Diabetes Mellitus, Type 2, Hypertension
Conditions
Keywords
Diabetes Mellitus, Type 2, Hypertension, Canagliflozin, JNJ 28431754, Sodium-Glucose Transporter 2, Blood Glucose, Type 2 Diabetes Mellitus
Brief summary
The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. Overall safety and tolerability of canagliflozin will be assessed.
Detailed description
This is a randomized (study drug assigned by chance), double blind (neither the patient nor the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the effect of canagliflozin (100 mg and 300 mg) on blood pressure (BP) reduction compared to placebo (a pill that looks like all the other treatments but has no real medicine) in patients with hypertension and type 2 diabetes mellitus (T2DM). The study will consist of 3 phases: a screening phase, a double-blind treatment phase and a follow-up period. Approximately 153 participants will be randomly assigned to 1 of 3 treatment groups (in a 1:1:1 ratio) in the double-blind treatment phase to receive canagliflozin 100 mg, canagliflozin 300 mg or placebo for 6 weeks. The total duration of participation in this study will be approximately 13 weeks.
Interventions
DRUGCanagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
DRUGPlacebo
One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Sponsors
Janssen Scientific Affairs, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients with a diagnosis of type 2 diabetes mellitus * patients with hypertension (seated office SBP of \>=130 mmHg and \<160 mmHg and seated office DBP of \>= 70 mmHg at screening and at Week -2 * patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening * patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening
Exclusion criteria
* a history of diabetic ketoacidosis * type 1 diabetes mellitus (T1DM) * pancreas or beta-cell transplantation * fasting C-peptide \<0.70 ng/mL (0.23 nmol/L) * body mass index \<30 kg/m2 * has ongoing, inadequately controlled thyroid disorder * has a history of cardio-renal disease that required treatment with immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6 | Baseline and Week 6 | The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 | Baseline, Day 2 and Week 6 | The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings. |
| Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6 | Baseline, Day 2 and Week 6 | 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. |
| Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 | Baseline, Day 2 and Week 6 | 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. |
| Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6 | Baseline, Day 2 and Week 6 | 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. |
| Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 | Baseline, Day 2 and Week 6 | 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. |
| Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6 | Baseline and Week 6 | The fasting plasma glucose was evaluated. |
| Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2 | Baseline and Day 2 | The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings. |
| Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6 | Baseline, Day 2, Week 3 and 6 | 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. |
| Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6 | Baseline, Day 2, Week 3 and 6 | 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. |
| Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6 | Baseline, Day 2, Week 3 and 6 | The seated heart rate was evaluated. |
| Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6 | Baseline, Day 2, Week 3 and 6 | The standing heart rate was evaluated. |
| 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, Day 2, Week 3 and 6 | The difference in seated office blood pressure and standing office blood pressure was evaluated. |
| 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, Day 2, Week 3 and 6 | The difference in seated heart rate and standing heart rate was evaluated. |
| Change From Baseline in Body Weight to Week 6 | Baseline and Week 6 | Body weight was evaluated. |
Countries
Puerto Rico, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | 56 |
| Canagliflozin 100 Milligram (mg) Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | 57 |
| Canagliflozin 300 mg Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. | 56 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 |
| Overall Study | Blood Pressure Withdrawal Criteria | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Other | 2 | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 3 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Canagliflozin 100 Milligram (mg) | Canagliflozin 300 mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 11 Participants | 11 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 46 Participants | 45 Participants | 129 Participants |
| Age, Continuous | 59.6 years STANDARD_DEVIATION 9.52 | 57.8 years STANDARD_DEVIATION 8.74 | 58.3 years STANDARD_DEVIATION 6.88 | 58.6 years STANDARD_DEVIATION 8.44 |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 25 Participants | 71 Participants |
| Sex: Female, Male Male | 33 Participants | 34 Participants | 31 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 56 | 4 / 57 | 3 / 56 |
| serious Total, serious adverse events | 1 / 56 | 0 / 57 | 0 / 56 |
Outcome results
Primary
Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6 | Baseline (n=56,57,56) | 136.5 millimeter of mercury (mmHg) | Standard Deviation 11.501 |
| Canagliflozin 100 Milligram (mg) | 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) | -4.78 millimeter of mercury (mmHg) | Standard Deviation 8.327 |
| Canagliflozin 300 mg | Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6 | Baseline (n=56,57,56) | 139.6 millimeter of mercury (mmHg) | Standard Deviation 10.925 |
| Canagliflozin 300 mg | 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) | -7.31 millimeter of mercury (mmHg) | Standard Deviation 11.409 |
p-value: 0.06295% CI: [-6.743, 0.163]ANCOVA
p-value: 0.00695% CI: [-8.382, -1.469]ANCOVA
Secondary
Change From Baseline in Body Weight to Week 6
Body weight was evaluated.
