Trial Outcomes & Findings for 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 (NCT NCT01939496)
NCT ID: NCT01939496
Last Updated: 2017-03-03
Results Overview
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
171 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2017-03-03
Participant Flow
A total of 504 participants were screened. Of which, 171 participants were randomized to study treatment. 2 participants were randomized but not dosed.
Participant milestones
| Measure |
Placebo
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
57
|
56
|
|
Overall Study
COMPLETED
|
47
|
54
|
54
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Blood Pressure Withdrawal Criteria
|
0
|
1
|
0
|
|
Overall Study
Other
|
2
|
0
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 8.74 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 6.88 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 8.44 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: 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.
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
Baseline (n=56,57,56)
|
136.7 millimeter of mercury (mmHg)
Standard Deviation 10.293
|
136.5 millimeter of mercury (mmHg)
Standard Deviation 11.501
|
139.6 millimeter of mercury (mmHg)
Standard Deviation 10.925
|
|
Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
Change From Baseline at Week 6 (n=54,54,55)
|
-1.26 millimeter of mercury (mmHg)
Standard Deviation 9.864
|
-4.78 millimeter of mercury (mmHg)
Standard Deviation 8.327
|
-7.31 millimeter of mercury (mmHg)
Standard Deviation 11.409
|
SECONDARY outcome
Timeframe: Baseline and Day 2Population: 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.
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
Baseline (n=56,57,56)
|
136.7 millimeter of mercury (mmHg)
Standard Deviation 10.293
|
136.5 millimeter of mercury (mmHg)
Standard Deviation 11.501
|
139.6 millimeter of mercury (mmHg)
Standard Deviation 10.925
|
|
Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
Change From Baseline at Day 2 (n=50,50,50)
|
0.49 millimeter of mercury (mmHg)
Standard Deviation 8.592
|
-1.78 millimeter of mercury (mmHg)
Standard Deviation 6.924
|
-1.97 millimeter of mercury (mmHg)
Standard Deviation 7.343
|
SECONDARY outcome
Timeframe: Baseline, Day 2 and Week 6Population: 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.
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Baseline (n=56,57,56)
|
78.36 millimeter of mercury (mmHg)
Standard Deviation 7.330
|
78.01 millimeter of mercury (mmHg)
Standard Deviation 8.093
|
79.31 millimeter of mercury (mmHg)
Standard Deviation 7.899
|
|
Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Change From Baseline at Day 2 (n=50,50,50)
|
1.01 millimeter of mercury (mmHg)
Standard Deviation 5.197
|
-0.85 millimeter of mercury (mmHg)
Standard Deviation 4.155
|
-0.45 millimeter of mercury (mmHg)
Standard Deviation 4.540
|
|
Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Change From Baseline at Week 6 (n=54,54,55)
|
-0.26 millimeter of mercury (mmHg)
Standard Deviation 5.345
|
-2.18 millimeter of mercury (mmHg)
Standard Deviation 4.870
|
-3.27 millimeter of mercury (mmHg)
Standard Deviation 6.462
|
SECONDARY outcome
Timeframe: Baseline, Day 2 and Week 6Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Baseline (n=56,57,56)
|
139.4 millimeter of mercury (mmHg)
Standard Deviation 10.343
|
139.6 millimeter of mercury (mmHg)
Standard Deviation 11.295
|
142.8 millimeter of mercury (mmHg)
Standard Deviation 11.435
|
|
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Change From Baseline at Day 2 (n=50,50,50)
|
0.96 millimeter of mercury (mmHg)
Standard Deviation 9.494
|
-2.06 millimeter of mercury (mmHg)
Standard Deviation 7.309
|
-1.16 millimeter of mercury (mmHg)
