{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T04:24:28Z","timestamp":1773030268160,"version":"3.50.1"},"reference-count":12,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2016,6,29]],"date-time":"2016-06-29T00:00:00Z","timestamp":1467158400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100008373","name":"Takeda Pharmaceutical Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008373","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002973","name":"Daiichi-Sankyo","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002973","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002975","name":"Dainippon Sumitomo Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002975","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004634","name":"Mount Sylvia Diatomite","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004634","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004191","name":"Novo Nordisk","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004191","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007723","name":"Takeda Pharmaceuticals U.S.A.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007723","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:p>This multicentre, open\u2010label, phase III study investigated the safety and efficacy of the G\u2010protein\u2010coupled receptor 40 agonist fasiglifam. Japanese patients with type 2 diabetes and inadequate glycaemic control despite diet and\/or exercise (n = 282), or despite diet and\/or exercise plus one oral antidiabetic agent [sulphonylurea (n = 262), rapid\u2010acting insulin secretagogue (n = 124), \u03b1\u2010glucosidase inhibitor (n = 141), biguanide (n = 136), thiazolidinedione (n = 139) or dipeptidyl peptidase\u20104 inhibitor (n = 138)] were randomized to treatment with fasiglifam 25 or 50 mg once daily for 52 weeks. The primary endpoints were safety variables. The overall incidence of treatment\u2010emergent adverse events (TEAEs) was 75.4\u201385.1% in the 25 mg group and 78.9\u201389.9% in the 50 mg group; most TEAEs were mild. Hypoglycaemia was negligible with fasiglifam monotherapy and most common with sulphonylurea combination therapy (12.4 and 9.1% for 25 and 50 mg groups, respectively). Abnormal liver\u2010related laboratory values were uncommon. Glycated haemoglobin levels decreased from week 2 in all groups and were maintained to week 52. Although fasiglifam as monotherapy or in combination regimens was well tolerated during long\u2010term treatment, global concerns about liver safety led to termination of its development after study completion.<\/jats:p>","DOI":"10.1111\/dom.12693","type":"journal-article","created":{"date-parts":[[2016,5,14]],"date-time":"2016-05-14T00:53:04Z","timestamp":1463187184000},"page":"925-929","source":"Crossref","is-referenced-by-count":58,"title":["Long\u2010term safety and efficacy of fasiglifam (TAK\u2010875), a G\u2010protein\u2010coupled receptor 40 agonist, as monotherapy and combination therapy in Japanese patients with type 2 diabetes: a 52\u2010week open\u2010label phase III study"],"prefix":"10.1111","volume":"18","author":[{"given":"K.","family":"Kaku","sequence":"first","affiliation":[{"name":"Department of Medicine Kawasaki Medical School  Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K.","family":"Enya","sequence":"additional","affiliation":[{"name":"Japan Development Center Takeda Pharmaceutical Co. 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PFSB\/ELD Notification No. 0709\u20101 9 July2010."},{"key":"e_1_2_7_12_1","unstructured":"Evaluation and Licensing Division Pharmaceutical and Food Safety Bureau Ministry of Health Labour and Welfare.Questions and answers (Q&As) regarding the guideline for clinical evaluation of oral hypoglycemic agents. Administrative notice 9 July2010."},{"key":"e_1_2_7_13_1","unstructured":"Takeda Press Release.Takeda announces termination of fasiglifam (TAK\u2010875) development. 26 December2013. Available from URL:http:\/\/www.takeda.us\/newsroom\/press_release_detail.aspx?year=2013&id=296. Accessed 15 March 2016."}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fdom.12693","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/pdf\/10.1111\/dom.12693","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T04:32:35Z","timestamp":1761885155000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/10.1111\/dom.12693"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,6,29]]},"references-count":12,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2016,9]]}},"alternative-id":["10.1111\/dom.12693"],"URL":"https:\/\/doi.org\/10.1111\/dom.12693","archive":["Portico"],"relation":{},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"value":"1462-8902","type":"print"},{"value":"1463-1326","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,6,29]]}}}