{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T02:42:04Z","timestamp":1772160124746,"version":"3.50.1"},"reference-count":33,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2021,7,8]],"date-time":"2021-07-08T00:00:00Z","timestamp":1625702400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","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":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) with the reference product (Lantus\u00ae) insulin glargine (IGlar) in Chinese patients with type 1 diabetes mellitus (T1DM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>This phase III, prospective, multicentre, open\u2010label study enrolled patients with T1DM, age \u226518\u2009years, with haemoglobin A1c (HbA1c) \u226411.0%, who were randomized to LY IGlar (n\u00a0=\u00a0137) or IGlar (n\u00a0=\u00a0135) in combination with premeal insulin lispro for 24\u2009weeks. The treatment targets were to achieve HbA1c &lt;7% and preprandial capillary blood glucose 79\u2010126\u2009mg\/dl (4.4\u20107.0\u2009mmol\/L), avoiding hypoglycaemia. The primary efficacy endpoint was testing the non\u2010inferiority of LY IGlar to IGlar by a margin of 0.4% using the mixed model repeated measure approach, as measured by changes in HbA1c levels from baseline to 24\u2009weeks. Continuous laboratory measures were analysed using analysis of covariance. For categorical measures, Fisher's exact test was used.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The least squares mean difference between treatments (LY IGlar \u2013 IGlar) in change from baseline was \u22120.12% (95% confidence interval \u22120.32%, 0.08%), meeting the non\u2010inferiority criteria. There were no clinically meaningful differences (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&gt;\u2009.05) in other efficacy outcomes, including proportions of patients achieving HbA1c &lt;7.0% and HbA1c \u22646.5%, self\u2010monitored blood glucose and insulin dose at week 24. Weight change, insulin antibodies and all adverse events including allergic reactions and hypoglycaemia, were also similar between the two treatment groups (all\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&gt;\u2009.05).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>LY IGlar and IGlar had equivalent efficacy in glycaemic control and similar safety profiles in Chinese patients with T1DM, when used in combination with mealtime insulin lispro.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.14463","type":"journal-article","created":{"date-parts":[[2021,6,14]],"date-time":"2021-06-14T02:17:35Z","timestamp":1623637055000},"page":"2226-2233","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Comparable efficacy and safety between\n                    <scp>LY2963016<\/scp>\n                    insulin glargine and insulin glargine (Lantus\u00ae) in Chinese patients with type 1 diabetes: A phase\n                    <scp>III<\/scp>\n                    , randomized, controlled trial"],"prefix":"10.1111","volume":"23","author":[{"given":"Xiang","family":"Yan","sequence":"first","affiliation":[{"name":"National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology The Second Xiangya Hospital of Central South University  Changsha China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shan","family":"Jiang","sequence":"additional","affiliation":[{"name":"Lilly (Shanghai) Management Co., Ltd  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Lou","sequence":"additional","affiliation":[{"name":"Lilly Suzhou Pharmaceutical Co., Ltd  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0374-1838","authenticated-orcid":false,"given":"Zhiguang","family":"Zhou","sequence":"additional","affiliation":[{"name":"National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology The Second Xiangya Hospital of Central South University  Changsha China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,7,8]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"Diabetes mellitus","author":"Sapra A","year":"2021"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.7257\/1053-816X.2016.36.1.27"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12013-015-0598-4"},{"key":"e_1_2_9_5_1","unstructured":"International Diabetes Federation. 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Levemir\u00ae China label.https:\/\/db.yaozh.com\/instruct\/103081.html."},{"key":"e_1_2_9_15_1","unstructured":"Sanofi\u2010Aventis. Lantus\u00ae China label.https:\/\/db.yaozh.com\/instruct\/103343.html."},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1517\/17425255.4.8.1099"},{"key":"e_1_2_9_17_1","unstructured":"European Medicines Agency. LANTUS: EPAR \u2013 Product information.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/000284\/WC500036082.pdfAccessed April 1 2015."},{"key":"e_1_2_9_18_1","unstructured":"FDA approves Basaglar the first \u201cfollow\u2010on\u201d insulin glargine product to treat diabetes. US Food and Drug Administration.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2015\/205692Orig1s000SumR.pdf2015."},{"key":"e_1_2_9_19_1","unstructured":"European Medicines Agency. 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