{"created":"2022-04-04T06:59:09.324075+00:00","id":2000304,"links":{},"metadata":{"_buckets":{"deposit":"d9cd7b03-3065-4f0f-95ae-14056cd94668"},"_deposit":{"id":"2000304","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"2000304"},"status":"published"},"_oai":{"id":"oai:niigata-u.repo.nii.ac.jp:02000304","sets":["453:455","471:561:562"]},"author_link":[],"control_number":"2000304","item_6_date_granted_51":{"attribute_name":"学位授与年月日","attribute_value_mlt":[{"subitem_dategranted":"2021-03-23"}]},"item_6_degree_grantor_49":{"attribute_name":"学位授与機関","attribute_value_mlt":[{"subitem_degreegrantor":[{"subitem_degreegrantor_language":"ja","subitem_degreegrantor_name":"新潟大学"},{"subitem_degreegrantor_language":"en","subitem_degreegrantor_name":"Niigata University"}],"subitem_degreegrantor_identifier":[{"subitem_degreegrantor_identifier_name":"13101","subitem_degreegrantor_identifier_scheme":"kakenhi"}]}]},"item_6_degree_name_48":{"attribute_name":"学位名","attribute_value_mlt":[{"subitem_degreename":"博士（医学）","subitem_degreename_language":"ja"}]},"item_6_description_4":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"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.","subitem_description_language":"en","subitem_description_type":"Abstract"}]},"item_6_description_5":{"attribute_name":"内容記述","attribute_value_mlt":[{"subitem_description":"Diabetes Therapy. 2021, 12(3), 655–667.","subitem_description_language":"en","subitem_description_type":"Other"}]},"item_6_description_53":{"attribute_name":"学位記番号","attribute_value_mlt":[{"subitem_description":"新大院博(医)第999号","subitem_description_language":"ja","subitem_description_type":"Other"}]},"item_6_dissertation_number_52":{"attribute_name":"学位授与番号","attribute_value_mlt":[{"subitem_dissertationnumber":"甲第4845号"}]},"item_6_relation_14":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://doi.org/10.1007/s13300-020-00991-y","subitem_relation_type_select":"DOI"}}]},"item_6_rights_15":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"【○!C】 The Author(s) 2021","subitem_rights_language":"en"},{"subitem_rights":"Creative Commons Attribution-NonCommercial 4.0 International","subitem_rights_language":"en","subitem_rights_resource":"https://creativecommons.org/licenses/by-nc/4.0/"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"open access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_abf2"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Yoshizawa, Yuta","creatorNameLang":"en"},{"creatorName":"吉澤, 優太","creatorNameLang":"ja"}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"date":[{"dateType":"Available","dateValue":"2022-04-04"}],"displaytype":"detail","filename":"r2nmk999.pdf","filesize":[{"value":"469KB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"本文","objectType":"fulltext","url":"https://niigata-u.repo.nii.ac.jp/record/2000304/files/r2nmk999.pdf"},"version_id":"48995f03-25a9-4eeb-8fcb-6829b8f75230"},{"date":[{"dateType":"Available","dateValue":"2022-04-04"}],"displaytype":"detail","filename":"r2nmk999_a.pdf","filesize":[{"value":"546KB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"要旨","objectType":"abstract","url":"https://niigata-u.repo.nii.ac.jp/record/2000304/files/r2nmk999_a.pdf"},"version_id":"7c29f820-c8a0-4335-b05e-8ace98e6864e"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"Linagliptin","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Hemodialysis","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Once-weekly dipeptidase 4 inhibitor","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Omarigliptin","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"Type 2 diabetes mellitus","subitem_subject_language":"en","subitem_subject_scheme":"Other"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"doctoral thesis","resourceuri":"http://purl.org/coar/resource_type/c_db06"}]},"item_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","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_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","subitem_title_language":"en"},{"subitem_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","subitem_title_language":"ja"}]},"item_type_id":"6","owner":"1","path":["455","562"],"pubdate":{"attribute_name":"PubDate","attribute_value":"2022-04-04"},"publish_date":"2022-04-04","publish_status":"0","recid":"2000304","relation_version_is_last":true,"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"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2022-12-15T04:30:03.711417+00:00"}