{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T13:38:02Z","timestamp":1761917882311,"version":"build-2065373602"},"reference-count":17,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2019,4,8]],"date-time":"2019-04-08T00:00:00Z","timestamp":1554681600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004324","name":"Astellas Pharma Inc.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004324","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate the pharmacodynamics, pharmacokinetics, and safety of the novel oral sodium\u2010glucose co\u2010transporter\u20102 inhibitor, ipragliflozin, in Japanese patients with type 1 diabetes mellitus.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>\n                      We conducted a multicentre, double\u2010blind, placebo\u2010controlled, parallel\u2010group study. Patients were randomized to receive 25, 50, or 100\u2009mg\/day ipragliflozin or placebo for 2 weeks. Key pharmacokinetic endpoints included area under the concentration\u2010time curve 24\u2009hours postdose (AUC\n                      <jats:sub>24h<\/jats:sub>\n                      ), maximum plasma concentration (C\n                      <jats:sub>max<\/jats:sub>\n                      ), and renal clearance. Key pharmacodynamic endpoints included 24\u2010hour urinary glucose excretion, mean plasma glucose AUC\n                      <jats:sub>0\u201024h<\/jats:sub>\n                      , and mean renal glucose clearance. Changes in total, basal, and bolus insulin dosages were recorded. Adverse events (AEs) were monitored for safety.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Dose\u2010dependent increases were observed in AUC\n                      <jats:sub>24h<\/jats:sub>\n                      and C\n                      <jats:sub>max<\/jats:sub>\n                      on days 1 and 14 for 25\u2010, 50\u2010, and 100\u2010mg ipragliflozin. The mean plasma glucose AUC\n                      <jats:sub>0\u201024h<\/jats:sub>\n                      was lower than that of placebo and the mean renal glucose clearance increased in a dose\u2010dependent manner from baseline, but remained unchanged in the placebo group. The mean (standard deviation) change from baseline in total daily insulin dose was greater in the ipragliflozin 25\u2010, 50\u2010, and 100\u2010mg groups (\u221214.77\u2009\u00b1\u200914.04%, \u221218.40\u2009\u00b1\u200912.49% and\u2009\u221219.25\u2009\u00b1\u200916.77%, respectively), than placebo (\u22124.51\u2009\u00b1\u200916.28%). Most AEs were mild in severity; no patients discontinued the study because of treatment\u2010emergent AEs.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The pharmacokinetic and pharmacodynamic properties of ipragliflozin in Japanese patients with type 1 diabetes mellitus were confirmed. Increases in urinary glucose excretion lead to dose\u2010dependent decreases in plasma glucose. Concomitant insulin dose decreased with ipragliflozin treatment. No clinically relevant safety concerns were identified.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.13679","type":"journal-article","created":{"date-parts":[[2019,3,1]],"date-time":"2019-03-01T03:47:44Z","timestamp":1551412064000},"page":"1445-1454","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Clinical pharmacology study of ipragliflozin in Japanese patients with type 1 diabetes mellitus: A phase 2, randomized, placebo\u2010controlled 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":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroyuki","family":"Isaka","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc., Japan\/Asia Clinical Development  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junko","family":"Toyoshima","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc., Japan\/Asia Clinical Development  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taishi","family":"Sakatani","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc., Japan\/Asia Data Science Development  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,4,8]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"Japan Diabetes Society. Treatment Guide for Diabetes 2016\u20102017.http:\/\/www.fa.kyorin.co.jp\/jds\/uploads\/Treatment_Guide_for_Diabetes_2016-2017.pdf. Accessed June 22 2018."},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199309303291401"},{"key":"e_1_2_6_4_1","unstructured":"Japan Diabetes Clinical Data Management Study Group. Basic tabulation materials (in Japanese).http:\/\/jddm.jp\/data\/index-2016.html. Accessed June 22 2018."},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-014-0204-x"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.12156"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00210-011-0713-z"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.12471"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13340-016-0283-x"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2016.1219341"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2016.1217994"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12745"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13340-014-0164-0"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-2955"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc16-1353"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12494"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2014.07.020"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/srep44128"}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fdom.13679","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dom.13679","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dom.13679","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/pdf\/10.1111\/dom.13679","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T00:57:46Z","timestamp":1761872266000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/10.1111\/dom.13679"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,4,8]]},"references-count":17,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2019,6]]}},"alternative-id":["10.1111\/dom.13679"],"URL":"https:\/\/doi.org\/10.1111\/dom.13679","archive":["Portico"],"relation":{},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"type":"print","value":"1462-8902"},{"type":"electronic","value":"1463-1326"}],"subject":[],"published":{"date-parts":[[2019,4,8]]},"assertion":[{"value":"2018-11-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-02-28","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-04-08","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}