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

Phase 4CompletedNCT01939496

Janssen Scientific Affairs, LLC171 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

171

Conditions

Diabetes Mellitus, Type 2

Interventions

CanagliflozinDRUG

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.

PlaceboDRUG

One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (57)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Gulf Shores, Alabama, United States

Unnamed facility

Avondale, Arizona, United States

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Glendale, California, United States

Unnamed facility

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

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

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

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

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

Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6

The fasting plasma glucose was evaluated.

Time frame: Baseline and Week 6

Change From Baseline in Body Weight to Week 6

Body weight was evaluated.

Time frame: Baseline and Week 6

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.