{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T23:50:42Z","timestamp":1773705042702,"version":"3.50.1"},"reference-count":12,"publisher":"Becaris Publishing Limited","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"published-print":{"date-parts":[[2020,3]]},"abstract":"\n Aim:<\/jats:bold>\n To compare safety (immunogenicity) and efficacy of GP40061 insulin glargine (GP-Gla) and Lantus\n \u00ae<\/jats:sup>\n (Sanofi glargine, Sa-Gla) in people with diabetes mellitus.\n Materials & methods:<\/jats:bold>\n This randomized open-label, 26-week clinical trial enrolled 180 Type 1 diabetes mellitus patients (HbA1c 6.5\u201312.0%), randomized 1:1 to once daily GP-Gla (n\u00a0=\u00a090) or Sa-Gla (n\u00a0=\u00a090). The primary end point was immune response at 26th week.\n Results:<\/jats:bold>\n The frequency of immune response was similar in GP-Gla and Sa-Gla (p\u00a0=\u00a01.000). Groups were similar in terms of other safety end points. Mean HbA1c change from baseline was -0.66% for GP-Gla and -0.77% for Sa-Gla, and did not differ between groups (p\u00a0=\u00a00.326). Insulin doses, fasting plasma glucose\u00a0and seven-point glucose profiles were similar between groups.\n Conclusion:<\/jats:bold>\n GP-Gla and Sa-Gla demonstrated similar safety and efficacy.\n <\/jats:p>\n ClinicalTrials.gov Identifier: NCT04022993<\/jats:p>","DOI":"10.2217\/cer-2019-0136","type":"journal-article","created":{"date-parts":[[2020,2,6]],"date-time":"2020-02-06T15:01:43Z","timestamp":1581001303000},"page":"263-273","source":"Crossref","is-referenced-by-count":9,"title":["Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus\n \u00ae<\/sup>\n ): a randomized open-label clinical trial"],"prefix":"10.57264","volume":"9","author":[{"given":"Tatiana L","family":"Karonova","sequence":"first","affiliation":[{"name":"Institute of Endocrinology, Almazov National Medical Research Center, Saint-Petersburg, Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna A","family":"Mosikian","sequence":"additional","affiliation":[{"name":"Clinical Trials Department, OOO GEROPHARM, Saint-Petersburg, Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander Y","family":"Mayorov","sequence":"additional","affiliation":[{"name":"Diabetes Prognosis and Innovation Department, Endocrinology Research Centre, Moscow, Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Igor E","family":"Makarenko","sequence":"additional","affiliation":[{"name":"Clinical Trials Department, OOO GEROPHARM, Saint-Petersburg, Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Svetlana T","family":"Zyangirova","sequence":"additional","affiliation":[{"name":"Kazan Endocrine Center, Kazan, Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olena A","family":"Afonkina","sequence":"additional","affiliation":[{"name":"Clinical Trials Department, OOO GEROPHARM, Saint-Petersburg, Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatiana M","family":"Belikova","sequence":"additional","affiliation":[{"name":"Clinical Trials Department, OOO GEROPHARM, Saint-Petersburg, Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alsu G","family":"Zalevskaya","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, First Pavlov State Medical University, Saint-Petersburg, Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander L","family":"Khokhlov","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Department, Yaroslavl State Medical University, Yaroslavl, Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roman V","family":"Drai","sequence":"additional","affiliation":[{"name":"Clinical Trials Department, OOO GEROPHARM, Saint-Petersburg, Russia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"36897","reference":[{"issue":"1","key":"e_1_3_5_3_2","doi-asserted-by":"crossref","first-page":"1","DOI":"10.14341\/DM12211","article-title":"Standards