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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 504 participants were screened. Of which, 171 participants were randomized to study treatment. 2 participants were randomized but not dosed.

Reporting Groups

	Description
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.

Participant Flow:   Overall Study

	Placebo	Canagliflozin 100 Milligram (mg)	Canagliflozin 300 mg
STARTED	56	57	56
COMPLETED	47	54	54
NOT COMPLETED	9	3	2
Adverse Event	2	0	0
Lost to Follow-up	1	1	0
Physician Decision	1	0	0
Protocol Violation	3	0	0
Withdrawal by Subject	0	1	1
Blood Pressure Withdrawal Criteria	0	1	0
Unspecified	2	0	1

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication.

Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Canagliflozin 100 Milligram (mg)	Canagliflozin 300 mg	Total
Overall Participants Analyzed  [Units: Participants]	56	57	56	169
Age  [Units: Participants] Count of Participants
<=18 years	0   0.0%	0   0.0%	0   0.0%	0   0.0%
Between 18 and 65 years	38  67.9%	46  80.7%	45  80.4%	129  76.3%
>=65 years	18  32.1%	11  19.3%	11  19.6%	40  23.7%
Age  [Units: Years] Mean (Standard Deviation)	59.6  (9.52)	57.8  (8.74)	58.3  (6.88)	58.6  (8.44)
Sex: Female, Male  [Units: Participants] Count of Participants
Female	23  41.1%	23  40.4%	25  44.6%	71  42.0%
Male	33  58.9%	34  59.6%	31  55.4%	98  58.0%

1.  Primary:

Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6   [ Time Frame: Baseline and Week 6 ]

2.  Secondary:

Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2   [ Time Frame: Baseline and Day 2 ]

3.  Secondary:

Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6   [ Time Frame: Baseline, Day 2 and Week 6 ]

4.  Secondary:

Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6   [ Time Frame: Baseline, Day 2 and Week 6 ]

5.  Secondary:

Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6   [ Time Frame: Baseline, Day 2 and Week 6 ]

6.  Secondary:

Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6   [ Time Frame: Baseline, Day 2 and Week 6 ]

7.  Secondary:

Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6   [ Time Frame: Baseline, Day 2 and Week 6 ]

8.  Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6   [ Time Frame: Baseline and Week 6 ]

9.  Secondary:

Change From Baseline in Body Weight to Week 6   [ Time Frame: Baseline and Week 6 ]

10.  Secondary:

Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]

11.  Secondary:

Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]

12.  Secondary:

Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]

13.  Secondary:

Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]

14.  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   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]

15.  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   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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