{"created":"2024-11-22T06:25:23.742480+00:00","id":2008026,"links":{},"metadata":{"_buckets":{"deposit":"54a6c989-b880-4d18-8c12-e89b3df69a2b"},"_deposit":{"created_by":7,"id":"2008026","owners":[7],"pid":{"revision_id":0,"type":"depid","value":"2008026"},"status":"published"},"_oai":{"id":"oai:tokushima-u.repo.nii.ac.jp:02008026","sets":["1713853213384:1713853295607"]},"author_link":["415"],"control_number":"2008026","item_10001_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2020-03-01","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"7","bibliographicPageEnd":"1175","bibliographicPageStart":"1167","bibliographicVolumeNumber":"22","bibliographic_titles":[{"bibliographic_title":"Diabetes, Obesity and Metabolism: A Journal of Pharmacology and Therapeutics","bibliographic_titleLang":"en"}]}]},"item_10001_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Aim: To compare nasal glucagon (NG) with intramuscular glucagon (IMG) for the treatment of insulin‐induced hypoglycaemia in Japanese patients with type 1 (T1DM) or type 2 diabetes mellitus (T2DM).\nMaterials and methods: This phase 3, randomized, open‐label, two‐treatment, two‐period crossover non‐inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%). After ≥8 hours of fasting, hypoglycaemia was induced with human regular insulin (intravenous infusion). Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination. The primary endpoint was the proportion of patients achieving treatment success [plasma glucose (PG) increase to ≥3.9 mmol/L (≥70 mg/dL) or ≥1.1 mmol/L (≥20 mg/dL) increase from the PG nadir within 30 minutes of receiving glucagon]. Non‐inferiority was declared if the upper limit of the two‐sided 95% confidence interval (CI) of the mean difference in the percentage of patients achieving treatment success (IMG minus NG) was <10%.\nResults: Seventy‐five patients with T1DM (n = 34) or T2DM (n = 41) were enrolled; 72 patients (50 men, 22 women) received ≥1 study drug dose (T1DM, n = 33; T2DM, n = 39). Sixty‐eight patients completed the study and were evaluable. All NG‐ and IMG‐treated patients achieved treatment success (treatment arm difference: 0%; upper limit of two‐sided 95% CI 1.47%); NG met prespecified conditions defining non‐inferiority versus IMG. Glucagon was rapidly absorbed after both nasal and intramuscular administration; PG profiles were similar between administration routes during the first 60 minutes post dose. Study drug‐related treatment‐emergent adverse events affecting >2 patients were rhinalgia, increased blood pressure, nausea, ear pain and vomiting in the NG group, and nausea and vomiting in the IMG group.\nConclusion: Nasal glucagon was non‐inferior to IMG for successful treatment of insulin‐induced hypoglycaemia in Japanese patients with T1DM/T2DM, supporting use of NG as a rescue treatment for severe hypoglycaemia.","subitem_description_language":"en","subitem_description_type":"Abstract"}]},"item_10001_publisher_8":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"John Wiley & Sons","subitem_publisher_language":"en"}]},"item_10001_rights_15":{"attribute_name":"権利情報","attribute_value_mlt":[{"subitem_rights":"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.","subitem_rights_language":"en"}]},"item_10001_source_id_9":{"attribute_name":"収録物ID","attribute_value_mlt":[{"subitem_source_identifier":"14631326","subitem_source_identifier_type":"ISSN"},{"subitem_source_identifier":"AA11435496","subitem_source_identifier_type":"NCID"}]},"item_10001_version_type_20":{"attribute_name":"出版タイプ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_1715043197608":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"open