Time frame: Baseline and Week 6
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Body Weight to Week 6 | Baseline (n=56,57,56) | 91.65 Kilogram (kg) | Standard Deviation 17.525 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Body Weight to Week 6 | Baseline (n=56,57,56) | 95.32 Kilogram (kg) | Standard Deviation 22.201 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Body Weight to Week 6 | Change From Baseline at Week 6 (n=54,55,56) | -0.98 Kilogram (kg) | Standard Deviation 1.964 |
| Canagliflozin 300 mg | Change From Baseline in Body Weight to Week 6 | Baseline (n=56,57,56) | 96.06 Kilogram (kg) | Standard Deviation 20.227 |
| Canagliflozin 300 mg | Change From Baseline in Body Weight to Week 6 | Change From Baseline at Week 6 (n=54,55,56) | -1.47 Kilogram (kg) | Standard Deviation 2.16 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6
The fasting plasma glucose was evaluated.
Time frame: Baseline and Week 6
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6 | Baseline (n=56,57,56) | 9.69 millimoles per liter (mmol/L) | Standard Deviation 2.085 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6 | Change From Baseline at Week 6 (n=55,54,55) | -0.03 millimoles per liter (mmol/L) | Standard Deviation 2.702 |
| Canagliflozin 300 mg | Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6 | Baseline (n=56,57,56) | 9.38 millimoles per liter (mmol/L) | Standard Deviation 2 |
| Canagliflozin 300 mg | Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6 | Change From Baseline at Week 6 (n=55,54,55) | -1.27 millimoles per liter (mmol/L) | Standard Deviation 2.164 |
Secondary
Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2 | Baseline (n=56,57,56) | 136.5 millimeter of mercury (mmHg) | Standard Deviation 11.501 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2 | Change From Baseline at Day 2 (n=50,50,50) | -1.78 millimeter of mercury (mmHg) | Standard Deviation 6.924 |
| Canagliflozin 300 mg | Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2 | Baseline (n=56,57,56) | 139.6 millimeter of mercury (mmHg) | Standard Deviation 10.925 |
| Canagliflozin 300 mg | Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2 | Change From Baseline at Day 2 (n=50,50,50) | -1.97 millimeter of mercury (mmHg) | Standard Deviation 7.343 |
Secondary
Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | 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) | -1.08 millimeter of mercury (mmHg) | Standard Deviation 4.519 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 | Baseline (n=56,57,56) | 80.53 millimeter of mercury (mmHg) | Standard Deviation 8.252 |
| Canagliflozin 100 Milligram (mg) | 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) | -2.39 millimeter of mercury (mmHg) | Standard Deviation 5.413 |
| Canagliflozin 300 mg | Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 | Baseline (n=56,57,56) | 81.81 millimeter of mercury (mmHg) | Standard Deviation 8.377 |
| Canagliflozin 300 mg | 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) | -3.23 millimeter of mercury (mmHg) | Standard Deviation 6.557 |
| Canagliflozin 300 mg | 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) | 0.03 millimeter of mercury (mmHg) | Standard Deviation 4.772 |
Secondary
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | 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) | -2.06 millimeter of mercury (mmHg) | Standard Deviation 7.309 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6 | Baseline (n=56,57,56) | 139.6 millimeter of mercury (mmHg) | Standard Deviation 11.295 |
| Canagliflozin 100 Milligram (mg) | 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) | -5.05 millimeter of mercury (mmHg) | Standard Deviation 8.656 |
| Canagliflozin 300 mg | Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6 | Baseline (n=56,57,56) | 142.8 millimeter of mercury (mmHg) | Standard Deviation 11.435 |
| Canagliflozin 300 mg | 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) | -7.36 millimeter of mercury (mmHg) | Standard Deviation 11.66 |
| Canagliflozin 300 mg | 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) | -1.16 millimeter of mercury (mmHg) | Standard Deviation 7.579 |
Secondary
Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 8.1 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | 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) | -0.23 millimeter of mercury (mmHg) | Standard Deviation 5.764 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 | Baseline (n=56,57,56) | 71.10 millimeter of mercury (mmHg) | Standard Deviation 9.091 |
