Safety and efficacy of tofogliflozin in Japanese patients with type 2 diabetes mellitus in real‐world clinical practice: Results of 3‐month interim analysis of a long‐term post‐marketing surveillance study (J‐STEP/LT)

Abstract Aims/Introduction The present study analysis was carried out to evaluate the safety and efficacy of tofogliflozin, a sodium–glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus in real‐world clinical practice. Materials and Methods This was a 3‐year non‐interventional observational study of patients with type 2 diabetes mellitus newly administered tofogliflozin who were uncontrolled on current therapy. We carried out a 12‐week interim analysis of tofogliflozin as part of 3‐year post‐marketing surveillance study. The incidence of adverse drug reactions was evaluated as a safety end‐point. As efficacy end‐points, glycated hemoglobin and bodyweight were evaluated. Results A total of 6,897 patients were enrolled. Tofogliflozin significantly reduced mean changes from baseline glycated hemoglobin (−0.63%, P