Patients with T2DM and nocturnal hypertension
Conditions
Interventions
Empagliflozin 10mg/day is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include ARB) and diabetes.
Placebo is administrated oral
Sponsors
Jichi Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 |
|---|---|
| Nocturnal BP measured by ABPM | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Blood pressure (systolic blood pressure/diastolic blood pressure and pulse rate) -ABPM parameters (24-h BP, Daytime BP, minimum nocturnal BP, nocturnal BP variability) 2)Metabolism-related factors HbA1c, Body weight, Height, BMI, Lipids, Uric acid, HOMA-R, HOMA-beta 3)Sleep efficacy -Sleep scale (Athens insomnia scale) -Frequency of nocturnal awakening -Frequency of nocturia 4)Measures of circulating volume Plasma NT-proBNP, ANP 5)Measures of organ damage Urinary albumin/creatinine excretion ratio, Urinary Na/K, eGFR, cystatinC 6)Other measurement -The correlation between BP and blood glucose control -The correlation between BP and body weight | — |
Countries
Japan
Contacts
Public ContactThe study secretariat
Satt Co.,Ltd Clinical study promotion group
Outcome results
None listed