{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T12:25:36Z","timestamp":1774009536780,"version":"3.50.1"},"reference-count":41,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,12,26]],"date-time":"2019-12-26T00:00:00Z","timestamp":1577318400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","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":[[2020,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To investigate the safety and tolerability of 5 and 10\u2009mg dapagliflozin added to insulin therapy over 52\u2009weeks in Japanese patients with inadequately controlled type 1 diabetes mellitus (T1DM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>\n                      This randomized, open\u2010label, parallel\u2010group, multicentre phase III clinical trial was conducted from October 26, 2015 to June 15, 2017. The primary endpoint was the occurrence of adverse events such as hypoglycaemia and diabetic ketoacidosis. Secondary endpoints included changes in glycaemic parameters, total daily insulin dosage and body weight over time. The efficacy of dapagliflozin in patients stratified by body mass index (BMI) &lt;25.0 and\u2009\u226525.0\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      was evaluated in a subgroup analysis.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 151 patients received 5\u2009mg (n = 76) or 10\u2009mg (n = 75) dapagliflozin once daily for 52\u2009weeks. Adverse events were observed in 88.2% and 73.3% of patients in the 5 and 10\u2009mg dapagliflozin groups, respectively. Severe hypoglycaemia was reported in 2.6% (n = 2) and 6.7% (n = 5) of patients, and diabetic ketoacidosis in 2.6% (n = 2) and 1.3% (n = 1) of patients in the 5 and 10\u2009mg dapagliflozin groups, respectively. The adjusted mean (95% confidence interval) changes in glycated haemoglobin at week 52 were\u2009\u22120.33% (\u22120.50, \u22120.15) and\u2009\u22120.36% (\u22120.53, \u22120.18) in the 5 and 10\u2009mg dapagliflozin groups, respectively. There were no differences in efficacy parameters when stratified by BMI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study demonstrated the long\u2010term safety and tolerability of dapagliflozin added to insulin therapy in Japanese patients with inadequately controlled T1DM.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.13922","type":"journal-article","created":{"date-parts":[[2019,11,19]],"date-time":"2019-11-19T13:44:53Z","timestamp":1574171093000},"page":"540-548","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT\u20105): 52\u2010week results from a randomized, open\u2010label, phase III clinical trial"],"prefix":"10.1111","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4064-7525","authenticated-orcid":false,"given":"Eiichi","family":"Araki","sequence":"first","affiliation":[{"name":"Department of Metabolic Medicine, Faculty of Life Sciences Kumamoto University  Kumamoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5961-1816","authenticated-orcid":false,"given":"Hirotaka","family":"Watada","sequence":"additional","affiliation":[{"name":"Department of Metabolism and Endocrinology Juntendo University Graduate School of Medicine  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuko","family":"Uchigata","sequence":"additional","affiliation":[{"name":"Diabetes Center, Tokyo Women's Medical University School of Medicine  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Osamu","family":"Tomonaga","sequence":"additional","affiliation":[{"name":"Diabetes and Lifestyle Center, Tomonaga Clinic  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hitomi","family":"Fujii","sequence":"additional","affiliation":[{"name":"Internal Medicine, Tama\u2010center Mirai Clinic  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Ohashi","sequence":"additional","affiliation":[{"name":"Internal Medicine, Oyama East Clinic  Tochigi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tadashi","family":"Okabe","sequence":"additional","affiliation":[{"name":"Okabe Clinic  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michiko","family":"Asano","sequence":"additional","affiliation":[{"name":"Research &amp; Development, AstraZeneca K.K.  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fredrik","family":"Thoren","sequence":"additional","affiliation":[{"name":"Global Medicine Development, AstraZeneca Gothenburg  M\u00f6lndal Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hyosung","family":"Kim","sequence":"additional","affiliation":[{"name":"Research &amp; Development, AstraZeneca K.K.  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshitaka","family":"Yajima","sequence":"additional","affiliation":[{"name":"Research &amp; Development, AstraZeneca K.K.  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna Maria","family":"Langkilde","sequence":"additional","affiliation":[{"name":"Global Medicine Development, AstraZeneca Gothenburg  M\u00f6lndal Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,12,26]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-1140"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.2010.02956.x"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.5604\/12321966.1141381"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)60484-9"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1008862"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0113635"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2013-1589"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.metabol.2015.09.002"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.5.1374"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.2006.01847.x"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-013-2904-2"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2012.07.036"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-007-0820-z"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2009-0473"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.4158\/EP.14.6.782"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1155\/2016\/5347262"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-1241.2012.02911.x"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2012.01659.x"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc10-0612"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc08-1863"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12047"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12325"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13593"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc13-2955"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-018-4671-6"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13659"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13696"},{"key":"e_1_2_8_29_1","first-page":"864","article-title":"Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT\u20101): 24 week results from a multicentre, double\u2010blind, phase 3, randomised controlled trial","volume":"5","author":"Dandona P","year":"2017","journal-title":"Lancet"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-0623"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-1087"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.28.5.1245"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc09-9032"},{"key":"e_1_2_8_34_1","first-page":"451","article-title":"Sodium\u2010glucose linked transporter 2 (SGLT2) inhibitors in the management of type\u20102 diabetes: a drug class overview","volume":"40","author":"Mosley JF","year":"2015","journal-title":"P T"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1080\/00325481.2016.1153941"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdiacomp.2013.05.004"},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdiacomp.2013.04.012"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1812389"},{"key":"e_1_2_8_39_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.metabol.2015.12.007"},{"key":"e_1_2_8_40_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12882"},{"key":"e_1_2_8_41_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc17-1721"},{"key":"e_1_2_8_42_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-2316"}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dom.13922","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dom.13922","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/pdf\/10.1111\/dom.13922","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T06:39:49Z","timestamp":1761892789000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/10.1111\/dom.13922"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,12,26]]},"references-count":41,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2020,4]]}},"alternative-id":["10.1111\/dom.13922"],"URL":"https:\/\/doi.org\/10.1111\/dom.13922","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.1111\/DOM.13922\/v1\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13922\/v2\/response1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13922\/v1\/review3","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13922\/v2\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13922\/v1\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13922\/v1\/review2","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.13922\/v2\/decision1","asserted-by":"object"}]},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"value":"1462-8902","type":"print"},{"value":"1463-1326","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,12,26]]},"assertion":[{"value":"2019-08-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-14","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-12-26","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}