Patient enrolment and randomization
type 2 diabetes mellitus, left ventricular diastolic dysfunction
TYPE 2 DIABETES MELLITUS, LEFT VENTRICULAR DIASTOLIC DYSFUNCTION
The main inclusion criteria of the EmDia trial were: (i) age from 18 to 84 years, (ii) diagnosis of type 2 diabetes mellitus with stable glucose-lowering background therapy and/or dietary treatment for at least 12 weeks, (iii) HbA1c ≥ 6.5% and ≤ 10.0% in subjects on antidiabetic background therapy or HbA1c ≥ 6.5% and ≤ 9.0% for drug-naïve subjects with dietary treatment, and (iv) prevalent left ventricular diastolic dysfunction defined as left ventricular lateral Patients who met all inclusion criteria and none of the exclusion criteria were randomized 1:1 to the intervention or control group at the baseline visit. Block-randomization including sex-stratification was performed by an independent institution (Interdisciplinary Center for Clinical Trials (IZKS), Mainz, Germany). During the 12-week trial period after randomization, patients received empagliflozin at a dose of 10 mg per day or an identical placebo in addition to the concomitant medication.