| Canagliflozin 100 Milligram (mg) | 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) | -1.73 millimeter of mercury (mmHg) | Standard Deviation 6.475 |
| Canagliflozin 300 mg | Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 | Baseline (n=56,57,56) | 72.31 millimeter of mercury (mmHg) | Standard Deviation 8.515 |
| Canagliflozin 300 mg | 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) | -3.42 millimeter of mercury (mmHg) | Standard Deviation 8.056 |
| Canagliflozin 300 mg | 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) | -2.24 millimeter of mercury (mmHg) | Standard Deviation 6.037 |
Secondary
Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | 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) | -1.02 millimeter of mercury (mmHg) | Standard Deviation 8.723 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6 | Baseline (n=56,57,56) | 128.3 millimeter of mercury (mmHg) | Standard Deviation 14.527 |
| Canagliflozin 100 Milligram (mg) | 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) | -4.33 millimeter of mercury (mmHg) | Standard Deviation 11.506 |
| Canagliflozin 300 mg | Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6 | Baseline (n=56,57,56) | 130.2 millimeter of mercury (mmHg) | Standard Deviation 12.727 |
| Canagliflozin 300 mg | 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) | -6.98 millimeter of mercury (mmHg) | Standard Deviation 12.88 |
| Canagliflozin 300 mg | 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) | -4.37 millimeter of mercury (mmHg) | Standard Deviation 10.682 |
Secondary
Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
The seated heart rate was evaluated.
Time frame: Baseline, Day 2, Week 3 and 6
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | 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) | 1.07 beats per minute | Standard Deviation 8.351 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6 | Baseline (n=56,57,56) | 75.05 beats per minute | Standard Deviation 8.574 |
| Canagliflozin 100 Milligram (mg) | 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) | 1.70 beats per minute | Standard Deviation 7.305 |
| Canagliflozin 100 Milligram (mg) | 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) | 3.05 beats per minute | Standard Deviation 7.909 |
| Canagliflozin 300 mg | 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) | -1.16 beats per minute | Standard Deviation 8.083 |
| Canagliflozin 300 mg | 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) | 1.68 beats per minute | Standard Deviation 9.219 |
| Canagliflozin 300 mg | 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) | -0.89 beats per minute | Standard Deviation 8.8 |
| Canagliflozin 300 mg | Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6 | Baseline (n=56,57,56) | 78.13 beats per minute | Standard Deviation 11.06 |
Secondary
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | 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) | -7.53 millimeter of mercury (mmHg) | Standard Deviation 10.825 |
| Canagliflozin 100 Milligram (mg) | 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) | -2.22 millimeter of mercury (mmHg) | Standard Deviation 6.226 |
| Canagliflozin 100 Milligram (mg) | 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) | -4.98 millimeter of mercury (mmHg) | Standard Deviation 11.43 |
| Canagliflozin 100 Milligram (mg) | 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) | 82.37 millimeter of mercury (mmHg) | Standard Deviation 7.673 |
| Canagliflozin 100 Milligram (mg) | 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) | -0.26 millimeter of mercury (mmHg) | Standard Deviation 6.217 |
| Canagliflozin 100 Milligram (mg) | 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) | 138.5 millimeter of mercury (mmHg) | Standard Deviation 11.102 |
| Canagliflozin 100 Milligram (mg) | 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) | -2.06 millimeter of mercury (mmHg) | Standard Deviation 8.971 |
| Canagliflozin 100 Milligram (mg) | 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) | -1.52 millimeter of mercury (mmHg) | Standard Deviation 6.652 |
| Canagliflozin 300 mg | 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) | -10.6 millimeter of mercury (mmHg) | Standard Deviation 11.34 |
| Canagliflozin 300 mg | 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) | -5.11 millimeter of mercury (mmHg) | Standard Deviation 8.768 |
| Canagliflozin 300 mg | 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) | 139.2 millimeter of mercury (mmHg) | Standard Deviation 8.832 |
