Study design and patients
TYPE 2 DIABETES
The rationale and design of the PROTECT study (University Hospital Medical Information Network Center: ID000018440) have already been explained [Between September 2015 and June 2018, 488 patients with type 2 diabetes were enrolled, and 482 patients were randomized to receive either standard antihyperglycemic treatment (control group, n = 241) or add-on ipragliflozin treatment (ipragliflozin group, n = 241) at a 1:1 ratio (Fig. 
Flow diagram of participants in the PROTECT studyIn the PROTECT study, the primary endpoint in the main analysis was the change in the mean common carotid artery IMT from baseline to 24 months after the start of treatment; the results have already been reported [Of the 488 patients, serial FMD measurements were performed in 32 patients in the control group and 26 patients in the ipragliflozin group before and after 24 months of treatment (Fig. 