16
MEXICO 19 23 19 2 2 65
PHILIPPINES 3 4 6 4 4 21
POLAND 1 4 3 0 0 8
ROMANIA 20 16 18 2 4 60
SOUTH AFRICA 9 6 11 1 2 29
SOUTH KOREA 10 8 7 1 1 27
SPAIN 3 2 3 0 0 8
SWEDEN 11 18 18 0 1 48
UNITED STATES 56 62 52 15 15 200
1.Primary Outcome
Title Change in HbA1c From Baseline to Week 26 (Main Study)
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:
In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
Overall Number of Participants Analyzed 189 191 194
Least Squares Mean (Standard Error)
Unit of Measure: Percent
0.14  (0.065) -0.77  (0.065) -1.03  (0.064)
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 -0.91
Confidence Interval (2-Sided) 95%
-1.088 to -0.729
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.091
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 -1.16
Confidence Interval (2-Sided) 95%
-1.342 to -0.985
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.091
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)
Hide Description The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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:
In the High Glycemic Substudy, no patients received placebo.
In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
Overall Number of Participants Analyzed 0 46 43
Least Squares Mean (Standard Error)
Unit of Measure: Percent
-2.13  (0.220) -2.56  (0.227)
3.Secondary Outcome
Title Percentage of Patients With HbA1c <7% at Week 26 (Main Study)
Hide Description The table below shows the percentage of patients with HbA1c <7% at Week 26. 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:
In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
Overall Number of Participants Analyzed 189 191 194
Measure Type: Number
Unit of Measure: Percentage of patients
20.6 44.5 62.4
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 5.34
Confidence Interval (2-Sided) 95%
3.10 to 9.23
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 14.61
Confidence Interval (2-Sided) 95%
8.14 to 26.25
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study)
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:
In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
Overall Number of Participants Analyzed 184 188 192
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
8.33  (2.448) -27.2  (2.412) -35.0  (2.391)
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 -35.5
Confidence Interval (2-Sided) 95%
-42.22 to -28.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.420
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 -43.4
Confidence Interval (2-Sided) 95%
-50.06 to -36.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.402
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)
Hide Description The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose 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:
In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
Overall Number of Participants Analyzed 126 154 157
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
5.19  (4.204) -42.9  (3.763) -58.8  (3.741)
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 -49.1
Confidence Interval (2-Sided) 95%
-59.12 to -36.99
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.629
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 -64.0
Confidence Interval (2-Sided) 95%
-75.02 to -52.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.616
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change in Body Weight From Baseline to Week 26 (Main Study)
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:
In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
Overall Number of Participants Analyzed 190 192 194
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
-0.6  (0.2) -2.8  (0.2) -3.9  (0.2)
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 <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-2.9 to -1.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3
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 -3.3
Confidence Interval (2-Sided) 95%
-4.0 to -2.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)
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:
In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
Overall Number of Participants Analyzed 190 192 195
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
0.38  (0.780) -3.34  (0.775) -5.04  (0.769)
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 -3.71
Confidence Interval (2-Sided) 95%
-5.860 to -1.568
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.093
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 -5.42
Confidence Interval (2-Sided) 95%
-7.556 to -3.280
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.088
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percent Change in Triglycerides From Baseline to Week 26 (Main Study)
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:
In the Main study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
Overall Number of Participants Analyzed 171 183 183
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
7.8  (3.5) 2.5  (3.3) -2.4  (3.3)
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 0.267
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -5.3
Confidence Interval (2-Sided) 95%
-14.8 to 4.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.8
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 0.034
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value -10.2
Confidence Interval (2-Sided) 95%
-19.6 to -0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.8
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)
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:
In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
Overall Number of Participants Analyzed 170 182 183
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
4.4  (1.4) 11.2  (1.4) 10.5  (1.4)
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 6.7
Confidence Interval (2-Sided) 95%
2.9 to 10.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.9
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 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Squares Mean Difference
Estimated Value 6.0
Confidence Interval (2-Sided) 95%
2.2 to 9.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.9
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)
Hide Description The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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:
In the High Glycemic Substudy, no patients received placebo.
In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
Overall Number of Participants Analyzed 0 46 43
Measure Type: Number
Unit of Measure: Percentage of patients
17.4 11.6
11.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)
Hide Description The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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:
In the High Glycemic Substudy, no patients received placebo.
