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Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents

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ClinicalTrials.gov Identifier: NCT01939496
Recruitment Status : Completed
First Posted : September 11, 2013
Results First Posted : April 6, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Diabetes Mellitus, Type 2
Hypertension
Interventions Drug: Canagliflozin
Drug: Placebo
Enrollment 171
Recruitment Details  
Pre-assignment Details A total of 504 participants were screened. Of which, 171 participants were randomized to study treatment. 2 participants were randomized but not dosed.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Period Title: Overall Study
Started 56 57 56
Completed 47 54 54
Not Completed 9 3 2
Reason Not Completed
Adverse Event             2             0             0
Lost to Follow-up             1             1             0
Physician Decision             1             0             0
Protocol Violation             3             0             0
Withdrawal by Subject             0             1             1
Blood Pressure Withdrawal Criteria             0             1             0
Other             2             0             1
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg Total
Hide Arm/Group Description Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. Total of all reporting groups
Overall Number of Baseline Participants 56 57 56 169
Hide Baseline Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 57 participants 56 participants 169 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  67.9%
46
  80.7%
45
  80.4%
129
  76.3%
>=65 years
18
  32.1%
11
  19.3%
11
  19.6%
40
  23.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 57 participants 56 participants 169 participants
59.6  (9.52) 57.8  (8.74) 58.3  (6.88) 58.6  (8.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 57 participants 56 participants 169 participants
Female
23
  41.1%
23
  40.4%
25
  44.6%
71
  42.0%
Male
33
  58.9%
34
  59.6%
31
  55.4%
98
  58.0%
1.Primary Outcome
Title Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
Hide Description The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using last observation carried forward (LOCF) method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Baseline (n=56,57,56) 136.7  (10.293) 136.5  (11.501) 139.6  (10.925)
Change From Baseline at Week 6 (n=54,54,55) -1.26  (9.864) -4.78  (8.327) -7.31  (11.409)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Canagliflozin 100 Milligram (mg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of Least Square Means
Estimated Value -3.29
Confidence Interval (2-Sided) 95%
-6.743 to 0.163
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.748
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 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of Least Square Means
Estimated Value -4.93
Confidence Interval (2-Sided) 95%
-8.382 to -1.469
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.750
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
Hide Description The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Time Frame Baseline and Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Baseline (n=56,57,56) 136.7  (10.293) 136.5  (11.501) 139.6  (10.925)
Change From Baseline at Day 2 (n=50,50,50) 0.49  (8.592) -1.78  (6.924) -1.97  (7.343)
3.Secondary Outcome
Title Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Hide Description The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Time Frame Baseline, Day 2 and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Baseline (n=56,57,56) 78.36  (7.330) 78.01  (8.093) 79.31  (7.899)
Change From Baseline at Day 2 (n=50,50,50) 1.01  (5.197) -0.85  (4.155) -0.45  (4.540)
Change From Baseline at Week 6 (n=54,54,55) -0.26  (5.345) -2.18  (4.870) -3.27  (6.462)
4.Secondary Outcome
Title Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Hide Description The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Time Frame Baseline, Day 2 and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Baseline (n=56,57,56) 139.4  (10.343) 139.6  (11.295) 142.8  (11.435)
Change From Baseline at Day 2 (n=50,50,50) 0.96  (9.494) -2.06  (7.309) -1.16  (7.579)
