{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T16:30:15Z","timestamp":1764174615008,"version":"3.40.5"},"reference-count":38,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2019,3,6]],"date-time":"2019-03-06T00:00:00Z","timestamp":1551830400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Sanofi K.K."},{"name":"Kowa Company, Ltd."}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Diabetes Invest"],"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims\/Introduction<\/jats:title><jats:p>The present study analysis was carried out to evaluate the safety and efficacy of tofogliflozin, a sodium\u2013glucose cotransporter\u00a02 inhibitor, in Japanese patients with type\u00a02 diabetes mellitus in real\u2010world clinical practice.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>This was a 3\u2010year non\u2010interventional observational study of patients with type\u00a02 diabetes mellitus newly administered tofogliflozin who were uncontrolled on current therapy. We carried out a 12\u2010week interim analysis of tofogliflozin as part of 3\u2010year post\u2010marketing surveillance study. The incidence of adverse drug reactions was evaluated as a safety end\u2010point. As efficacy end\u2010points, glycated hemoglobin and bodyweight were evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 6,897 patients were enrolled. Tofogliflozin significantly reduced mean changes from baseline glycated hemoglobin (\u22120.63%, <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.0001) and bodyweight (\u22122.02\u00a0kg, <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.0001). The change in glycated hemoglobin and bodyweight reductions in response to tofogliflozin was consistently observed in all body mass index subgroups. Adverse drug reactions occurred in 345 of 6,712 patients (5.14%). There was a low incidence of adverse drug reactions known to be associated with sodium\u2013glucose cotransporter\u00a02 inhibitors, and they were reported as non\u2010serious. The incidences of polyuria\/pollakiuria were higher in patients aged \u226565\u00a0years than &lt;65\u00a0years, and were significantly different among estimated glomerular filtration rate subgroups. Urinary tract and genital infections occurred more frequently in women than in men.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Tofogliflozin was well tolerated, and no emerging new safety concerns were observed. Tofogliflozin significantly improved glycemic control with no impact on bodyweight gain. The short\u2010term administration of tofogliflozin is considered to have a favorable benefit\u2013risk profile in Japanese patients with type\u00a02 diabetes mellitus.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdi.13017","type":"journal-article","created":{"date-parts":[[2019,1,31]],"date-time":"2019-01-31T11:37:11Z","timestamp":1548934631000},"page":"1272-1283","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Safety and efficacy of tofogliflozin in Japanese patients with type\u00a02 diabetes mellitus in real\u2010world clinical practice: Results of 3\u2010month interim analysis of a long\u2010term post\u2010marketing surveillance study (J\u2010STEP\/LT)"],"prefix":"10.1111","volume":"10","author":[{"given":"Kazunori","family":"Utsunomiya","sequence":"first","affiliation":[{"name":"Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine The Jikei University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6673-1429","authenticated-orcid":false,"given":"Masayuki","family":"Senda","sequence":"additional","affiliation":[{"name":"Medical Affairs Sanofi K.K. 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