{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,2]],"date-time":"2026-01-02T08:16:22Z","timestamp":1767341782283,"version":"3.48.0"},"reference-count":29,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T00:00:00Z","timestamp":1763683200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Diabetes Invest"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To compare the efficacy and safety of insulin degludec\/insulin aspart biosimilar B01711 (HS\u2010IDegAsp) with originator insulin degludec\/insulin aspart\u2010Ryzodeg (NN\u2010IDegAsp) in Chinese patients with type 2 diabetes mellitus (T2DM) who were inadequately controlled on once\u2010 or twice\u2010daily (BID) premixed or basal insulin \u00b1 oral antidiabetic drugs (OADs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      In this multicenter, randomized, open\u2010label, parallel\u2010group, active\u2010controlled, phase 3 study, 367 participants with T2DM were randomized 1:1 to receive BID injections of HS\u2010IDegAsp (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009183) or NN\u2010IDegAsp (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009184) for 24\u2009weeks. Insulins were administered subcutaneously with breakfast and the main evening meal at the same titration target. The primary endpoint was the change from baseline in glycated hemoglobin (HbA\n                      <jats:sub>1c<\/jats:sub>\n                      ) to week 24.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At Week 24, the least squares (LS) mean change in HbA\n                      <jats:sub>1c<\/jats:sub>\n                      from baseline was \u22121.12% (95% CI \u22121.24 to \u22121.01) and \u22121.23% (95% CI \u22121.34 to \u22121.11) with HS\u2010IDegAsp and NN\u2010IDegAsp, respectively. The LS mean difference (HS\u2010IDegAsp minus NN\u2010IDegAsp) at Week 24 was 0.10% (95% CI \u22120.06 to 0.27), demonstrating that HS\u2010IDegAsp was non\u2010inferior to NN\u2010IDegAsp. There was no statistically significant difference (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&gt;\u20090.05) in fasting plasma glucose or proportion of patients achieving HbA\n                      <jats:sub>1c<\/jats:sub>\n                      \u2009&lt;\u20097.0% at Week 24 between both groups. Safety and immunogenicity were similar between both groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>HS\u2010IDegAsp demonstrated comparable efficacy and safety to NN\u2010IDegAsp during the 24\u2010week treatment period in Chinese patients with inadequately controlled T2DM previously treated on once\u2010 or twice\u2010daily premixed or basal insulin, with or without OADs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jdi.70175","type":"journal-article","created":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T17:39:19Z","timestamp":1763746759000},"page":"42-50","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of insulin degludec\/insulin aspart biosimilar\n                    <scp>B01711<\/scp>\n                    vs originator insulin degludec\/insulin aspart in Chinese patients with type 2 diabetes inadequately controlled on basal or premixed insulin: A multicenter, randomized, open\u2010label, phase 3 study"],"prefix":"10.1111","volume":"17","author":[{"given":"Leili","family":"Gao","sequence":"first","affiliation":[{"name":"Department of Endocrinology and Metabolism Peking University People's Hospital  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhifeng","family":"Cheng","sequence":"additional","affiliation":[{"name":"Fourth Affiliated Hospital of Harbin Medical University  Harbin China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guoqing","family":"Ma","sequence":"additional","affiliation":[{"name":"The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine  Harbin China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaojun","family":"Cai","sequence":"additional","affiliation":[{"name":"Traditional Chinese Medicine Academy of Heilongjiang  Harbin China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaoyun","family":"Wang","sequence":"additional","affiliation":[{"name":"Cangzhou Hospital of Integrated TCM\u2010WM Hebei  Cangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yibing","family":"Lu","sequence":"additional","affiliation":[{"name":"The Second Affiliated Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ziling","family":"Li","sequence":"additional","affiliation":[{"name":"Baogang Hospital of Inner Mongolia  Baotou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Li","sequence":"additional","affiliation":[{"name":"Yanan University Affiliated Hospital  Yanan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuping","family":"Zhao","sequence":"additional","affiliation":[{"name":"Tonghua Central Hospital  Tonghua China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xuefeng","family":"Li","sequence":"additional","affiliation":[{"name":"Taihe Hospital  Shiyan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chengwei","family":"Song","sequence":"additional","affiliation":[{"name":"Jilin Province FAW General Hospital  Changchun China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yunming","family":"Gao","sequence":"additional","affiliation":[{"name":"The Second People's Hospital of Lianyungang  Lianyungang China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jianlin","family":"Geng","sequence":"additional","affiliation":[{"name":"Harrison International Peace Hospital  Hengshui China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haiyan","family":"Cao","sequence":"additional","affiliation":[{"name":"Hui Sheng Bio\u2010pharmaceutical Co., Ltd  Meihekou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jingfang","family":"Sun","sequence":"additional","affiliation":[{"name":"Hui Sheng Bio\u2010pharmaceutical Co., Ltd  Meihekou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linong","family":"Ji","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Metabolism Peking University People's Hospital  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,21]]},"reference":[{"volume-title":"IDF Diabetes Atlas","year":"2021","author":"International Diabetes Federation","key":"e_1_2_8_2_1"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-S004"},{"issue":"1","key":"e_1_2_8_4_1","first-page":"S140","article-title":"9. 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