{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T19:54:58Z","timestamp":1791316498390,"version":"4.3.1"},"reference-count":27,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,12,15]],"date-time":"2019-12-15T00:00:00Z","timestamp":1576368000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"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":[[2020,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To report phase 1 bioequivalence results comparing MYL\u20101501D, US reference insulin glargine (US IG), and European reference insulin glargine (EU IG).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>\n                      The double\u2010blind, randomized, three\u2010way crossover study compared the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of MYL\u20101501D, US IG and EU IG. In total, 114 patients with type 1 diabetes (T1DM) received 0.4\u2009U\/kg of each study treatment under automated euglycaemic clamp conditions. Insulin metabolite M1 concentrations, insulin glargine (IG) and glucose infusion rates (GIRs) were assessed over 30\u2009hours. Primary PK endpoints were area under the serum IG concentration\u2013time curve from 0 to 30\u2009hours (AUC\n                      <jats:sub>ins.0\u201330h<\/jats:sub>\n                      ) and maximum serum IG concentration (C\n                      <jats:sub>ins.max<\/jats:sub>\n                      ). Primary PD endpoints were area under the GIR\u2013time curve from 0 to 30\u2009hours (AUC\n                      <jats:sub>GIR0\u201330h<\/jats:sub>\n                      ) and maximum GIR (GIR\n                      <jats:sub>max<\/jats:sub>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Bioequivalence among MYL\u20101501D, US IG and EU IG was demonstrated for the primary PK and PD endpoints. Least squares mean ratios were close to 1, and 90% confidence intervals were within 0.80 to 1.25. The PD GIR\u2013time profiles were nearly superimposable. There were no noticeable differences in the safety profiles of the three treatments, and no serious adverse events were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Equivalence with regard to PK and PD characteristics was shown among MYL\u20101501D, US IG and EU IG in patients with T1DM, and each treatment was well tolerated and safe.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.13919","type":"journal-article","created":{"date-parts":[[2019,11,14]],"date-time":"2019-11-14T01:40:21Z","timestamp":1573695621000},"page":"521-529","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Pharmacokinetic and pharmacodynamic bioequivalence of proposed biosimilar MYL\u20101501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus"],"prefix":"10.1111","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8346-2037","authenticated-orcid":false,"given":"Tim","family":"Heise","sequence":"first","affiliation":[{"name":"Profil  Neuss Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Donnelly","sequence":"additional","affiliation":[{"name":"Mylan Inc., Morgantown  West Virginia 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":"Patrick","family":"Aubonnet","sequence":"additional","affiliation":[{"name":"Mylan EPD  Steinhausen Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,12,15]]},"reference":[{"issue":"1","key":"e_1_2_9_2_1","first-page":"S1","article-title":"Standards of medical care in diabetes\u20142017","volume":"40","author":"American Diabetes Association","year":"2017","journal-title":"Diabetes Care"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.28.4.950"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1203858"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g5459"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.21356"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.21364"},{"key":"e_1_2_9_8_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_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdm345"},{"key":"e_1_2_9_10_1","unstructured":"US Food and Drug Administration. Information on biosimilars.https:\/\/wayback.archive-it.org\/7993\/20170404160242\/https:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/HowDrugsareDevelopedandApproved\/ApprovalApplications\/TherapeuticBiologicApplications\/Biosimilars\/default.htm. Accessed August 11 2017."},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/9780470259818.ch2"},{"key":"e_1_2_9_12_1","unstructured":"European Medicines Agency. Guideline on non\u2010clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2015\/03\/WC500184161.pdf. Accessed December 15 2017."},{"key":"e_1_2_9_13_1","unstructured":"Lantus [package insert]. 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Efficacy and safety of MYL\u20101501D versus insulin glargine in patients with type 1 diabetes mellitus: results of the INSTRIDE 3 phase 3 switch study.Diabetes Obes Metab. 2019.https:\/\/doi.org\/10.1111\/dom.13904. 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