{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T04:54:20Z","timestamp":1769748860901,"version":"3.49.0"},"reference-count":31,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,2,20]],"date-time":"2020-02-20T00:00:00Z","timestamp":1582156800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004324","name":"Astellas Pharma US","doi-asserted-by":"publisher","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/100004324","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Diabetes Invest"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The aim of the present study was to assess the long\u2010term (52\u2010week) efficacy and safety of ipragliflozin in insulin\u2010treated Japanese patients with type\u00a01 diabetes mellitus and inadequate glycemic control.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>In this 28\u2010week, open\u2010label extension of a multicenter, randomized, placebo\u2010controlled, 24\u2010week phase\u00a0III study, ipragliflozin recipients continued treatment (50\u00a0mg, once daily), and placebo recipients were switched to once\u2010daily 50\u00a0mg ipragliflozin at the start of the extension period. The ipragliflozin dose could be increased to 100\u00a0mg if warranted. The primary end\u2010point was change in glycated hemoglobin; secondary end\u2010points were change in insulin dose and bodyweight. Safety outcomes were monitored as treatment\u2010emergent adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 53 (placebo switched to ipragliflozin) and 108 (ipragliflozin) patients completed the open\u2010label extension (treatment period\u00a02), with 24 and 44 patients, respectively, receiving dose increases. From baseline to end of treatment, the overall mean change (standard deviation [SD]) in glycated hemoglobin was \u22120.33% (0.72; \u22123.7\u00a0mmol\/mol [7.9]), with changes in basal, bolus and total insulin doses of \u22123.76\u00a0IU (SD 3.85\u00a0IU), \u22122.51\u00a0IU (SD 7.08\u00a0IU) and \u22126.27\u00a0IU (SD 8.16\u00a0IU), respectively. No serious drug\u2010related treatment\u2010emergent adverse events or deaths were reported. Treatment\u2010emergent adverse events leading to study discontinuation occurred in zero and three (2.6%) patients in the placebo switched to ipragliflozin and ipragliflozin groups, respectively; all were considered drug\u2010related. There were no cases of severe hypoglycemia or diabetic ketoacidosis, and no safety concerns related to dose increase.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The efficacy and safety of 50\u00a0mg, once\u2010daily ipragliflozin in insulin\u2010treated type\u00a01 diabetes mellitus patients were confirmed in this long\u2010term, open\u2010label extension study. No safety concerns were attributed to a dose increase to 100\u00a0mg.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdi.13181","type":"journal-article","created":{"date-parts":[[2019,11,19]],"date-time":"2019-11-19T19:14:16Z","timestamp":1574190856000},"page":"662-671","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Long\u2010term (52\u2010week) efficacy and safety of ipragliflozin add\u2010on therapy to insulin in Japanese patients with type\u00a01 diabetes mellitus: An uncontrolled, open\u2010label extension of a phase\u00a0III study"],"prefix":"10.1111","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1574-0565","authenticated-orcid":false,"given":"Kohei","family":"Kaku","sequence":"first","affiliation":[{"name":"Department of Medicine Kawasaki Medical School Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroyuki","family":"Isaka","sequence":"additional","affiliation":[{"name":"Japan\/Asia Clinical Development Astellas Pharma Inc. 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Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,2,20]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1530\/EC-17-0347"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.12810"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.metabol.2013.10.002"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.3343\/alm.2013.33.6.393"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-4695(199912)41:4<540::AID-NEU9>3.0.CO;2-P"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-1203"},{"key":"e_1_2_7_8_1","unstructured":"Japan Diabetes Clinical Data Management Study Group.Basic tabulation materials (2017).2018. 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