| 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. | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| | | Title | Denominators | Categories |
|---|
| Baseline (n=56,57,56) | | | Title | Measurements |
|---|
| - OG000136.7± 10.293
- OG001136.5± 11.501
- OG002139.6± 10.925
|
| | Change From Baseline at Week 6 (n=54,54,55) |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.062 | | Difference of Least Square Means | -3.29 | Standard Error of the Mean | 1.748 | 2-Sided | 95 | -6.743 | 0.163 | | | | | Superiority or Other | | | | | ANCOVA | | 0.006 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, Day 2 and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, Day 2 and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, Day 2 and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, Day 2 and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, Day 2 and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6 | The fasting plasma glucose was evaluated. | 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. | Posted | | Mean | Standard Deviation | millimoles per liter (mmol/L) | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| Secondary | Change From Baseline in Body Weight to Week 6 | Body weight was evaluated. | 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. | Posted | | Mean | Standard Deviation | Kilogram (kg) | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, Day 2, Week 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, Day 2, Week 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline, Day 2, Week 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline, Day 2, Week 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, Day 2, Week 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline, Day 2, Week 3 and 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks. | | OG001 | Canagliflozin 100 Milligram (mg) | Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks. | | OG002 | Canagliflozin 300 mg | Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks. |
| |