In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
Overall Number of Participants Analyzed 0 45 43
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-81.7  (6.459) -86.3  (6.553)
12.Secondary Outcome
Title Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)
Hide Description The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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:
In the High Glycemic Substudy, no patients received placebo.
In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
Overall Number of Participants Analyzed 0 30 34
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-118  (10.179) -126  (9.437)
13.Secondary Outcome
Title Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)
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 in patients randomized to the High Glycemic Substudy.
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:
In the High Glycemic Substudy, no patients received placebo.
In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
Overall Number of Participants Analyzed 0 46 43
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
-3.0  (0.6) -3.8  (0.6)
14.Secondary Outcome
Title Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)
Hide Description The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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:
In the High Glycemic Substudy, no patients received placebo.
In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
Overall Number of Participants Analyzed 0 46 43
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-4.47  (1.754) -4.97  (1.800)
15.Secondary Outcome
Title Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)
Hide Description The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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:
In the High Glycemic Substudy, no patients received placebo.
In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
Overall Number of Participants Analyzed 0 44 43
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
-0.6  (7.4) -12.7  (7.5)
16.Secondary Outcome
Title Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)
Hide Description The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.
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:
In the High Glycemic Substudy, no patients received placebo.
In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
In the High Glycemic substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
Overall Number of Participants Analyzed 0 44 43
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
2.4  (2.9) 10.8  (2.9)
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 Main Study (Baseline to Week 26): Placebo Main Study (Baseline to Week 26): Cana 100 mg Main Study (Baseline to Week 26): Cana 300 mg Main Study (Baseline to Week 52): Placebo/Sitagliptin Main Study (Baseline to Week 52): Cana 100 mg Main Study (Baseline to Week 52): Cana 300 mg High Glycemic Substudy (Baseline to Week 26): Cana 100 mg High Glycemic Substudy (Baseline to Week 26): Cana 300 mg
Hide Arm/Group Description Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 26. Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26. Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26. Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 52. Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52. Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52. Each patient received 100 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26. Each patient received 300 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.
All-Cause Mortality
Main Study (Baseline to Week 26): Placebo Main Study (Baseline to Week 26): Cana 100 mg Main Study (Baseline to Week 26): Cana 300 mg Main Study (Baseline to Week 52): Placebo/Sitagliptin Main Study (Baseline to Week 52): Cana 100 mg Main Study (Baseline to Week 52): Cana 300 mg High Glycemic Substudy (Baseline to Week 26): Cana 100 mg High Glycemic Substudy (Baseline to Week 26): Cana 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Main Study (Baseline to Week 26): Placebo Main Study (Baseline to Week 26): Cana 100 mg Main Study (Baseline to Week 26): Cana 300 mg Main Study (Baseline to Week 52): Placebo/Sitagliptin Main Study (Baseline to Week 52): Cana 100 mg Main Study (Baseline to Week 52): Cana 300 mg High Glycemic Substudy (Baseline to Week 26): Cana 100 mg High Glycemic Substudy (Baseline to Week 26): Cana 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/192 (2.08%)   8/195 (4.10%)   2/197 (1.02%)   11/192 (5.73%)   11/195 (5.64%)   5/197 (2.54%)   0/47 (0.00%)   1/44 (2.27%) 
Cardiac disorders                 
Coronary artery disease * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Myocardial infarction * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Pericardial effusion * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Gastrointestinal disorders                 
Abdominal pain * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Intestinal obstruction * 1  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Nausea * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Vomiting * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Abdominal hernia * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Inguinal hernia * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  0/192 (0.00%)  0/195 (0.00%)  1/197 (0.51%)  0/47 (0.00%)  0/44 (0.00%) 
Umbilical hernia * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Hepatobiliary disorders                 
