Type 2 diabetes with high risk of cardiovascular disease
Conditions
Interventions
Empagliflozin 10 mg/day is administered orally before or after breakfast for 24 weeks while continuing the existing treatment for diabetes and other complicating diseases. During the treatment period,
Sponsors
Department of Cardiovascular Medicine, Saga University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age >=20 at consent 2) Type 2 diabetic patients with HbA1c (NGSP) >=6.0% and <10.0%, not changed the dosage of antidiabetic agents within a month before consent and considered possible to start or add/switch the study drug by investigator 3) Patients who received an explanation of the study and provided a written informed consent Patients who meet at least one condition of the list 4) - 8) below 4) Chronic heart failure (NYHA class I-III, systolic or diastolic failure) NYHA class remains unchanged in a month before consent, and the dose of heart failure drug (ACE inhibitor, ARB, beta blocker, diuretic etc.) also remains unchanged in a month before consent. 5) History of coronary artery disease (myocardial infarction and angina etc.) or cerebral infarction 6) Previous coronary revascularization (percutaneous transluminal coronary angioplasty, irrespective of the use of stent, or coronary artery bypass grafting 7) Presence of coronary artery stenosis >=50% luminal narrowing depicted by angiography or multi-slice computed tomography 8) Diagnosis of arteriosclerosis obliterans according to Guidelines for management of peripheral arterial occlusive diseases (JCS 2015 revised)
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes 2) History of diabetic ketoacidosis or diabetic coma within 6 months 3) With severe renal dysfunction (eGFR < 45 mL/min/1.73 m2 or undergoing dialysis) 4) With serious liver dysfunction (AST or ALT is 3 times higher than site reference value) 5) Heart failure patients whose NYHA class is IV 6) With pituitary gland dysfunction or adrenal gland dysfunction 7) Hypotension (systolic blood pressure < 90 mmHg) 8) History of ischemic heart disease, myocardial infarction, unstable angina, cerebrovascular disease, or transient ischemic attack within 3 months before consent 9) Patients who have undergone percutaneous transluminal coronary angioplasty or coronary artery bypass grafting within 3 months before consent 10) Patients received SGLT2 inhibitor within a month before consent 11) Pregnant, possibly pregnant, planning to be pregnant, or nursing women 12) History of hypersensitivity to empagliflozin 13) Considered not eligible for the study by investigator due to complicating malignancy or careful administration of empagliflozin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in RHI from baseline to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change and correlation with RHI change from baseline to 24 weeks in following items: 1) Double product (systolic blood pressure x heart rate) 2) baPWV (both sides) 3) Coefficient of variation of the R-R intervals in the ECG at rest and deep breathing (including the differences between the results at rest and deep breathing) and standard deviation of heartbeat intervals 4) LVEF, E/e' (echocardiogram) 5) Blood biomarkers NT-proBNP, interleukin-8, high-sensitivity troponin I, receptor for advanced glycation end products (RAGE), angiopoietin-like protein 2 (ANGPTL2) 6) Renal function Serum creatinine, eGFR, albumin excretion in urine corrected by creatinine, L-FABP in urine corrected by creatinine 7) Glycemic control HbA1c, fasting blood glucose, glycoalbumin 8) Other laboratory tests Blood pressure, pulse pressure, heart rate, body weight, BMI, total cholesterol, HDL-C, LDL-C, triglyceride, non-HDL-C, AST, ALT, gamma-GTP, uric acid, RBC, hemoglobin, hematocrit 9) Parameters measured by RH-PAT test other than RHI (eg. AI, HRV) | — |
Countries
Japan
Contacts
Public ContactKoichi Node
Saga University Department of Cardiovascular Medicine
Outcome results
None listed