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タイトル: | Efficacy and safety of canagliflozin as add-on therapy to a glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week, open-label, phase IV study |
著者: | Harashima, Shin ichi Inagaki, Nobuya Kondo, Kazuoki Maruyama, Nobuko Otsuka, Makiko Kawaguchi, Yutaka Watanabe, Yumi |
著者名の別形: | 原島, 伸一 稲垣, 暢也 |
キーワード: | Canagliflozin GLP-1 receptor agonist Phase IV SGLT2 inhibitor Type 2 diabetes |
発行日: | Jul-2018 |
出版者: | Blackwell Publishing Ltd |
誌名: | Diabetes, Obesity and Metabolism |
巻: | 20 |
号: | 7 |
開始ページ: | 1770 |
終了ページ: | 1775 |
抄録: | Sodium‐glucose co‐transporter‐2 (SGLT2) inhibitors and glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) are antihyperglycaemic agents with weight‐lowering effects. The efficacy and safety of the SGLT2 inhibitor canagliflozin as add‐on therapy in Japanese patients with type 2 diabetes mellitus (T2DM) and inadequate glycaemic control with a GLP‐1RA (≥12 weeks) were evaluated in this phase IV study. Patients received canagliflozin 100 mg once daily for 52 weeks. Efficacy endpoints included change in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP) and HDL cholesterol from baseline to week 52. Safety endpoints included adverse events (AEs), hypoglycaemia and laboratory tests. Of the 71 patients treated with canagliflozin, 63 completed the study. At 52 weeks, HbA1c was significantly reduced from baseline (−0.70%; paired t test, P < .001). Significant changes were also observed in FPG (−34.7 mg/dL), body weight (−4.46%), SBP (−7.90 mm Hg), and HDL cholesterol (7.60%; all P < .001). The incidence of AEs, adverse drug reactions and hypoglycaemia was 71.8%, 32.4% and 9.9%, respectively. All hypoglycaemic events were mild. These findings suggest that the long‐term combination of canagliflozin with a GLP‐1RA is effective and well tolerated in Japanese patients with T2DM. |
著作権等: | © 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
URI: | http://hdl.handle.net/2433/232840 |
DOI(出版社版): | 10.1111/dom.13267 |
PubMed ID: | 29473709 |
出現コレクション: | 学術雑誌掲載論文等 |
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