Who will be blinded {17a}
The 1366.0021 is a double-blind trial, with all patients, investigators, central reviewers and all other individuals involved in trial conduct or analysis remaining blinded until the database is declared ready for analysis. Randomisation codes will be provided to bioanalysts to allow for the exclusion of the placebo group from the PK analyses. The randomisation codes and results of the analyses will not be disclosed until after the database lock and will be provided to the bioanalysts prior to the trial completion of the last patient to allow the exclusion of patients receiving placebo from the PK analysis. A data monitoring committee will perform unblinded safety evaluations throughout the trial to ensure that patients are protected from potential harm. An independent statistician will prepare tables and listings from all information provided to the committee in an unblinded fashion. The 1366.0029 trial will be open-label and unblinded, with all patients receiving BI 685509 alone or in combination with empagliflozin. For both studies, an independent data monitoring committee will perform an unblinded safety evaluation at specific intervals.