| Canagliflozin 300 mg | 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) | -7.38 millimeter of mercury (mmHg) | Standard Deviation 16.248 |
| Canagliflozin 300 mg | 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) | -4.23 millimeter of mercury (mmHg) | Standard Deviation 6.267 |
| Canagliflozin 300 mg | 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) | -0.87 millimeter of mercury (mmHg) | Standard Deviation 5.688 |
| Canagliflozin 300 mg | 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) | 83.02 millimeter of mercury (mmHg) | Standard Deviation 8.155 |
| Canagliflozin 300 mg | 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) | -2.43 millimeter of mercury (mmHg) | Standard Deviation 7.479 |
Secondary
Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
The standing heart rate was evaluated.
Time frame: Baseline, Day 2, Week 3 and 6
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 8.35 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | 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) | 1.44 beats per minute | Standard Deviation 9.2 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6 | Baseline (n=56,57,56) | 78.65 beats per minute | Standard Deviation 9.259 |
| Canagliflozin 100 Milligram (mg) | 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) | 3.47 beats per minute | Standard Deviation 9.383 |
| Canagliflozin 100 Milligram (mg) | 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) | 4.32 beats per minute | Standard Deviation 8.403 |
| Canagliflozin 300 mg | 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) | -0.68 beats per minute | Standard Deviation 8.547 |
| Canagliflozin 300 mg | 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) | 2.79 beats per minute | Standard Deviation 9.689 |
| Canagliflozin 300 mg | 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) | 0.48 beats per minute | Standard Deviation 9.217 |
| Canagliflozin 300 mg | Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6 | Baseline (n=56,57,56) | 81.86 beats per minute | Standard Deviation 11.949 |
Secondary
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | 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) | -7.12 millimeter of mercury (mmHg) | Standard Deviation 12.503 |
| Canagliflozin 100 Milligram (mg) | 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) | -3.47 millimeter of mercury (mmHg) | Standard Deviation 7.117 |
| Canagliflozin 100 Milligram (mg) | 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) | -7.95 millimeter of mercury (mmHg) | Standard Deviation 13.722 |
| Canagliflozin 100 Milligram (mg) | 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) | 85.25 millimeter of mercury (mmHg) | Standard Deviation 8.354 |
| Canagliflozin 100 Milligram (mg) | 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) | -0.60 millimeter of mercury (mmHg) | Standard Deviation 8.914 |
| Canagliflozin 100 Milligram (mg) | 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) | 139.3 millimeter of mercury (mmHg) | Standard Deviation 11.801 |
| Canagliflozin 100 Milligram (mg) | 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) | -2.46 millimeter of mercury (mmHg) | Standard Deviation 12.133 |
| Canagliflozin 100 Milligram (mg) | 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) | -2.51 millimeter of mercury (mmHg) | Standard Deviation 7.28 |
| Canagliflozin 300 mg | 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) | -11.9 millimeter of mercury (mmHg) | Standard Deviation 14.226 |
| Canagliflozin 300 mg | 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) | -5.91 millimeter of mercury (mmHg) | Standard Deviation 11.617 |
| Canagliflozin 300 mg | 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) | 140.8 millimeter of mercury (mmHg) | Standard Deviation 9.058 |
| Canagliflozin 300 mg | 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) | -11.3 millimeter of mercury (mmHg) | Standard Deviation 16.872 |
| Canagliflozin 300 mg | 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) | -5.36 millimeter of mercury (mmHg) | Standard Deviation 6.632 |
| Canagliflozin 300 mg | 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) | -1.32 millimeter of mercury (mmHg) | Standard Deviation 7.515 |
| Canagliflozin 300 mg | 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) | 86.09 millimeter of mercury (mmHg) | Standard Deviation 7.349 |
| Canagliflozin 300 mg | 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) | -4.55 millimeter of mercury (mmHg) | Standard Deviation 8.052 |
Secondary
Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
The difference in seated heart rate and standing heart rate was evaluated.
