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

• Material Type: 博士論文
• Title: 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
• Author/Editor: Yoshizawa, Yuta
• Author Heading: Yoshizawa, Yuta
• Publication Date: 2021-03-23
• Publication Date (W3CDTF): 2021-03-23
• Alternative Title: 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
• Degree grantor/type: 新潟大学
• Date Granted: 2021-03-23
• Date Granted (W3CDTF): 2021-03-23
• Dissertation Number: 甲第4845号
• Degree Type: 博士（医学）
• Conferring No. (Dissertation): 甲第4845号
• Text Language Code: eng
• Alias of Author: 吉澤, 優太
• Subject Heading: Linagliptin; Hemodialysis; Once-weekly dipeptidase 4 inhibitor; Omarigliptin; Type 2 diabetes mellitus
• Target Audience: 一般
• Note (General): 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.; Diabetes Therapy. 2021, 12(3), 655–667.; 新大院博(医)第999号
• Persistent ID (NDL): info:ndljp/pid/12263734; https://dl.ndl.go.jp/pid/12263734
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• Collection (particular): 国立国会図書館デジタルコレクション > デジタル化資料 > 博士論文; https://dl.ndl.go.jp/collections/A00014
• Acquisition Basis: 博士論文（自動収集）
• Date Accepted (W3CDTF): 2022-05-09T11:57:37+09:00
• Format (IMT): application/pdf
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• Periodical Title (URI): http://hdl.handle.net/10191/0002000304; https://niigata-u.repo.nii.ac.jp/records/2000304
• Data Provider (Database): 国立国会図書館 : 国立国会図書館デジタルコレクション; https://dl.ndl.go.jp