Standard Deviation 7.579
|
|
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Change From Baseline at Week 6 (n=54,54,55)
|
-0.65 millimeter of mercury (mmHg)
Standard Deviation 9.874
|
-5.05 millimeter of mercury (mmHg)
Standard Deviation 8.656
|
-7.36 millimeter of mercury (mmHg)
Standard Deviation 11.660
|
SECONDARY outcome
Timeframe: Baseline, Day 2 and Week 6Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Baseline (n=56,57,56)
|
80.84 millimeter of mercury (mmHg)
Standard Deviation 7.656
|
80.53 millimeter of mercury (mmHg)
Standard Deviation 8.252
|
81.81 millimeter of mercury (mmHg)
Standard Deviation 8.377
|
|
Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Change From Baseline at Day 2 (n=50,50,50)
|
1.21 millimeter of mercury (mmHg)
Standard Deviation 5.579
|
-1.08 millimeter of mercury (mmHg)
Standard Deviation 4.519
|
0.03 millimeter of mercury (mmHg)
Standard Deviation 4.772
|
|
Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Change From Baseline at Week 6 (n=54,54,55)
|
-0.20 millimeter of mercury (mmHg)
Standard Deviation 5.257
|
-2.39 millimeter of mercury (mmHg)
Standard Deviation 5.413
|
-3.23 millimeter of mercury (mmHg)
Standard Deviation 6.557
|
SECONDARY outcome
Timeframe: Baseline, Day 2 and Week 6Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Baseline (n=56,57,56)
|
129.3 millimeter of mercury (mmHg)
Standard Deviation 12.128
|
128.3 millimeter of mercury (mmHg)
Standard Deviation 14.527
|
130.2 millimeter of mercury (mmHg)
Standard Deviation 12.727
|
|
Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Change From Baseline at Day 2 (n=50,50,50)
|
-0.19 millimeter of mercury (mmHg)
Standard Deviation 8.801
|
-1.02 millimeter of mercury (mmHg)
Standard Deviation 8.723
|
-4.37 millimeter of mercury (mmHg)
Standard Deviation 10.682
|
|
Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Change From Baseline at Week 6 (n=54,54,55)
|
-3.49 millimeter of mercury (mmHg)
Standard Deviation 12.469
|
-4.33 millimeter of mercury (mmHg)
Standard Deviation 11.506
|
-6.98 millimeter of mercury (mmHg)
Standard Deviation 12.880
|
SECONDARY outcome
Timeframe: Baseline, Day 2 and Week 6Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Baseline (n=56,57,56)
|
71.57 millimeter of mercury (mmHg)
Standard Deviation 8.100
|
71.10 millimeter of mercury (mmHg)
Standard Deviation 9.091
|
72.31 millimeter of mercury (mmHg)
Standard Deviation 8.515
|
|
Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Change From Baseline at Day 2 (n=50,50,50)
|
0.87 millimeter of mercury (mmHg)
Standard Deviation 6.282
|
-0.23 millimeter of mercury (mmHg)
Standard Deviation 5.764
|
-2.24 millimeter of mercury (mmHg)
Standard Deviation 6.037
|
|
Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Change From Baseline at Week 6 (n=54,54,55)
|
-0.98 millimeter of mercury (mmHg)
Standard Deviation 7.749
|
-1.73 millimeter of mercury (mmHg)
Standard Deviation 6.475
|
-3.42 millimeter of mercury (mmHg)
Standard Deviation 8.056
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: 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.
The fasting plasma glucose was evaluated.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6
Baseline (n=56,57,56)
|
9.84 millimoles per liter (mmol/L)
Standard Deviation 2.435
|
9.69 millimoles per liter (mmol/L)
Standard Deviation 2.085
|
9.38 millimoles per liter (mmol/L)
Standard Deviation 2.000
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6
Change From Baseline at Week 6 (n=55,54,55)
|
-0.38 millimoles per liter (mmol/L)
Standard Deviation 2.727
|
-0.03 millimoles per liter (mmol/L)
Standard Deviation 2.702
|
-1.27 millimoles per liter (mmol/L)
Standard Deviation 2.164
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: 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.