Time frame: Baseline, Day 2, Week 3 and 6
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | 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) | 0.37 beats per minute | Standard Deviation 7.203 |
| Canagliflozin 100 Milligram (mg) | 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) | 3.60 beats per minute | Standard Deviation 5.168 |
| Canagliflozin 100 Milligram (mg) | 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) | 1.77 beats per minute | Standard Deviation 6.538 |
| Canagliflozin 100 Milligram (mg) | 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) | 1.26 beats per minute | Standard Deviation 6.802 |
| Canagliflozin 300 mg | 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) | 0.48 beats per minute | Standard Deviation 4.472 |
| Canagliflozin 300 mg | 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) | 1.11 beats per minute | Standard Deviation 5.786 |
| Canagliflozin 300 mg | 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) | 1.38 beats per minute | Standard Deviation 5.262 |
| Canagliflozin 300 mg | 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) | 3.73 beats per minute | Standard Deviation 4.232 |
Secondary
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
The difference in seated office blood pressure and standing office blood pressure was evaluated.
Time frame: Baseline, Day 2, Week 3 and 6
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | 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) | -2.96 millimeter of mercury (mmHg) | Standard Deviation 8.397 |
| Canagliflozin 100 Milligram (mg) | 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) | 0.78 millimeter of mercury (mmHg) | Standard Deviation 8.964 |
| Canagliflozin 100 Milligram (mg) | 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) | 0.40 millimeter of mercury (mmHg) | Standard Deviation 8.562 |
| Canagliflozin 100 Milligram (mg) | 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) | -0.39 millimeter of mercury (mmHg) | Standard Deviation 11.097 |
| Canagliflozin 300 mg | 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) | -3.90 millimeter of mercury (mmHg) | Standard Deviation 11.566 |
| Canagliflozin 300 mg | 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) | -0.80 millimeter of mercury (mmHg) | Standard Deviation 9.078 |
| Canagliflozin 300 mg | 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) | -1.27 millimeter of mercury (mmHg) | Standard Deviation 9.873 |
| Canagliflozin 300 mg | 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) | 1.55 millimeter of mercury (mmHg) | Standard Deviation 8.231 |
Secondary
Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 7.33 |
| Placebo | 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 |
| Canagliflozin 100 Milligram (mg) | 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) | -0.85 millimeter of mercury (mmHg) | Standard Deviation 4.155 |
| Canagliflozin 100 Milligram (mg) | Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 | Baseline (n=56,57,56) | 78.01 millimeter of mercury (mmHg) | Standard Deviation 8.093 |
| Canagliflozin 100 Milligram (mg) | 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) | -2.18 millimeter of mercury (mmHg) | Standard Deviation 4.87 |
| Canagliflozin 300 mg | Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 | Baseline (n=56,57,56) | 79.31 millimeter of mercury (mmHg) | Standard Deviation 7.899 |
| Canagliflozin 300 mg | 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) | -3.27 millimeter of mercury (mmHg) | Standard Deviation 6.462 |
| Canagliflozin 300 mg | 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) | -0.45 millimeter of mercury (mmHg) | Standard Deviation 4.54 |