{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T05:54:13Z","timestamp":1790402053525,"version":"4.1.0"},"reference-count":22,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,9,4]],"date-time":"2018-09-04T00:00:00Z","timestamp":1536019200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100007777","name":"Biocon","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007777","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":[[2019,1]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To assess the non\u2010inferiority of MYL\u20101501D, a proposed biosimilar or follow\u2010on biological agent to marketed insulin glargine, to reference insulin glargine (Lantus\u00ae; Sanofi\u2010Aventis US LLC, Bridgewater, New Jersey) based on change in glycated hemoglobin (HbA1c).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>INSTRIDE 2 was a multicentre, open\u2010label, randomized, parallel\u2010group, phase III non\u2010inferiority study comparing the efficacy and safety of MYL\u20101501D with those of reference insulin glargine in insulin\u2010naive and insulin\u2010non\u2010naive patients with type 2 diabetes mellitus receiving oral antidiabetic drugs (OADs). The primary efficacy endpoint was change in HbA1c from baseline to week 24. Secondary endpoints included metabolic readouts (eg, changes in fasting plasma glucose, insulin dosage, self\u2010monitored blood glucose), immunogenicity and adverse events, including hypoglycaemia and nocturnal hypoglycaemic events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In all, 560 patients were randomized to MYL\u20101501D or insulin glargine in combination with OADs for 24\u2009weeks. The mean change in HbA1c from baseline to week 24 was \u22120.60% (95% CI \u22120.78, \u22120.41) and\u2009\u2212\u20090.66% (95% CI \u22120.84, \u22120.48) for MYL\u20101501D and reference insulin glargine, respectively. MYL\u20101501D was well tolerated and had a safety profile similar to that of reference insulin glargine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Demonstration of non\u2010inferiority between MYL\u20101501D and reference insulin glargine for reduction of HbA1c during 24\u2009weeks of treatment was achieved. The two treatment groups were similar in terms of secondary endpoints, including hypoglycaemia and nocturnal hypoglycaemia, local and systemic reactions, other safety variables, and immunogenicity.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.13495","type":"journal-article","created":{"date-parts":[[2018,8,16]],"date-time":"2018-08-16T02:03:10Z","timestamp":1534384990000},"page":"129-135","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Efficacy and safety of MYL\u20101501D versus insulin glargine in patients with type 2 diabetes after 24 weeks: Results of the phase III INSTRIDE 2 study"],"prefix":"10.1111","volume":"21","author":[{"given":"Thomas C.","family":"Blevins","sequence":"first","affiliation":[{"name":"Texas Diabetes and Endocrinology  Austin Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abhijit","family":"Barve","sequence":"additional","affiliation":[{"name":"Mylan Inc  Canonsburg Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Sun","sequence":"additional","affiliation":[{"name":"Mylan Inc  Canonsburg Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaron","family":"Raiter","sequence":"additional","affiliation":[{"name":"Mylan EPD  Amstelveen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Aubonnet","sequence":"additional","affiliation":[{"name":"Mylan EPD  Allschwil Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafael","family":"Muniz","sequence":"additional","affiliation":[{"name":"Mylan Inc  Canonsburg Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandeep","family":"Athalye","sequence":"additional","affiliation":[{"name":"Biocon Research Ltd  Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Ankersen","sequence":"additional","affiliation":[{"name":"Mylan Inc  Canonsburg Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,9,4]]},"reference":[{"key":"e_1_2_6_2_1","first-page":"e78","volume-title":"Cecil Medicine","author":"Inzucchi SE","year":"2011"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc17-S005"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-2441"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc09-S318"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc17-S011"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ctrv.2016.04.003"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.3390\/ph7050530"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.3390\/ph7090943"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.4161\/mabs.3.2.15005"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.3322\/canjclin.56.4.226"},{"key":"e_1_2_6_12_1","first-page":"270","article-title":"Biosimilars: part 1: proposed regulatory criteria for FDA approval","volume":"38","author":"Ventola CL","year":"2013","journal-title":"P T"},{"key":"e_1_2_6_13_1","first-page":"469","article-title":"The economics of biosimilars","volume":"6","author":"Blackstone EA","year":"2013","journal-title":"Am Health Drug Benefits"},{"key":"e_1_2_6_14_1","unstructured":"US Food and Drug Administration. 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