Body weight was evaluated.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Body Weight to Week 6
Change From Baseline at Week 6 (n=54,55,56)
|
0.14 Kilogram (kg)
Standard Deviation 2.326
|
-0.98 Kilogram (kg)
Standard Deviation 1.964
|
-1.47 Kilogram (kg)
Standard Deviation 2.160
|
|
Change From Baseline in Body Weight to Week 6
Baseline (n=56,57,56)
|
91.65 Kilogram (kg)
Standard Deviation 17.525
|
95.32 Kilogram (kg)
Standard Deviation 22.201
|
96.06 Kilogram (kg)
Standard Deviation 20.227
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Week 3 and 6Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
SBP: Baseline (n=56,57,56)
|
137.7 millimeter of mercury (mmHg)
Standard Deviation 8.581
|
138.5 millimeter of mercury (mmHg)
Standard Deviation 11.102
|
139.2 millimeter of mercury (mmHg)
Standard Deviation 8.832
|
|
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
SBP: Change From Baseline at Day 2 (n=55,57,56)
|
-3.24 millimeter of mercury (mmHg)
Standard Deviation 10.045
|
-2.06 millimeter of mercury (mmHg)
Standard Deviation 8.971
|
-5.11 millimeter of mercury (mmHg)
Standard Deviation 8.768
|
|
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
SBP: Change From Baseline at Week 3 (n=55,57,56)
|
-5.95 millimeter of mercury (mmHg)
Standard Deviation 10.373
|
-7.53 millimeter of mercury (mmHg)
Standard Deviation 10.825
|
-10.6 millimeter of mercury (mmHg)
Standard Deviation 11.340
|
|
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
SBP: Change From Baseline at Week 6 (n=55,57,56)
|
-3.36 millimeter of mercury (mmHg)
Standard Deviation 13.807
|
-4.98 millimeter of mercury (mmHg)
Standard Deviation 11.430
|
-7.38 millimeter of mercury (mmHg)
Standard Deviation 16.248
|
|
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
DBP: Baseline (n=55,57,56)
|
82.67 millimeter of mercury (mmHg)
Standard Deviation 8.571
|
82.37 millimeter of mercury (mmHg)
Standard Deviation 7.673
|
83.02 millimeter of mercury (mmHg)
Standard Deviation 8.155
|
|
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
DBP: Change From Baseline at Day 2 (n=55,57,56)
|
-2.61 millimeter of mercury (mmHg)
Standard Deviation 6.259
|
-0.26 millimeter of mercury (mmHg)
Standard Deviation 6.217
|
-0.87 millimeter of mercury (mmHg)
Standard Deviation 5.688
|
|
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
DBP: Change From Baseline at Week 3 (n=55,57,56)
|
-2.84 millimeter of mercury (mmHg)
Standard Deviation 6.664
|
-2.22 millimeter of mercury (mmHg)
Standard Deviation 6.226
|
-4.23 millimeter of mercury (mmHg)
Standard Deviation 6.267
|
|
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
DBP: Change From Baseline at Week 6 (n=55,57,56)
|
-1.78 millimeter of mercury (mmHg)
Standard Deviation 9.271
|
-1.52 millimeter of mercury (mmHg)
Standard Deviation 6.652
|
-2.43 millimeter of mercury (mmHg)
Standard Deviation 7.479
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Week 3 and 6Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
SBP: Baseline (n=56,57,56)
|
140.3 millimeter of mercury (mmHg)
Standard Deviation 10.067
|
139.3 millimeter of mercury (mmHg)
Standard Deviation 11.801
|
140.8 millimeter of mercury (mmHg)
Standard Deviation 9.058
|
|
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
DBP: Baseline (n=55,57,56)
|
85.79 millimeter of mercury (mmHg)
Standard Deviation 8.608
|
85.25 millimeter of mercury (mmHg)
Standard Deviation 8.354
|
86.09 millimeter of mercury (mmHg)
Standard Deviation 7.349
|
|
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
SBP: Change From Baseline at Day 2 (n=55,57,56)
|
-4.36 millimeter of mercury (mmHg)
Standard Deviation 10.293
|
-2.46 millimeter of mercury (mmHg)
Standard Deviation 12.133
|
-5.91 millimeter of mercury (mmHg)
Standard Deviation 11.617
|
|
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