Change From Baseline at Week 6 (n=54,54,55) -0.65  (9.874) -5.05  (8.656) -7.36  (11.660)
5.Secondary Outcome
Title Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Hide Description The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Time Frame Baseline, Day 2 and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Baseline (n=56,57,56) 80.84  (7.656) 80.53  (8.252) 81.81  (8.377)
Change From Baseline at Day 2 (n=50,50,50) 1.21  (5.579) -1.08  (4.519) 0.03  (4.772)
Change From Baseline at Week 6 (n=54,54,55) -0.20  (5.257) -2.39  (5.413) -3.23  (6.557)
6.Secondary Outcome
Title Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Hide Description The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Time Frame Baseline, Day 2 and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Baseline (n=56,57,56) 129.3  (12.128) 128.3  (14.527) 130.2  (12.727)
Change From Baseline at Day 2 (n=50,50,50) -0.19  (8.801) -1.02  (8.723) -4.37  (10.682)
Change From Baseline at Week 6 (n=54,54,55) -3.49  (12.469) -4.33  (11.506) -6.98  (12.880)
7.Secondary Outcome
Title Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Hide Description The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Time Frame Baseline, Day 2 and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Baseline (n=56,57,56) 71.57  (8.100) 71.10  (9.091) 72.31  (8.515)
Change From Baseline at Day 2 (n=50,50,50) 0.87  (6.282) -0.23  (5.764) -2.24  (6.037)
Change From Baseline at Week 6 (n=54,54,55) -0.98  (7.749) -1.73  (6.475) -3.42  (8.056)
8.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6
Hide Description The fasting plasma glucose was evaluated.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: millimoles per liter (mmol/L)
Baseline (n=56,57,56) 9.84  (2.435) 9.69  (2.085) 9.38  (2.000)
Change From Baseline at Week 6 (n=55,54,55) -0.38  (2.727) -0.03  (2.702) -1.27  (2.164)
9.Secondary Outcome
Title Change From Baseline in Body Weight to Week 6
Hide Description Body weight was evaluated.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: Kilogram (kg)
Baseline (n=56,57,56) 91.65  (17.525) 95.32  (22.201) 96.06  (20.227)
Change From Baseline at Week 6 (n=54,55,56) 0.14  (2.326) -0.98  (1.964) -1.47  (2.160)
10.Secondary Outcome
Title Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
Hide Description The seated office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.
Time Frame Baseline, Day 2, Week 3 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
SBP: Baseline (n=56,57,56) 137.7  (8.581) 138.5  (11.102) 139.2  (8.832)
SBP: Change From Baseline at Day 2 (n=55,57,56) -3.24  (10.045) -2.06  (8.971) -5.11  (8.768)
SBP: Change From Baseline at Week 3 (n=55,57,56) -5.95  (10.373) -7.53  (10.825) -10.6  (11.340)
SBP: Change From Baseline at Week 6 (n=55,57,56) -3.36  (13.807) -4.98  (11.430) -7.38  (16.248)
DBP: Baseline (n=55,57,56) 82.67  (8.571) 82.37  (7.673) 83.02  (8.155)
DBP: Change From Baseline at Day 2 (n=55,57,56) -2.61  (6.259) -0.26  (6.217) -0.87  (5.688)
DBP: Change From Baseline at Week 3 (n=55,57,56) -2.84  (6.664) -2.22  (6.226) -4.23  (6.267)
DBP: Change From Baseline at Week 6 (n=55,57,56) -1.78  (9.271) -1.52  (6.652) -2.43  (7.479)
11.Secondary Outcome
Title Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
Hide Description The standing office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.
Time Frame Baseline, Day 2, Week 3 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
SBP: Baseline (n=56,57,56) 140.3  (10.067) 139.3  (11.801) 140.8  (9.058)
SBP: Change From Baseline at Day 2 (n=55,57,56) -4.36  (10.293) -2.46  (12.133) -5.91  (11.617)
SBP: Change From Baseline at Week 3 (n=55,57,56) -6.55  (13.178) -7.12  (12.503) -11.9  (14.226)
SBP: Change From Baseline at Week 6 (n=55,57,56) -3.76  (17.651) -7.95  (13.722) -11.3  (16.872)
DBP: Baseline (n=55,57,56) 85.79  (8.608) 85.25  (8.354) 86.09  (7.349)
DBP: Change From Baseline at Day 2 (n=55,57,56) -0.65  (8.945) -0.60  (8.914) -1.32  (7.515)
DBP: Change From Baseline at Week 3 (n=55,57,56) -2.91  (8.341) -3.47  (7.117) -5.36  (6.632)
DBP: Change From Baseline at Week 6 (n=55,57,56) -0.89  (9.875) -2.51  (7.280) -4.55  (8.052)
12.Secondary Outcome
Title Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Hide Description The seated heart rate was evaluated.
