Phase 4
Completed N=169
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
Source: ClinicalTrials.gov NCT01939496 ↗Enrolled (actual)
169
Serious AEs
0.6%
Results posted
Apr 2016
Primary outcomePrimary: Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6 — 136.7; 136.5; 139.6; -1.26 millimeter of mercury (mmHg) — p=0.062
◆ Published Evidence
Highly cited
140citations · ~16 / year
Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis.
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.
Linked Publications
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Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6 |
136.7; 136.5; 139.6; -1.26; -4.78; -7.31 | 0.062 |
| SECONDARY Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2 |
136.7; 136.5; 139.6; 0.49; -1.78; -1.97 | — |
| SECONDARY Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 |
78.36; 78.01; 79.31; 1.01; -0.85; -0.45 | — |
| SECONDARY Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6 |
139.4; 139.6; 142.8; 0.96; -2.06; -1.16 | — |
| SECONDARY Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 |
80.84; 80.53; 81.81; 1.21; -1.08; 0.03 | — |
| SECONDARY Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6 |
129.3; 128.3; 130.2; -0.19; -1.02; -4.37 | — |
| SECONDARY Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6 |
71.57; 71.10; 72.31; 0.87; -0.23; -2.24 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6 |
9.84; 9.69; 9.38; -0.38; -0.03; -1.27 | — |
| SECONDARY Change From Baseline in Body Weight to Week 6 |
91.65; 95.32; 96.06; 0.14; -0.98; -1.47 | — |
| SECONDARY Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6 |
137.7; 138.5; 139.2; -3.24; -2.06; -5.11 | — |
| SECONDARY Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6 |
140.3; 139.3; 140.8; -4.36; -2.46; -5.91 | — |
| SECONDARY Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6 |
79.57; 75.05; 78.13; -1.40; 3.05; 1.68 | — |
| SECONDARY Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6 |
82.54; 78.65; 81.86; 0.27; 4.32; 2.79 | — |
| 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 |
2.65; 0.78; 1.55; -1.13; -0.39; -0.80 | — |
| 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 |
2.96; 3.60; 3.73; 1.67; 1.26; 1.11 | — |
Eligibility Criteria
Inclusion Criteria
- patients with a diagnosis of type 2 diabetes mellitus
- patients with hypertension (seated office SBP of >=130 mmHg and = 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.
Data sourced from ClinicalTrials.gov (NCT01939496) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.