Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese 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 Japanese 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 Japanese 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.