To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension
The study consists of a 8-week run-in period and a 12-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
174
Empagliflozin 10mg/day once daily before or after breakfast
Placebo once daily before or after breakfast
Fukuoka University Chikushi Hospital
Fukuoka, Japan
Kotake Hospital
Fukuoka, Japan
Onga Hospital
Fukuoka, Japan
Ishiguro Clinic
Gifu, Japan
Reduction of nocturnal blood pressure measured by ABPM
Time frame: 12 weeks
Reduction of Blood pressure measured by ABPM -24h Blood Pressure
Time frame: 12 weeks
Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure
Time frame: 12 weeks
Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure
Time frame: 12 weeks
Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability
Time frame: 12 weeks
Reduction of Metabolism-related factors -HbA1c
Time frame: 12 weeks
Reduction of Metabolism-related factors -body weight
Time frame: 12 weeks
Reduction of Metabolism-related factors -BMI
Time frame: 12 weeks
Reduction of Metabolism-related factors -lipids
Time frame: 12 weeks
Reduction of Metabolism-related factors -uric acid
Time frame: 12 weeks
Reduction of Metabolism-related factors -HOMA-R
Time frame: 12 weeks
Reduction of Metabolism-related factors -HOMA-beta
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Higashiagatsuma-machi National Health Insurance Clinic
Gunma, Japan
Katsuya Iin
Hyōgo, Japan
Minamisanriku Hospital
Miyagi, Japan
Shibuya Clinic
Saitama, Japan
International University of Health and Welfare Hospital
Tochigi, Japan
Jichi Medical University hospital
Tochigi, Japan
...and 2 more locations
Time frame: 12 weeks
Change in Sleep efficacy -Sleep scale (Athens insomnia scale)
Time frame: 12 weeks
Change in Sleep efficacy -Frequency of nocturnal awakening
Time frame: 12 weeks
Change in Sleep efficacy -Frequency of nocturia
Time frame: 12 weeks
Changes in the measures of circulating volume -Plasma NT-proBNP
Time frame: 12 weeks
Changes in the measures of circulating volume -ANP
Time frame: 12 weeks
Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio
Time frame: 12 weeks
Changes in the measures of organ damage -Urinary Na/K
Time frame: 12 weeks
Changes in the measures of organ damage -eGFR
Time frame: 12 weeks
Changes in the measures of organ damage -cystatinC
Time frame: 12 weeks
The correlation between blood pressure and blood glucose control
Time frame: 12 weeks
The correlation between blood pressure and body weight
Time frame: 12 weeks