SBP: Change From Baseline at Week 3 (n=55,57,56)
|
-6.55 millimeter of mercury (mmHg)
Standard Deviation 13.178
|
-7.12 millimeter of mercury (mmHg)
Standard Deviation 12.503
|
-11.9 millimeter of mercury (mmHg)
Standard Deviation 14.226
|
|
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
SBP: Change From Baseline at Week 6 (n=55,57,56)
|
-3.76 millimeter of mercury (mmHg)
Standard Deviation 17.651
|
-7.95 millimeter of mercury (mmHg)
Standard Deviation 13.722
|
-11.3 millimeter of mercury (mmHg)
Standard Deviation 16.872
|
|
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
DBP: Change From Baseline at Day 2 (n=55,57,56)
|
-0.65 millimeter of mercury (mmHg)
Standard Deviation 8.945
|
-0.60 millimeter of mercury (mmHg)
Standard Deviation 8.914
|
-1.32 millimeter of mercury (mmHg)
Standard Deviation 7.515
|
|
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
DBP: Change From Baseline at Week 3 (n=55,57,56)
|
-2.91 millimeter of mercury (mmHg)
Standard Deviation 8.341
|
-3.47 millimeter of mercury (mmHg)
Standard Deviation 7.117
|
-5.36 millimeter of mercury (mmHg)
Standard Deviation 6.632
|
|
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
DBP: Change From Baseline at Week 6 (n=55,57,56)
|
-0.89 millimeter of mercury (mmHg)
Standard Deviation 9.875
|
-2.51 millimeter of mercury (mmHg)
Standard Deviation 7.280
|
-4.55 millimeter of mercury (mmHg)
Standard Deviation 8.052
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Week 3 and 6Population: 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.
The seated heart rate was evaluated.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Baseline (n=56,57,56)
|
79.57 beats per minute
Standard Deviation 14.597
|
75.05 beats per minute
Standard Deviation 8.574
|
78.13 beats per minute
Standard Deviation 11.060
|
|
Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Change From Baseline at Day 2 (n=55,57,56)
|
-1.40 beats per minute
Standard Deviation 15.412
|
3.05 beats per minute
Standard Deviation 7.909
|
1.68 beats per minute
Standard Deviation 9.219
|
|
Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Change From Baseline at Week 3 (n=55,57,56)
|
-2.24 beats per minute
Standard Deviation 15.412
|
1.70 beats per minute
Standard Deviation 7.305
|
-0.89 beats per minute
Standard Deviation 8.800
|
|
Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Change From Baseline at Week 6 (n=55,57,56)
|
-2.24 beats per minute
Standard Deviation 14.004
|
1.07 beats per minute
Standard Deviation 8.351
|
-1.16 beats per minute
Standard Deviation 8.083
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Week 3 and 6Population: 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.
The standing heart rate was evaluated.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Baseline (n=56,57,56)
|
82.54 beats per minute
Standard Deviation 8.826
|
78.65 beats per minute
Standard Deviation 9.259
|
81.86 beats per minute
Standard Deviation 11.949
|
|
Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Change From Baseline at Day 2 (n=55,57,56)
|
0.27 beats per minute
Standard Deviation 8.350
|
4.32 beats per minute
Standard Deviation 8.403
|
2.79 beats per minute
Standard Deviation 9.689
|
|
Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Change From Baseline at Week 3 (n=55,57,56)
|
-0.89 beats per minute
Standard Deviation 10.322
|
3.47 beats per minute
Standard Deviation 9.383
|
0.48 beats per minute
Standard Deviation 9.217
|
|
Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Change From Baseline at Week 6 (n=55,57,56)
|
-0.07 beats per minute
Standard Deviation 9.465
|
1.44 beats per minute
Standard Deviation 9.200
|
-0.68 beats per minute
Standard Deviation 8.547
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Week 3 and 6Population: 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.
