{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T21:59:15Z","timestamp":1774303155059,"version":"3.50.1"},"reference-count":26,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2021,6,15]],"date-time":"2021-06-15T00:00:00Z","timestamp":1623715200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To assess the efficacy, safety and tolerability of ipragliflozin 50\u2009mg once daily added to sitagliptin 50\u2009mg once daily monotherapy in Japanese patients with type 2 diabetes (T2D).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>The results of two clinical trials are reported. In both trials, patients had glycated haemoglobin (HbA1c) levels of 7.0% to 10.0% on sitagliptin 50\u2009mg once daily 2\u2009weeks prior to addition of ipragliflozin or placebo. In one trial (Trial 843), patients were randomized 1:1 to addition of blinded ipragliflozin 50\u2009mg once daily (n\u00a0=\u00a073) or placebo (n\u00a0=\u00a070) for 24\u2009weeks; the primary endpoint was efficacy (change in HbA1c at Week 24). In the other trial (Trial 849), open\u2010label ipragliflozin 50\u2009mg once daily was added for 52\u2009weeks (n\u00a0=\u00a077); the primary objective was to assess safety\/tolerability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In Trial 843, baseline characteristics were similar between groups (mean age 60.5\u2009years, HbA1c 8.0%); after 24\u2009weeks, adding ipragliflozin provided significantly greater reduction in HbA1c compared to placebo: least squares mean difference \u22120.77% (95% confidence interval \u22120.98, \u22120.57;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;0.001). In Trial 843, the incidences of adverse events (AEs) overall and prespecified AEs of clinical interest (symptomatic hypoglycaemia, urinary tract infection, genital infection, hypovolaemia, and polyuria\/pollakiuria) were similar between groups. In Trial 849, specific AEs with incidence \u22655% were nasopharyngitis, pollakiuria, back pain, thirst, constipation, influenza and arthralgia; drug\u2010related AEs reported in \u22652 patients were pollakiuria, thirst and constipation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Ipragliflozin 50\u2009mg once daily added on to sitagliptin 50\u2009mg once daily monotherapy provided significant improvement in glycaemic control and was generally well tolerated in Japanese patients with T2D. ClinicalTrials.gov: NCT02577003, NCT02564211.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.14448","type":"journal-article","created":{"date-parts":[[2021,5,25]],"date-time":"2021-05-25T09:21:45Z","timestamp":1621934505000},"page":"2099-2108","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin"],"prefix":"10.1111","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1574-0565","authenticated-orcid":false,"given":"Kohei","family":"Kaku","sequence":"first","affiliation":[{"name":"Kawasaki Medical School  Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Kadowaki","sequence":"additional","affiliation":[{"name":"Department of Prevention of Diabetes and Lifestyle\u2010Related Diseases, Graduate School of Medicine The University of Tokyo  Tokyo Japan"},{"name":"Toranomon Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaka","family":"Seino","sequence":"additional","affiliation":[{"name":"Kansai Electric Power Hospital  Osaka Japan"},{"name":"Kansai Electric Power Medical Research Institute  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5494-462X","authenticated-orcid":false,"given":"Taro","family":"Okamoto","sequence":"additional","affiliation":[{"name":"Japan Development, MSD K.K  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masayoshi","family":"Shirakawa","sequence":"additional","affiliation":[{"name":"Japan Development, MSD K.K  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Asako","family":"Sato","sequence":"additional","affiliation":[{"name":"Japan Development, MSD K.K  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward A.","family":"O'Neill","sequence":"additional","affiliation":[{"name":"Merck Research Laboratories, Merck &amp; Co., Inc.  Kenilworth New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4439-6356","authenticated-orcid":false,"given":"Samuel S.","family":"Engel","sequence":"additional","affiliation":[{"name":"Merck Research Laboratories, Merck &amp; Co., Inc.  Kenilworth New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keith D.","family":"Kaufman","sequence":"additional","affiliation":[{"name":"Merck Research Laboratories, Merck &amp; Co., Inc.  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