Power calculation
RECRUITMENT
A sample of 60 patients was required to detect an assumed difference in LV end-diastolic volume of 15% with a significance level of 5%, and a coefficient of variation of at most 80% and a power of 80%. An interim analysis, blinded for the investigators, was performed after the recruitment of 40 patients, who had passed the visit after seven months. This revealed that further patient inclusions would not be meaningful, which was the reason for stopping further inclusions.Baseline characteristics of patients receiving empagliflozin vs. placebo are presented as mean ± standard deviation (SD) for variables with a normal distribution or median [1st and 3rd quartile (Q1, Q3)] for variables with a skewed distribution according to the Shapiro-Wilk test. Differences in baseline characteristics were assessed by the t-test or Mann-Whitney U-test, as appropriate, for continuous variables and by the χDifferences in indexes of insulin resistance/β-cell function across the three time points were investigated by repeated measures ANOVA, including an interaction term between the treatment allocation and the time of visit. The sphericity assumption of ANOVA models was checked with the Mauchly´s W test. Correction for multiple testing was performed by Bonferroni adjustment and the level of significance of the interaction p values was set at 0.01. The associations between the indexes whose change overtime resulted statistically significant and CMR parameters were investigated both at baseline and taking into consideration the change from baseline and seven months, separately in patients receiving empagliflozin vs. placebo.All statistical analyses were performed using STATA/MP 17.0.