{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T08:56:22Z","timestamp":1780044982662,"version":"3.53.1"},"reference-count":22,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2019,7,11]],"date-time":"2019-07-11T00:00:00Z","timestamp":1562803200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004948","name":"Astellas Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004948","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To assess the efficacy and safety of once\u2010daily ipragliflozin 50\u2009mg versus placebo in Japanese people with type 1 diabetes mellitus (T1DM) inadequately controlled with insulin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>We conducted a multicentre, double\u2010blind, parallel\u2010group, placebo\u2010controlled phase 3 study. Participants (N = 175) were randomized (2:1) to receive once\u2010daily ipragliflozin 50\u2009mg (n = 115) or placebo (n = 60), combined with insulin, for 24\u2009weeks. The primary endpoint was change in glycated haemoglobin (HbA1c); key secondary endpoints included change in insulin dose and body weight. Treatment\u2010emergent adverse events (TEAEs) were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The ipragliflozin group demonstrated a significant decrease in HbA1c from baseline to end of treatment versus the placebo group: adjusted mean difference (AMD) \u22123.8\u2009mmol\/mol (95% confidence interval [CI] \u22126.2, \u22121.5) or\u2009\u2212\u20090.36% (95% CI \u22120.57, \u22120.14;\n                      <jats:italic>P<\/jats:italic>\n                      = 0.001). Significant reductions in total daily insulin dose (AMD \u22127.35\u2009IU [95% CI \u22129.09, \u22125.61];\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001) and body weight (AMD \u22122.87\u2009kg [95% CI \u22123.58, \u22122.16];\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001) were observed for the ipragliflozin group versus placebo. Two serious TEAEs occurred (major hypoglycaemia and abdominal abscess); both were in the placebo group. All other TEAEs were mild or moderate in severity. Four cases of study discontinuation occurred; three in the placebo group and one in the ipragliflozin group. No diabetic ketoacidosis was reported for any participant in this study.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Daily ipragliflozin 50\u2009mg in combination with insulin significantly reduced HbA1c, daily insulin dose and body weight versus placebo in people with T1DM. No safety concerns were identified after 24\u2009weeks of treatment. Overall, once\u2010daily ipragliflozin 50\u2009mg was both efficacious and well tolerated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.13807","type":"journal-article","created":{"date-parts":[[2019,6,7]],"date-time":"2019-06-07T08:19:34Z","timestamp":1559895574000},"page":"2284-2293","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":48,"title":["Efficacy and safety of ipragliflozin add\u2010on therapy to insulin in Japanese patients with type 1 diabetes mellitus: A randomized, double\u2010blind, phase 3 trial"],"prefix":"10.1111","volume":"21","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":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Isaka","sequence":"additional","affiliation":[{"name":"Japan\/Asia Clinical Development Astellas Pharma Inc.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taishi","family":"Sakatani","sequence":"additional","affiliation":[{"name":"Data Science, Astellas Pharma Inc.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junko","family":"Toyoshima","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Exploratory Development, Astellas Pharma Inc.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,7,11]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1530\/EC-17-0347"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.12810"},{"key":"e_1_2_8_4_1","unstructured":"Japan Diabetes Clinical Data Management Study Group Basic tabulation materials.2018;http:\/\/jddm.jp\/data\/index-2017.html. 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