access"}]},"item_1722929371688":{"attribute_name":"出版社版DOI","attribute_value_mlt":[{"subitem_relation_name":[{"subitem_relation_name_language":"ja","subitem_relation_name_text":"10.1111/dom.14019"}],"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://doi.org/10.1111/dom.14019","subitem_relation_type_select":"DOI"}}]},"item_1723180141928":{"attribute_name":"EID","attribute_value_mlt":[{"subitem_identifier_type":"URI","subitem_identifier_uri":"366605"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorAffiliations":[{"affiliationNameIdentifiers":[{"affiliationNameIdentifier":"","affiliationNameIdentifierScheme":"ISNI","affiliationNameIdentifierURI":"http://www.isni.org/isni/"}],"affiliationNames":[{"affiliationName":"","affiliationNameLang":"ja"}]}],"creatorNames":[{"creatorName":"松久, 宗英","creatorNameLang":"ja"},{"creatorName":"マツヒサ, ムネヒデ","creatorNameLang":"ja-Kana"},{"creatorName":"Matsuhisa, Munehide","creatorNameLang":"en"}],"familyNames":[{"familyName":"松久","familyNameLang":"ja"},{"familyName":"マツヒサ","familyNameLang":"ja-Kana"},{"familyName":"Matsuhisa","familyNameLang":"en"}],"givenNames":[{"givenName":"宗英","givenNameLang":"ja"},{"givenName":"ムネヒデ","givenNameLang":"ja-Kana"},{"givenName":"Munehide","givenNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"415","nameIdentifierScheme":"WEKO"},{"nameIdentifier":"205776/profile-ja.html","nameIdentifierScheme":"徳島大学 教育研究者総覧","nameIdentifierURI":"http://pub2.db.tokushima-u.ac.jp/ERD/person/205776/profile-ja.html"},{"nameIdentifier":"60362737","nameIdentifierScheme":"e-Rad","nameIdentifierURI":"https://nrid.nii.ac.jp/ja/search/?qm=60362737"}]},{"creatorNames":[{"creatorName":"タキタ, ヤスシ","creatorNameLang":"ja"},{"creatorName":"タキタ, ヤスシ","creatorNameLang":"ja-Kana"},{"creatorName":"Takita, Yasushi","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"ナス, リサ","creatorNameLang":"ja"},{"creatorName":"ナス, リサ","creatorNameLang":"ja-Kana"},{"creatorName":"Nasu, Risa","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"ナガイ, ユキコ","creatorNameLang":"ja"},{"creatorName":"ナガイ, ユキコ","creatorNameLang":"ja-Kana"},{"creatorName":"Nagai, Yukiko","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"オオワキ, ケンジ","creatorNameLang":"ja"},{"creatorName":"オオワキ, ケンジ","creatorNameLang":"ja-Kana"},{"creatorName":"Ohwaki, Kenji","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"ナガシマ, ヒロタカ","creatorNameLang":"ja"},{"creatorName":"ナガシマ, ヒロタカ","creatorNameLang":"ja-Kana"},{"creatorName":"Nagashima, Hirotaka","creatorNameLang":"en"}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_access","date":[{"dateType":"Available","dateValue":"2020-12-17"}],"displaytype":"detail","filename":"dom_22_7_1167.pdf","filesize":[{"value":"720 KB"}],"format":"application/pdf","licensetype":"license_3","mimetype":"application/pdf","url":{"objectType":"fulltext","url":"https://tokushima-u.repo.nii.ac.jp/record/2008026/files/dom_22_7_1167.pdf"},"version_id":"194f728e-2ce5-48e6-b629-06d356693961"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"glucagon","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"hypoglycaemia","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"pharmacodynamics","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"pharmacokinetics","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"type 1 diabetes","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"type 2 diabetes","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":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"Nasal glucagon as a viable alternative for treating insulin‐induced hypoglycaemia in Japanese patients with type 1 or type 2 diabetes : A phase 3 randomized crossover study","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Nasal glucagon as a viable alternative for treating insulin‐induced hypoglycaemia in Japanese patients with type 1 or type 2 diabetes : A phase 3 randomized crossover study","subitem_title_language":"en"}]},"item_type_id":"40001","owner":"7","path":["1713853295607"],"pubdate":{"attribute_name":"PubDate","attribute_value":"2020-12-17"},"publish_date":"2020-12-17","publish_status":"0","recid":"2008026","relation_version_is_last":true,"title":["Nasal glucagon as a viable alternative for treating insulin‐induced hypoglycaemia in Japanese patients with type 1 or type 2 diabetes : A phase 3 randomized crossover study"],"weko_creator_id":"7","weko_shared_id":-1},"updated":"2025-01-29T07:18:51.132975+00:00"}