Long‐term treatment with empagliflozin as add‐on to oral antidiabetes therapy in J apanese patients with type 2 diabetes mellitus

Aims To evaluate the safety and efficacy of empagliflozin for 52 weeks as add‐on to one other oral antidiabetes therapy in J apanese patients with type 2 diabetes mellitus ( T2DM ). Methods Patients on biguanide (n = 133), thiazolidinedione (n = 273), α‐glucosidase inhibitor (n = 139), dipeptidyl‐peptidase‐4 inhibitor (n = 139) or glinide (n = 140) were randomized 1 : 1 to receive empagliflozin 10 or 25 mg double‐blind as add‐on therapy for 52 weeks. Patients on sulphonylurea ( SU ; n = 336) were randomized 2 : 2 : 1 to receive empagliflozin 10 or 25 mg double‐blind or open‐label metformin as add‐on therapy for 52 weeks. The primary objective was to evaluate safety. Change from baseline in glycated haemoglobin ( HbA1c ) at week 52 was a secondary endpoint. Results Adverse events ( AEs ) were reported in 67.6–84.6% of patients receiving empagliflozin. Confirmed hypoglycaemic AEs (plasma glucose ≤70 mg/dl and/or requiring assistance) were reported in 4.4 and 6.6%, respectively, of patients receiving empagliflozin 10 and 25 mg as add‐on to SU and in 0.0 to 2.9%, respectively, of patients receiving empagliflozin 10 and 25 mg as add‐on to other therapies. Baseline mean ± standard deviation HbA1c ranged from 7.51 ± 0.73 to 8.06 ± 0.76% across background therapy groups. At week 52, adjusted mean ± standard error changes from baseline in HbA1c ranged from −0.77 ± 0.06 to −1.00 ± 0.06% in patients receiving empagliflozin. Conclusions In J apanese patients with T2DM , empagliflozin 10 and 25 mg as add‐on to one other oral antidiabetes therapy for 52 weeks were well tolerated and were associated with clinically meaningful reductions in HbA1c .