Time Frame Baseline, Day 2, Week 3 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: beats per minute
Baseline (n=56,57,56) 79.57  (14.597) 75.05  (8.574) 78.13  (11.060)
Change From Baseline at Day 2 (n=55,57,56) -1.40  (15.412) 3.05  (7.909) 1.68  (9.219)
Change From Baseline at Week 3 (n=55,57,56) -2.24  (15.412) 1.70  (7.305) -0.89  (8.800)
Change From Baseline at Week 6 (n=55,57,56) -2.24  (14.004) 1.07  (8.351) -1.16  (8.083)
13.Secondary Outcome
Title Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Hide Description The standing heart rate was evaluated.
Time Frame Baseline, Day 2, Week 3 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: beats per minute
Baseline (n=56,57,56) 82.54  (8.826) 78.65  (9.259) 81.86  (11.949)
Change From Baseline at Day 2 (n=55,57,56) 0.27  (8.350) 4.32  (8.403) 2.79  (9.689)
Change From Baseline at Week 3 (n=55,57,56) -0.89  (10.322) 3.47  (9.383) 0.48  (9.217)
Change From Baseline at Week 6 (n=55,57,56) -0.07  (9.465) 1.44  (9.200) -0.68  (8.547)
14.Secondary Outcome
Title Change From Baseline in the Difference in Seated Office Blood Pressure (BP) and Standing Office BP to Day 2, to Week 3, and to Week 6
Hide Description The difference in seated office blood pressure and standing office blood pressure was evaluated.
Time Frame Baseline, Day 2, Week 3 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Baseline (n=56,57,56) 2.65  (7.914) 0.78  (8.964) 1.55  (8.231)
Change From Baseline at Day 2 (n=55,57,56) -1.13  (10.991) -0.39  (11.097) -0.80  (9.078)
Change From Baseline at Week 3 (n=55,57,56) -0.60  (10.921) 0.40  (8.562) -1.27  (9.873)
Change From Baseline at Week 6 (n=55,57,56) -0.41  (11.875) -2.96  (8.397) -3.90  (11.566)
15.Secondary Outcome
Title Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
Hide Description The difference in seated heart rate and standing heart rate was evaluated.
Time Frame Baseline, Day 2, Week 3 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, "n" specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description:
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Overall Number of Participants Analyzed 56 57 56
Mean (Standard Deviation)
Unit of Measure: beats per minute
Baseline (n=56,57,56) 2.96  (14.752) 3.60  (5.168) 3.73  (4.232)
Change From Baseline at Day 2 (n=55,57,56) 1.67  (14.562) 1.26  (6.802) 1.11  (5.786)
Change From Baseline at Week 3 (n=55,57,56) 1.35  (16.008) 1.77  (6.538) 1.38  (5.262)
Change From Baseline at Week 6 (n=55,57,56) 2.16  (15.975) 0.37  (7.203) 0.48  (4.472)
Time Frame Screening up to post-treatment Phase (30 days after the last dose of study medication)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Hide Arm/Group Description Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
All-Cause Mortality
Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/56 (1.79%)   0/57 (0.00%)   0/56 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Plasma cell myeloma * 1  1/56 (1.79%)  0/57 (0.00%)  0/56 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Canagliflozin 100 Milligram (mg) Canagliflozin 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/56 (1.79%)   4/57 (7.02%)   3/56 (5.36%) 
Infections and infestations       
Nasopharyngitis * 1  0/56 (0.00%)  3/57 (5.26%)  0/56 (0.00%) 
Renal and urinary disorders       
Pollakiuria * 1  1/56 (1.79%)  1/57 (1.75%)  3/56 (5.36%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 17.1
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: Senior Director
Organization: Janssen Scientific Affairs, LLC
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01939496    
Other Study ID Numbers: CR102208
28431754DIA4002 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Submitted: September 6, 2013
First Posted: September 11, 2013
Results First Submitted: March 8, 2016
Results First Posted: April 6, 2016
Last Update Posted: March 3, 2017