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

Diabetes, Obesity & Metabolism
E ArakiU C Broedl

Abstract

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). 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. 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 g...Continue Reading

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Citations

Sep 7, 2016·Expert Opinion on Pharmacotherapy·Hiroyuki ItoMariko Abe
Sep 23, 2016·Expert Opinion on Drug Safety·Puneet Gupta, William B White
Sep 15, 2016·Journal of Diabetes·Wenying YangC David Sjöström
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Apr 12, 2019·Diabetes, Obesity & Metabolism·Ilaria DicembriniMatteo Monami
Oct 17, 2019·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Yuichiro ItoTomomi Kimura
Oct 20, 2019·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Yuichiro ItoTomomi Kimura
Aug 11, 2020·Current Medical Research and Opinion·Chutintorn SriphrapradangThep Himathongkam

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