original article

Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus E. Araki1 , Y. Tanizawa2 , Y. Tanaka3 , A. Taniguchi3 , K. Koiwai3 , G. Kim4 , A. Salsali5 , H. J. Woerle4 & U. C. Broedl4 1 Department of Metabolic Medicine, Kumamoto University, Kumamoto, Japan 2 Division of Endocrinology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan 3 Nippon Boehringer Ingelheim Co., Ltd, Tokyo, Japan 4 Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany 5 Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA

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. Keywords: empagliflozin, SGLT2 inhibitor, type 2 diabetes Date submitted 7 November 2014; date of first decision 26 November 2014; date of final acceptance 10 March 2015

Introduction The Japan Ministry of Health, Labour and Welfare has identified type 2 diabetes mellitus (T2DM) as a healthcare priority [1]. It is estimated that 6.7 million people in Japan will have diabetes by 2035 [2], the vast majority of whom will have T2DM. The Japan Diabetes Society recommends monotherapy with an oral antidiabetes agent, insulin or a glucagon-like peptide-1 agonist as first-line pharmacotherapy for T2DM [3]. If monotherapy fails, combination therapy should be initiated [3]. Use of monotherapy markedly decreased and use of combination therapy increased in Japan between 2002 and 2011, yet over 50% of patients with T2DM were not achieving the glycaemic target of glycated haemoglobin (HbA1c) 13.3 mmol/l (>240 mg/dl) after an overnight fast, confirmed by a second measurement]; estimated glomerular filtration rate (eGFR; according to the Modification of Diet in Renal Disease formula) during screening or run-in of

Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus.

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 di...
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