of Specialized Diabetes Care. 9th Edition.","volume":"22","author":"Dedov II","year":"2019","unstructured":"Dedov II , Shestakova MV , Mayorov AY Standards of Specialized Diabetes Care. 9th Edition. Diabetes Mellitus 22(1S1), 1\u2013144 (2019).","journal-title":"Diabetes Mellitus"},{"issue":"3","key":"e_1_3_5_4_2","doi-asserted-by":"crossref","first-page":"689","DOI":"10.1111\/dom.13149","article-title":"A European, multicentre, retrospective, non-interventional study (EU-TREAT) of the effectiveness of insulin degludec after switching basal insulin in a population with type 1 or type 2 diabetes","volume":"20","author":"Siegmund T","year":"2018","unstructured":"Siegmund T , Tentolouris N , Knudsen ST A European, multicentre, retrospective, non-interventional study (EU-TREAT) of the effectiveness of insulin degludec after switching basal insulin in a population with type 1 or type 2 diabetes. Diabetes Obes. Metab. 20(3), 689\u2013697 (2018).","journal-title":"Diabetes Obes. Metab."},{"key":"e_1_3_5_5_2","unstructured":"Biosimilar medicines: Overview (EMA).\n https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/biosimilar-medicines-overview"},{"issue":"4","key":"e_1_3_5_6_2","first-page":"3","article-title":"Biosimilar cost savings in the United States: initial experience and future potential","volume":"7","author":"Mulcahy AW","year":"2018","unstructured":"Mulcahy AW , Hlavka JP , Case SR . Biosimilar cost savings in the United States: initial experience and future potential. RAND Health Q. 7(4), 3 (2018).","journal-title":"RAND Health Q."},{"key":"e_1_3_5_7_2","unstructured":"List of currently registered biosimilars in the European Union. https:\/\/www.ema.europa.eu\/en\/medicines\/Human\/ema_group_types\/ema_medicine\/field_ema_med_status\/authorised-36\/ema_medicine_types\/field_ema_med_biosimilar\/search_api_aggregation_ema_medicine_types\/field_ema_med_biosimilar."},{"key":"e_1_3_5_8_2","unstructured":"Resolution No. 89 of November 3 2016 On Approval of the Rules for Conducting Studies of Biologicals in the Eurasian Economic Union Chapter 15.7 Preclinical and clinical development of bioanalogous (biosimilar) medicinal products containing recombinant insulin and insulin analogues."},{"key":"e_1_3_5_9_2","unstructured":"EMA. European Medical Agency.\n Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. EMEA\/CHMP\/BMWP\/32775\/2005_Rev. 1 (2015)."},{"issue":"2","key":"e_1_3_5_10_2","doi-asserted-by":"crossref","first-page":"66","DOI":"10.18544\/PEDM-22.02.0053","article-title":"The honeymoon phase - what we know today about the factors that can modulate the remission period in type 1 diabetes","volume":"22","author":"Soko\u0142owska M","year":"2016","unstructured":"Soko\u0142owska M , Chobot A , Jarosz-Chobot P . The honeymoon phase - what we know today about the factors that can modulate the remission period in type 1 diabetes. Pediatr. Endocrinol. Diabetes Metab. 22(2), 66\u201370 (2016).","journal-title":"Pediatr. Endocrinol. Diabetes Metab."},{"issue":"1","key":"e_1_3_5_11_2","first-page":"1","volume":"20","author":"Dedov II","year":"2017","unstructured":"Dedov II , Shestakova MV , Mayorov AYu Standards of Specialized Diabetes Care. 8th Edition. Diabetes Mellitus 20(S1), 1\u2013121 (2017).","journal-title":"Standards of Specialized Diabetes Care. 8th Edition. 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CPMP\/EWP\/1080\/00 Rev. 1 (2012)."},{"key":"e_1_3_5_14_2","doi-asserted-by":"crossref","first-page":"2191","DOI":"10.1001\/jama.2013.281053","article-title":"World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects","volume":"310","author":"World Medical Association.","year":"2013","unstructured":"World Medical Association.. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. 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