Nocturnal Hypertension, T2DM (Type 2 Diabetes Mellitus)
Conditions
Brief summary
To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension
Detailed description
The study consists of a 8-week run-in period and a 12-week treatment period.
Interventions
DRUGEmpagliflozin
Empagliflozin 10mg/day once daily before or after breakfast
DRUGPlacebo
Placebo once daily before or after breakfast
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Jichi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who meet the following criteria at the start of treatment are eligible for the study: * Receiving stable treatment with anti-hypertensive including ARB for at least 8 weeks at baseline (0W). * Receiving stable anti-diabetic treatment with/without anti-diabetics for at least 8 weeks at baseline (0W). * HbA1c\>=6.0%, \<10% * Seated office SBP 130-159mmHg or DBP 80-99mmHg * Nocturnal hypertension (SBP\>=115 mmHg) as measured by Home BP during 5days before baseline (0W). * Age\>=20
Exclusion criteria
Patients who meet any of the following criteria are not eligible for the study: * History of hypersensitivity to empagliflozin * Breast-feeding, pregnant, possibly pregnant, or plan to become pregnant * Treated with insulin or SU * With renal dysfunction (eGFR\<45mL/min/1.73m2) * With liver dysfunction (AST or ALT is 3 times higher than reference value) * Hypotension (systolic blood pressure \< 90 mmHg) * With pituitary gland dysfunction or adrenal gland dysfunction * Heart failure patients whose NYHA class is IV * Deemed ineligible for the study due to another reason by investigator * History of diabetic ketoacidosis or diabetic come within 3 months before enrollment * History of Acute myocardial infarction, unstable angina, cerebrovascular disease, or transient ischemic attack within 3 months before enrollment * Patients who have undergone percutaneous transluminal coronary angioplasty (PCI) or coronary artery bypass graftin (CABG) within 3 months before enrollment * Patients received SGLT2 inhibitor within 8 weeks before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of nocturnal blood pressure measured by ABPM | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the measures of circulating volume -ANP | 12 weeks |
| Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio | 12 weeks |
| Changes in the measures of circulating volume -Plasma NT-proBNP | 12 weeks |
| Reduction of Blood pressure measured by ABPM -24h Blood Pressure | 12 weeks |
| Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure | 12 weeks |
| Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure | 12 weeks |
| Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability | 12 weeks |
| Reduction of Metabolism-related factors -HbA1c | 12 weeks |
| Reduction of Metabolism-related factors -body weight | 12 weeks |
| Reduction of Metabolism-related factors -BMI | 12 weeks |
| Changes in the measures of organ damage -Urinary Na/K | 12 weeks |
| Reduction of Metabolism-related factors -uric acid | 12 weeks |
| Reduction of Metabolism-related factors -HOMA-R | 12 weeks |
| Reduction of Metabolism-related factors -HOMA-beta | 12 weeks |
| Change in Sleep efficacy -Sleep scale (Athens insomnia scale) | 12 weeks |
| Change in Sleep efficacy -Frequency of nocturnal awakening | 12 weeks |
| Change in Sleep efficacy -Frequency of nocturia | 12 weeks |
| Changes in the measures of organ damage -eGFR | 12 weeks |
| Changes in the measures of organ damage -cystatinC | 12 weeks |
| The correlation between blood pressure and blood glucose control | 12 weeks |
| The correlation between blood pressure and body weight | 12 weeks |
| Reduction of Metabolism-related factors -lipids | 12 weeks |
Countries
Japan
Outcome results
None listed