ダウンロード数: 196
このアイテムのファイル:
ファイル | 記述 | サイズ | フォーマット | |
---|---|---|---|---|
dom.13152.pdf | 737.8 kB | Adobe PDF | 見る/開く |
タイトル: | Long-term efficacy and safety of canagliflozin in combination with insulin in Japanese patients with type 2 diabetes mellitus |
著者: | Inagaki, Nobuya Harashima, Shin-ichi Kaku, Kohei Kondo, Kazuoki Maruyama, Nobuko Otsuka, Makiko Kawaguchi, Yutaka Iijima, Hiroaki |
著者名の別形: | 稲垣, 暢也 原島, 伸一 |
キーワード: | canagliflozin hypoglycaemia insulin SGLT2 inhibitor type 2 diabetes mellitus |
発行日: | 1-Apr-2018 |
出版者: | Wiley-Blackwell |
誌名: | Diabetes, Obesity and Metabolism |
巻: | 20 |
号: | 4 |
開始ページ: | 812 |
終了ページ: | 820 |
抄録: | Aim: The aim of this study was to assess the long-term efficacy and safety of canagliflozin as add-on therapy in Japanese patients with type 2 diabetes mellitus who had inadequate glycaemic control with insulin. Materials and methods: The study comprised a 16-week, double-blind period in which patients were randomized to either placebo (P; N = 70) or canagliflozin (100 mg, CAN; N = 76), followed by a 36-week open-label period in which all patients received canagliflozin. The efficacy endpoints included the change in HbA1c from baseline to end of treatment. The safety endpoints were adverse events, hypoglycaemic events, and laboratory test values. Results: The changes from baseline (mean ± standard deviation, last observation carried forward) in the P/CAN and CAN/CAN groups, respectively, were −1.09% ± 0.85% and −0.88% ± 0.86% for HbA1c, −1.40% ± 2.54% and −2.14% ± 2.75% for body weight, and 7.84% ± 14.37% and 8.91% ± 10.80% for HOMA2-%B (all, P < .001). Adverse events occurred in 85.1% of the P/CAN group and 92.0% of the CAN/CAN group. Hypoglycaemic events occurred in 43.3% and 54.7%, respectively. All hypoglycaemic events were mild in severity and insulin dose reduction decreased the incidence rate of hypoglycaemic events. Post-hoc ordinal logistic modelling/logistic modelling showed that lower serum C-peptide at Week 0 was a risk factor for hypoglycaemia in both the P and CAN groups in the double-blind period as well as in the canagliflozin all-treatment period. Conclusions: This study demonstrates the long-term efficacy and safety of canagliflozin combined with insulin in Japanese patients. |
著作権等: | © 2017 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 not used for commercial purposes. |
URI: | http://hdl.handle.net/2433/230364 |
DOI(出版社版): | 10.1111/dom.13152 |
PubMed ID: | 29110384 |
出現コレクション: | 学術雑誌掲載論文等 |
このリポジトリに保管されているアイテムはすべて著作権により保護されています。