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

Hypertension Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Blood Pressure Reduction With Ambulatory Blood Pressure Monitoring (ABPM), Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Hypertension and Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939496
• Other study ID #: CR102208
• Secondary ID: 28431754DIA4002
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2013
• Last updated: March 2, 2017
• Start date: October 2013
• Est. completion date: April 2015

Study information

• Verified date: March 2017
• Source: Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Scientific Affairs, LLC

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and Week 6
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.	Baseline and Day 2
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.	Baseline, Day 2 and Week 6
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.	Baseline, Day 2 and Week 6
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.	Baseline, Day 2 and Week 6
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.	Baseline, Day 2 and Week 6
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.	Baseline, Day 2 and Week 6
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6	The fasting plasma glucose was evaluated.	Baseline and Week 6
Secondary	Change From Baseline in Body Weight to Week 6	Body weight was evaluated.	Baseline and Week 6
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.	Baseline, Day 2, Week 3 and 6
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.	Baseline, Day 2, Week 3 and 6
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.	Baseline, Day 2, Week 3 and 6
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.	Baseline, Day 2, Week 3 and 6
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.	Baseline, Day 2, Week 3 and 6
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.	Baseline, Day 2, Week 3 and 6