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Methods: This prospective, randomized, open-label, parallel-group, non-inferiority/superiority, once-daily DPP4 inhibitor linagliptin-controlled, multicenter study examined glycemic control and safety of omarigliptin (UMIN000024284). Sample size was calculated to confirm non-inferiority in terms of changes in glycated hemoglobin (HbA1c). We enrolled 33 patients with T2DM on maintenance HD who had been treated with linagliptin for at least 3 months. The patients were randomized to receive omarigliptin (12.5 mg/week; n = 16) or linagliptin (5 mg/day; n = 17). Primary endpoints were changes in HbA1c and glycoalbumin (GA) over 24 weeks. 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2型糖尿病を有する維持血液透析患者の血糖コントロールにおけるオマリグリプチンの有用性の検討。24週、オープンラベル、多施設ランダム化試験
http://hdl.handle.net/10191/0002000304
http://hdl.handle.net/10191/000200030473d7d617-c059-4ab3-bdcd-e69b937689d3
名前 / ファイル | ライセンス | アクション |
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本文 (469KB)
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要旨 (546KB)
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Item type | 学位論文 / Thesis or Dissertation(1) | |||||||||
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公開日 | 2022-04-04 | |||||||||
タイトル | ||||||||||
言語 | en | |||||||||
タイトル | Effects of the Once-Weekly DPP-4 Inhibitor Omarigliptin on Glycemic Control in Patients with Type 2 Diabetes Mellitus on Maintenance Hemodialysis : A 24-Week Open-Label, Multicenter, Randomized, Controlled Study | |||||||||
タイトル | ||||||||||
言語 | ja | |||||||||
タイトル | 2型糖尿病を有する維持血液透析患者の血糖コントロールにおけるオマリグリプチンの有用性の検討。24週、オープンラベル、多施設ランダム化試験 | |||||||||
言語 | ||||||||||
言語 | eng | |||||||||
キーワード | ||||||||||
言語 | en | |||||||||
主題Scheme | Other | |||||||||
主題 | Linagliptin | |||||||||
キーワード | ||||||||||
言語 | en | |||||||||
主題Scheme | Other | |||||||||
主題 | Hemodialysis | |||||||||
キーワード | ||||||||||
言語 | en | |||||||||
主題Scheme | Other | |||||||||
主題 | Once-weekly dipeptidase 4 inhibitor | |||||||||
キーワード | ||||||||||
言語 | en | |||||||||
主題Scheme | Other | |||||||||
主題 | Omarigliptin | |||||||||
キーワード | ||||||||||
言語 | en | |||||||||
主題Scheme | Other | |||||||||
主題 | Type 2 diabetes mellitus | |||||||||
資源タイプ | ||||||||||
資源 | http://purl.org/coar/resource_type/c_db06 | |||||||||
タイプ | doctoral thesis | |||||||||
アクセス権 | ||||||||||
アクセス権 | open access | |||||||||
アクセス権URI | http://purl.org/coar/access_right/c_abf2 | |||||||||
著者 |
吉澤, 優太
× 吉澤, 優太
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抄録 | ||||||||||
内容記述タイプ | Abstract | |||||||||
内容記述 | Introduction: Dipeptidyl peptidase 4 (DPP4) inhibitors are widely used in patients with type 2 diabetes mellitus (T2DM) on maintenance hemodialysis (HD), but the efficacy of the once-weekly DPP4 inhibitor omarigliptin is not known. Methods: This prospective, randomized, open-label, parallel-group, non-inferiority/superiority, once-daily DPP4 inhibitor linagliptin-controlled, multicenter study examined glycemic control and safety of omarigliptin (UMIN000024284). Sample size was calculated to confirm non-inferiority in terms of changes in glycated hemoglobin (HbA1c). We enrolled 33 patients with T2DM on maintenance HD who had been treated with linagliptin for at least 3 months. The patients were randomized to receive omarigliptin (12.5 mg/week; n = 16) or linagliptin (5 mg/day; n = 17). Primary endpoints were changes in HbA1c and glycoalbumin (GA) over 24 weeks. Results: Differences in the mean change in primary endpoint values between the omarigliptin and linagliptin groups were − 0.60% [− 1.14, − 0.09] for HbA1c, with a two-tailed upper 95% limit (i.e., one-tailed 97.5% upper limit) of 0.25%, below the non-inferiority limit, and − 1.70% [− 4.23, + 0.88] for GA, with a two-tailed upper 95% limit of 0.75%, above the non-inferiority limit. At 24 weeks, the omarigliptin group showed significantly greater reduction in HbA1c than the linagliptin group (− 0.2% ± 0.6% vs. 0.4% ± 0.8%, two-tailed p = 0.024) and significantly greater reduction in blood glucose after a single HD session (− 18.4 ± 31.4 mg/dL vs. 25.2 ± 59.5 mg/dL, respectively, two-tailed p = 0.025). No subjects in the omarigliptin group developed hypoglycemia. Conclusions: Our data showed that omarigliptin was non-inferior to linagliptin in glycemic control. Omarigliptin is feasible for glycemic control in patients with T2DM on maintenance HD. | |||||||||
言語 | en | |||||||||
内容記述 | ||||||||||
内容記述タイプ | Other | |||||||||
内容記述 | Diabetes Therapy. 2021, 12(3), 655–667. | |||||||||
言語 | en | |||||||||
DOI | ||||||||||
識別子タイプ | DOI | |||||||||
関連識別子 | https://doi.org/10.1007/s13300-020-00991-y | |||||||||
権利 | ||||||||||
言語 | en | |||||||||
権利情報 | 【○!C】 The Author(s) 2021 | |||||||||
権利 | ||||||||||
言語 | en | |||||||||
権利情報Resource | https://creativecommons.org/licenses/by-nc/4.0/ | |||||||||
権利情報 | Creative Commons Attribution-NonCommercial 4.0 International | |||||||||
学位名 | ||||||||||
言語 | ja | |||||||||
学位名 | 博士(医学) | |||||||||
学位授与機関 | ||||||||||
学位授与機関識別子Scheme | kakenhi | |||||||||
学位授与機関識別子 | 13101 | |||||||||
言語 | ja | |||||||||
学位授与機関名 | 新潟大学 | |||||||||
言語 | en | |||||||||
学位授与機関名 | Niigata University | |||||||||
学位授与年月日 | ||||||||||
学位授与年月日 | 2021-03-23 | |||||||||
学位授与番号 | ||||||||||
学位授与番号 | 甲第4845号 | |||||||||
学位記番号 | ||||||||||
内容記述タイプ | Other | |||||||||
内容記述 | 新大院博(医)第999号 | |||||||||
言語 | ja |