Ischaemic hepatitis * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Liver disorder * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Infections and infestations                 
Abscess limb * 1  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Bacterial prostatitis * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Cellulitis * 1  1/192 (0.52%)  1/195 (0.51%)  0/197 (0.00%)  1/192 (0.52%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Diverticulitis * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Pneumonia * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Septic shock * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Appendicitis * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  0/192 (0.00%)  0/195 (0.00%)  1/197 (0.51%)  0/47 (0.00%)  0/44 (0.00%) 
Gastrointestinal infection * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Pulmonary tuberculosis * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Viral pericarditis * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Injury, poisoning and procedural complications                 
Ankle fracture * 1  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Brain herniation * 1  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Wound * 1  0/192 (0.00%)  0/195 (0.00%)  1/197 (0.51%)  0/192 (0.00%)  0/195 (0.00%)  1/197 (0.51%)  0/47 (0.00%)  0/44 (0.00%) 
Skeletal injury * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Spinal column injury * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Investigations                 
Hepatic enzyme increased * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  1/44 (2.27%) 
Musculoskeletal and connective tissue disorders                 
Osteoarthritis * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Prostate cancer * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Nervous system disorders                 
Haemorrhage intracranial * 1  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Peripheral sensory neuropathy * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  1/192 (0.52%)  0/195 (0.00%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Renal and urinary disorders                 
Renal colic * 1  0/192 (0.00%)  0/195 (0.00%)  1/197 (0.51%)  0/192 (0.00%)  0/195 (0.00%)  1/197 (0.51%)  0/47 (0.00%)  0/44 (0.00%) 
Renal failure acute * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Pulmonary embolism * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Asthma * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  0/192 (0.00%)  0/195 (0.00%)  1/197 (0.51%)  0/47 (0.00%)  0/44 (0.00%) 
Skin and subcutaneous tissue disorders                 
Urticaria * 1  0/192 (0.00%)  2/195 (1.03%)  0/197 (0.00%)  0/192 (0.00%)  2/195 (1.03%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
Vascular disorders                 
Deep vein thrombosis * 1  0/192 (0.00%)  0/195 (0.00%)  1/197 (0.51%)  0/192 (0.00%)  0/195 (0.00%)  1/197 (0.51%)  0/47 (0.00%)  0/44 (0.00%) 
Thrombosis * 1  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/192 (0.00%)  1/195 (0.51%)  0/197 (0.00%)  0/47 (0.00%)  0/44 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MEDDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Main Study (Baseline to Week 26): Placebo Main Study (Baseline to Week 26): Cana 100 mg Main Study (Baseline to Week 26): Cana 300 mg Main Study (Baseline to Week 52): Placebo/Sitagliptin Main Study (Baseline to Week 52): Cana 100 mg Main Study (Baseline to Week 52): Cana 300 mg High Glycemic Substudy (Baseline to Week 26): Cana 100 mg High Glycemic Substudy (Baseline to Week 26): Cana 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   38/192 (19.79%)   39/195 (20.00%)   51/197 (25.89%)   63/192 (32.81%)   54/195 (27.69%)   69/197 (35.03%)   6/47 (12.77%)   6/44 (13.64%) 
Infections and infestations                 
Nasopharyngitis * 1  10/192 (5.21%)  10/195 (5.13%)  16/197 (8.12%)  15/192 (7.81%)  14/195 (7.18%)  20/197 (10.15%)  2/47 (4.26%)  3/44 (6.82%) 
Upper respiratory tract infection * 1  11/192 (5.73%)  7/195 (3.59%)  9/197 (4.57%)  18/192 (9.38%)  8/195 (4.10%)  14/197 (7.11%)  0/47 (0.00%)  0/44 (0.00%) 
Urinary tract infection * 1  8/192 (4.17%)  14/195 (7.18%)  9/197 (4.57%)  11/192 (5.73%)  16/195 (8.21%)  12/197 (6.09%)  3/47 (6.38%)  2/44 (4.55%) 
Influenza * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  7/192 (3.65%)  12/195 (6.15%)  8/197 (4.06%)  0/47 (0.00%)  0/44 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Back pain * 1  6/192 (3.13%)  5/195 (2.56%)  12/197 (6.09%)  9/192 (4.69%)  5/195 (2.56%)  15/197 (7.61%)  0/47 (0.00%)  0/44 (0.00%) 
Pain in extremity * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  1/47 (2.13%)  3/44 (6.82%) 
Arthralgia * 1  0/192 (0.00%)  0/195 (0.00%)  0/197 (0.00%)  13/192 (6.77%)  10/195 (5.13%)  3/197 (1.52%)  0/47 (0.00%)  0/44 (0.00%) 
Nervous system disorders                 
Headache * 1  7/192 (3.65%)  14/195 (7.18%)  12/197 (6.09%)  12/192 (6.25%)  19/195 (9.74%)  17/197 (8.63%)  0/47 (0.00%)  0/44 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MEDDRA 14.0
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: NCT01081834    
Other Study ID Numbers: CR017011
28431754DIA3005 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: March 4, 2010
First Posted: March 5, 2010
Results First Submitted: April 15, 2013
Results First Posted: June 3, 2013
Last Update Posted: February 23, 2017