Allocation and patient characteristics
In the main UTOPIA study, 340 participants were randomly allocated to either the tofogliflozin group (n = 169) or the conventional treatment group (n = 171) between January 2016 and November 2016. Of these, 304 completed the follow-up. After the completion of the follow-up in the main UTOPIA study, between June 2018 and April 2019, each participant was asked to participate in this UTOPIA Extension study. Since 13 participants were excluded (6 participants did not give consent to participate in this UTOPIA Extension study, and 7 participants discontinued the hospital visits), 291 participants were enrolled in this UTOPIA Extension study. Of these, 146 and 145 were assigned to the tofogliflozin and conventional treatment groups, respectively, in the UTOPIA Extension study (Fig. Study flow chart showing patient enrollment and analysisClinical characteristics of patients at week 0 (baseline) of the main UTOPIA studyData are presented as number (%) of patients or mean ± standard deviation