{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,6]],"date-time":"2026-09-06T17:42:32Z","timestamp":1788716552637,"version":"build-2803163510"},"reference-count":25,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2017,2,23]],"date-time":"2017-02-23T00:00:00Z","timestamp":1487808000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"AstraZeneca KK."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2017,4]]},"abstract":"\n Aims<\/jats:title>\n \n To evaluate the efficacy and safety of dapagliflozin as add\u2010on to insulin in\n J<\/jats:styled-content>\n apanese patients with type 2 diabetes.\n <\/jats:p>\n <\/jats:sec>\n \n Materials and methods<\/jats:title>\n \n Insulin\u2010treated\n J<\/jats:styled-content>\n apanese patients were randomized to 5\u2009mg dapagliflozin or placebo during a 16\u2010week double\u2010blind treatment period. Both groups then received dapagliflozin 5 or 10\u2009mg (the dose was increased at or after week 24 if glycated haemoglobin [\n HbA1c<\/jats:styled-content>\n ] at the previous visit was >7.5%) during a 36\u2010week open\u2010label extension period. The exploratory efficacy endpoint was to assess the maintenance efficacy of 5\/10\u2009mg dapagliflozin\u2009+\u2009insulin over 52\u2009weeks of treatment. Safety was assessed in terms of adverse events, laboratory variables and vital signs.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The changes in\n HbA1c<\/jats:styled-content>\n from baseline to weeks 16 and 52 were \u22120.62% and \u22120.74%, respectively, in the dapagliflozin group, vs \u22120.08% and \u22120.83%, respectively, in the placebo\u2013dapagliflozin group. Body weight decreased at both time points in the dapagliflozin group and after switching to open\u2010label dapagliflozin in the placebo\u2013dapagliflozin group. The total insulin dose decreased slightly after starting dapagliflozin. Adverse events occurred in 82.9% and 71.7% of patients in the dapagliflozin and placebo\u2013dapagliflozin groups, respectively. Hypoglycaemia occurred in 35.0% and 41.7% of patients in the dapagliflozin and placebo\u2013dapagliflozin groups, respectively, but the incidence was not increased by use of dapagliflozin in either trial period. Genital\/urinary tract infections, renal impairment\/failure, volume depletion, fracture and hepatic disorders occurred in \u22645% of patients.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n This trial showed that administration of dapagliflozin as an add\u2010on to insulin therapy was effective, was well tolerated and had insulin\u2010sparing effects in\n J<\/jats:styled-content>\n apanese patients with type 2 diabetes.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.12853","type":"journal-article","created":{"date-parts":[[2016,12,17]],"date-time":"2016-12-17T12:32:54Z","timestamp":1481977974000},"page":"562-570","source":"Crossref","is-referenced-by-count":31,"title":["Efficacy and safety of dapagliflozin over 1\u2009year as add\u2010on to insulin therapy in\n J<\/scp>\n apanese patients with type 2 diabetes: the\n DAISY<\/scp>\n (Dapagliflozin Added to patients under InSulin therapY) trial"],"prefix":"10.1111","volume":"19","author":[{"given":"Eiichi","family":"Araki","sequence":"first","affiliation":[{"name":"Department of Metabolic Medicine, Faculty of Life Sciences Kumamoto University Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukiko","family":"Onishi","sequence":"additional","affiliation":[{"name":"Division of Diabetes and Metabolism, The Institute for Adult Diseases Asahi Life Foundation Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michiko","family":"Asano","sequence":"additional","affiliation":[{"name":"Research and Development, AstraZeneca K.K. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyosung","family":"Kim","sequence":"additional","affiliation":[{"name":"Research and Development, AstraZeneca K.K. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshitaka","family":"Yajima","sequence":"additional","affiliation":[{"name":"Research and Development, AstraZeneca K.K. 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