{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T07:31:06Z","timestamp":1790494266356,"version":"4.1.0"},"reference-count":16,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2019,12,4]],"date-time":"2019-12-04T00:00:00Z","timestamp":1575417600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2020,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To assess the efficacy, insulin dose, safety and immunogenicity when people with type 1 diabetes mellitus switched between MYL\u20101501D and reference insulin glargine (Lantus\u00ae; Sanofi\u2010Aventis US LLC, Bridgewater, New Jersey).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>Eligible participants from INSTRIDE 1 who completed 52\u2009weeks of reference insulin glargine treatment were randomized 1:1 to the reference sequence (n = 63; reference insulin glargine for 36\u2009weeks) or to the treatment\u2010switching sequence (n = 64; MYL\u20101501D [weeks 0\u201312], reference insulin glargine [weeks 12\u201324] and MYL\u20101501D [weeks 24\u201336]). Change in glycated haemoglobin (HbA1c) from baseline to week 36 was the primary efficacy endpoint used to demonstrate equivalence between the two treatment sequences. Secondary endpoints included: change in fasting plasma glucose (FPG), self\u2010monitored blood glucose (SMBG) and insulin dose; immunogenicity; and adverse events, including hypoglycaemia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Mean changes in HbA1c (least squares [LS] mean [SE]) from baseline to week 36 were\u2009\u22120.05 (0.032) and\u2009\u22120.06 (0.034) for the treatment\u2010switching and reference sequences, respectively (LS mean difference 0.01 [95% CI \u22120.085 to 0.101]). Treatment sequences were comparable in terms of secondary endpoints, including FPG, SMBG and insulin dose, and the safety and immunogenicity profiles of the two sequences were similar.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Switching participants between MYL\u20101501D and reference insulin glargine demonstrated equivalent efficacy and similar safety and immunogenicity, showing that people taking reference insulin glargine can safely switch to MYL\u20101501D.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.13904","type":"journal-article","created":{"date-parts":[[2019,11,5]],"date-time":"2019-11-05T23:19:18Z","timestamp":1572995958000},"page":"365-372","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":30,"title":["Efficacy and safety of MYL\u20101501D versus insulin glargine in people with type 1 diabetes mellitus: Results of the INSTRIDE 3 phase 3 switch study"],"prefix":"10.1111","volume":"22","author":[{"given":"Thomas C.","family":"Blevins","sequence":"first","affiliation":[{"name":"Texas Diabetes and Endocrinology  Austin Texas United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abhijit","family":"Barve","sequence":"additional","affiliation":[{"name":"Mylan Inc  Canonsburg Pennsylvania United States"}],"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  Steinhausen Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandeep","family":"Athalye","sequence":"additional","affiliation":[{"name":"Biocon Research Limited  Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Sun","sequence":"additional","affiliation":[{"name":"Mylan Inc  Canonsburg Pennsylvania United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafael","family":"Muniz","sequence":"additional","affiliation":[{"name":"Mylan Inc  Canonsburg Pennsylvania United States"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,12,4]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc17-S005"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc17-S009"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199309303291401"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa052187"},{"key":"e_1_2_9_6_1","volume-title":"Bridgewater","author":"Lantus [package insert]","year":"2015"},{"key":"e_1_2_9_7_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_9_8_1","doi-asserted-by":"publisher","DOI":"10.4161\/mabs.3.2.15005"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdm345"},{"key":"e_1_2_9_10_1","unstructured":"European Medicines Agency.Biosimilars in the EU: information guide for healthcare professionals.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Leaflet\/2017\/05\/WC500226648.pdf. 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