{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,18]],"date-time":"2026-01-18T00:53:44Z","timestamp":1768697624956,"version":"3.49.0"},"reference-count":29,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2018,8,2]],"date-time":"2018-08-02T00:00:00Z","timestamp":1533168000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Merck Serono China Co. Ltd., an affiliate of Merck KGaA, Darmstadt, Germany"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2018,12]]},"abstract":"\n Aim<\/jats:title>\n To confirm non\u2010inferiority of biphasic insulin aspart 30 (BIAsp 30) plus metformin to BIAsp 30 in lowering glycated haemoglobin (HbA1c) in Chinese patients with inadequately controlled type 2 diabetes using oral antidiabetic drugs.<\/jats:p>\n <\/jats:sec>\n \n Materials and methods<\/jats:title>\n \n In this 16\u2010week, prospective, randomized, open\u2010label, multicentre, parallel\u2010controlled study, patients aged 18\u201079\u2009years with HbA1c\u2009\u22657% were randomized to BIAsp 30 plus metformin (\n n<\/jats:italic>\n \u2009=\u2009130) or BIAsp 30 (\n n<\/jats:italic>\n \u2009=\u2009127). Initially, 500\u2009mg metformin was administered twice daily and BIAsp 30 was administered at 0.2\u20100.3 U\/kg\/d. Changes in HbA1c % from baseline to week 16 as well as secondary and safety endpoints were assessed.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n In total, 83.66% of patients in the BIAsp 30 plus metformin (\n n<\/jats:italic>\n \u2009=\u2009110) and the BIAsp 30 (\n n<\/jats:italic>\n \u2009=\u2009105) groups completed the study. Mean (\u00b1standard deviation) change in HbA1c from baseline to endpoint was \u22121.74\u2009\u00b1\u20091.64% and\u2009\u22121.32\u2009\u00b1\u20092.05% with BIAsp 30 plus metformin and BIAsp 30, respectively. Least squares mean treatment difference was \u22120.67% (95% CI, \u22121.06; \u22120.28). The upper limit of the 95% CI was <0.4 (non\u2010inferiority margin). A significantly higher proportion of individuals reached HbA1c <7% with BIAsp 30 plus metformin than with BIAsp 30 (53.15% vs 35.19%;\n P<\/jats:italic>\n \u2009=\u20090.0074). At endpoint, daily BIAsp 30 dose (\n P<\/jats:italic>\n \u2009<\u20090.001) and weight gain were significantly lower (\n P<\/jats:italic>\n \u2009<\u20090.05) in the BIAsp 30 plus metformin group compared with the BIAsp 30 group. No between\u2010group differences in number of hypoglycaemic events were observed.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n BIAsp 30 plus metformin was non\u2010inferior to BIAsp 30 in safely reducing HbA1c in this study.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.13454","type":"journal-article","created":{"date-parts":[[2018,7,2]],"date-time":"2018-07-02T04:36:26Z","timestamp":1530506186000},"page":"2740-2747","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A randomized, open\u2010label, multicentre, parallel\u2010controlled study comparing the efficacy and safety of biphasic insulin aspart 30 plus metformin with biphasic insulin aspart 30 monotherapy for type 2 diabetes patients inadequately controlled with oral antidiabetic drugs: The merit study"],"prefix":"10.1111","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6863-1798","authenticated-orcid":false,"given":"Lixin","family":"Guo","sequence":"first","affiliation":[{"name":"Department of Endocrinology Beijing Hospital, National Center of Gerontology Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Endocrinology Qilu Hospital of Shandong University Jinan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Baocheng","family":"Chang","sequence":"additional","affiliation":[{"name":"Key Laboratory of Hormones and Development, Ministry of Health, Tianjin Key Laboratory of Metabolic Diseases Tianjin Medical University Metabolic Diseases Hospital Tianjin China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liyong","family":"Yang","sequence":"additional","affiliation":[{"name":"The Endocrinology Department The First Affiliated Hospital of Fujian Medical University Fuzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu","family":"Liu","sequence":"additional","affiliation":[{"name":"Sir Run Run Shaw Hospital of Nanjing Medical University Jiangsu China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bo","family":"Feng","sequence":"additional","affiliation":[{"name":"Shanghai East Hospital affiliated to Tongji University Shanghai 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