Effect of Empagliflozin on Endothelial Function in Cardiovascular High Risk Diabetes Mellitus: Multi-Center Placebo-Controlled Double-Blind Randomized Trial - Effect of Empagliflozin on Endothelial Function in Cardiovascular High Risk Diabetes Mellitus: Multi-Center Placebo-Controlled Double-Blind Randomized Trial (EMBLEM trial)

Department of Cardiovascular Medicine, Saga University0 sites117 target enrollmentOctober 21, 2016

Overview

Registry

who.int

Start Date

October 21, 2016

End Date

March 29, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Department of Cardiovascular Medicine, Saga University

•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