The difference in seated office blood pressure and standing office blood pressure was evaluated.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
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
Baseline (n=56,57,56)
|
2.65 millimeter of mercury (mmHg)
Standard Deviation 7.914
|
0.78 millimeter of mercury (mmHg)
Standard Deviation 8.964
|
1.55 millimeter of mercury (mmHg)
Standard Deviation 8.231
|
|
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
Change From Baseline at Day 2 (n=55,57,56)
|
-1.13 millimeter of mercury (mmHg)
Standard Deviation 10.991
|
-0.39 millimeter of mercury (mmHg)
Standard Deviation 11.097
|
-0.80 millimeter of mercury (mmHg)
Standard Deviation 9.078
|
|
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
Change From Baseline at Week 3 (n=55,57,56)
|
-0.60 millimeter of mercury (mmHg)
Standard Deviation 10.921
|
0.40 millimeter of mercury (mmHg)
Standard Deviation 8.562
|
-1.27 millimeter of mercury (mmHg)
Standard Deviation 9.873
|
|
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
Change From Baseline at Week 6 (n=55,57,56)
|
-0.41 millimeter of mercury (mmHg)
Standard Deviation 11.875
|
-2.96 millimeter of mercury (mmHg)
Standard Deviation 8.397
|
-3.90 millimeter of mercury (mmHg)
Standard Deviation 11.566
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Week 3 and 6Population: 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.
The difference in seated heart rate and standing heart rate was evaluated.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 Participants
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 Participants
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
Change From Baseline at Week 6 (n=55,57,56)
|
2.16 beats per minute
Standard Deviation 15.975
|
0.37 beats per minute
Standard Deviation 7.203
|
0.48 beats per minute
Standard Deviation 4.472
|
|
Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
Baseline (n=56,57,56)
|
2.96 beats per minute
Standard Deviation 14.752
|
3.60 beats per minute
Standard Deviation 5.168
|
3.73 beats per minute
Standard Deviation 4.232
|
|
Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
Change From Baseline at Day 2 (n=55,57,56)
|
1.67 beats per minute
Standard Deviation 14.562
|
1.26 beats per minute
Standard Deviation 6.802
|
1.11 beats per minute
Standard Deviation 5.786
|
|
Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
Change From Baseline at Week 3 (n=55,57,56)
|
1.35 beats per minute
Standard Deviation 16.008
|
1.77 beats per minute
Standard Deviation 6.538
|
1.38 beats per minute
Standard Deviation 5.262
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Canagliflozin 100 Milligram (mg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Canagliflozin 300 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=56 participants at risk
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 participants at risk
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 participants at risk
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
1.8%
1/56 • Screening up to post-treatment Phase (30 days after the last dose of study medication)
|
0.00%
0/57 • Screening up to post-treatment Phase (30 days after the last dose of study medication)
|
0.00%
0/56 • Screening up to post-treatment Phase (30 days after the last dose of study medication)
|
Other adverse events
| Measure |
Placebo
n=56 participants at risk
Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 100 Milligram (mg)
n=57 participants at risk
Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
|
Canagliflozin 300 mg
n=56 participants at risk
Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/56 • Screening up to post-treatment Phase (30 days after the last dose of study medication)
|
5.3%
3/57 • Screening up to post-treatment Phase (30 days after the last dose of study medication)
|
0.00%
0/56 • Screening up to post-treatment Phase (30 days after the last dose of study medication)
|
|
Renal and urinary disorders
Pollakiuria
|
1.8%
1/56 • Screening up to post-treatment Phase (30 days after the last dose of study medication)
|
1.8%
1/57 • Screening up to post-treatment Phase (30 days after the last dose of study medication)
|
5.4%
3/56 • Screening up to post-treatment Phase (30 days after the last dose of study medication)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER