Evaluation of biosimilarity of RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi-Aventis Deutschland GmbH, Germany) using the euglycemic hyperinsulinemic clamp technique in patients with type 1 diabetes: double-blind randomized clinical trial

Background: Prevention of the development of micro-and macrovascular complications in patients with diabetes melli-tus (DM) encouraged the search for insulin analogues that allow imitating, as close as possible, a normal physiological insulin secretion in healthy people. Biosimilars (bioanalogues of...

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Autores principales:	Alexander Y. Mayorov, Roman V. Drai, Tatiana L. Karonova, Olga I. Avdeeva, Igor E. Makarenko, Ekaterina O. Koksharova, Ekaterina Е. Mishina, Yulia А. Sevastyanova, Olena V. Afonkina
Formato:	article
Lenguaje:	EN RU
Publicado:	Endocrinology Research Centre 2020
Materias:	insulin glargin biosimilar pharmacokinetics pharmacodynamics comparability glucose infusion rate ringlar lantus Nutritional diseases. Deficiency diseases RC620-627
Acceso en línea:	https://doaj.org/article/b3a6691ae08b4a68a1b2aa25127806f7
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spelling	oai:doaj.org-article:b3a6691ae08b4a68a1b2aa25127806f72021-11-14T09:00:23ZEvaluation of biosimilarity of RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi-Aventis Deutschland GmbH, Germany) using the euglycemic hyperinsulinemic clamp technique in patients with type 1 diabetes: double-blind randomized clinical trial2072-03512072-037810.14341/DM10095https://doaj.org/article/b3a6691ae08b4a68a1b2aa25127806f72020-12-01T00:00:00Zhttps://www.dia-endojournals.ru/jour/article/view/10095https://doaj.org/toc/2072-0351https://doaj.org/toc/2072-0378Background: Prevention of the development of micro-and macrovascular complications in patients with diabetes melli-tus (DM) encouraged the search for insulin analogues that allow imitating, as close as possible, a normal physiological insulin secretion in healthy people. Biosimilars (bioanalogues of reference products) play an important role in the full provision with high-quality insulin medications throughout patients. The program of clinical trials of insulin bioanalogues includes pharmacology studies: pharmacokinetics (PK), pharmacodynamics (PD) and clinical safety research.Aims: To test whether RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi-Aventis Deutschland GmbH, Germany) have similar PK and PD profiles in a hyperinsulinemic euglycaemic clamp (HEC) setting in patients with type 1 diabetes mellitus. Permission of the Ministry of Health of the Russian Federation No. 150 of 03/03/2016.Materials and methods: The study was conducted in 42 patients with type 1 diabetes aged 18 to 65 years. A doubleblind, randomized, crossover study of comparative PK and PD of drugs was chosen as a study design. The investigational products were injected after achieving a state of euglycemia before the HEC in a single dose of 0.6 U/kg subcutaneously into the subcutaneous fat of the anterior abdominal wall. During the study, regular blood sampling was performed, the amount of insulin glargine in the samples was determined by ELISA. The results are used to calculate the PK parameters and generate the concentration-time curves. The glucose infusion rate was corrected based on the measurement of glycemia. These data are used to calculate the PD parameters.Results: RinGlar® and Lantus® interventions have comparable PK and PD profiles in HEC setting in patients with type 1 diabetes. This is confirmed by the similarity of the main PK/PD parameters, PK/PD curves, and comparable safety. The confidence intervals of the geometric mean ratio were 81.02% - 120.62% for the PK parameter AUCins0-T, and 85.43% - 115.64% for the PD-parameter AUCGIR0_T, which fall within the specified limits of 80% - 125% to establish comparability between drugs.Conclusions: Results of the clinical trial demonstrate the biosimilarity of the products RinGlar® and Lantus®.Alexander Y. MayorovRoman V. DraiTatiana L. KaronovaOlga I. AvdeevaIgor E. MakarenkoEkaterina O. KoksharovaEkaterina Е. MishinaYulia А. SevastyanovaOlena V. AfonkinaEndocrinology Research Centrearticleinsulin glarginbiosimilarpharmacokineticspharmacodynamicscomparabilityglucose infusion rateringlarlantusNutritional diseases. Deficiency diseasesRC620-627ENRUСахарный диабет, Vol 23, Iss 4, Pp 304-315 (2020)
institution	DOAJ
collection	DOAJ
language	EN RU
topic	insulin glargin biosimilar pharmacokinetics pharmacodynamics comparability glucose infusion rate ringlar lantus Nutritional diseases. Deficiency diseases RC620-627
spellingShingle	insulin glargin biosimilar pharmacokinetics pharmacodynamics comparability glucose infusion rate ringlar lantus Nutritional diseases. Deficiency diseases RC620-627 Alexander Y. Mayorov Roman V. Drai Tatiana L. Karonova Olga I. Avdeeva Igor E. Makarenko Ekaterina O. Koksharova Ekaterina Е. Mishina Yulia А. Sevastyanova Olena V. Afonkina Evaluation of biosimilarity of RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi-Aventis Deutschland GmbH, Germany) using the euglycemic hyperinsulinemic clamp technique in patients with type 1 diabetes: double-blind randomized clinical trial
description	Background: Prevention of the development of micro-and macrovascular complications in patients with diabetes melli-tus (DM) encouraged the search for insulin analogues that allow imitating, as close as possible, a normal physiological insulin secretion in healthy people. Biosimilars (bioanalogues of reference products) play an important role in the full provision with high-quality insulin medications throughout patients. The program of clinical trials of insulin bioanalogues includes pharmacology studies: pharmacokinetics (PK), pharmacodynamics (PD) and clinical safety research.Aims: To test whether RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi-Aventis Deutschland GmbH, Germany) have similar PK and PD profiles in a hyperinsulinemic euglycaemic clamp (HEC) setting in patients with type 1 diabetes mellitus. Permission of the Ministry of Health of the Russian Federation No. 150 of 03/03/2016.Materials and methods: The study was conducted in 42 patients with type 1 diabetes aged 18 to 65 years. A doubleblind, randomized, crossover study of comparative PK and PD of drugs was chosen as a study design. The investigational products were injected after achieving a state of euglycemia before the HEC in a single dose of 0.6 U/kg subcutaneously into the subcutaneous fat of the anterior abdominal wall. During the study, regular blood sampling was performed, the amount of insulin glargine in the samples was determined by ELISA. The results are used to calculate the PK parameters and generate the concentration-time curves. The glucose infusion rate was corrected based on the measurement of glycemia. These data are used to calculate the PD parameters.Results: RinGlar® and Lantus® interventions have comparable PK and PD profiles in HEC setting in patients with type 1 diabetes. This is confirmed by the similarity of the main PK/PD parameters, PK/PD curves, and comparable safety. The confidence intervals of the geometric mean ratio were 81.02% - 120.62% for the PK parameter AUCins0-T, and 85.43% - 115.64% for the PD-parameter AUCGIR0_T, which fall within the specified limits of 80% - 125% to establish comparability between drugs.Conclusions: Results of the clinical trial demonstrate the biosimilarity of the products RinGlar® and Lantus®.
format	article
author	Alexander Y. Mayorov Roman V. Drai Tatiana L. Karonova Olga I. Avdeeva Igor E. Makarenko Ekaterina O. Koksharova Ekaterina Е. Mishina Yulia А. Sevastyanova Olena V. Afonkina
author_facet	Alexander Y. Mayorov Roman V. Drai Tatiana L. Karonova Olga I. Avdeeva Igor E. Makarenko Ekaterina O. Koksharova Ekaterina Е. Mishina Yulia А. Sevastyanova Olena V. Afonkina
author_sort	Alexander Y. Mayorov
title	Evaluation of biosimilarity of RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi-Aventis Deutschland GmbH, Germany) using the euglycemic hyperinsulinemic clamp technique in patients with type 1 diabetes: double-blind randomized clinical trial
title_short	Evaluation of biosimilarity of RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi-Aventis Deutschland GmbH, Germany) using the euglycemic hyperinsulinemic clamp technique in patients with type 1 diabetes: double-blind randomized clinical trial
title_full	Evaluation of biosimilarity of RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi-Aventis Deutschland GmbH, Germany) using the euglycemic hyperinsulinemic clamp technique in patients with type 1 diabetes: double-blind randomized clinical trial
title_fullStr	Evaluation of biosimilarity of RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi-Aventis Deutschland GmbH, Germany) using the euglycemic hyperinsulinemic clamp technique in patients with type 1 diabetes: double-blind randomized clinical trial
title_full_unstemmed	Evaluation of biosimilarity of RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi-Aventis Deutschland GmbH, Germany) using the euglycemic hyperinsulinemic clamp technique in patients with type 1 diabetes: double-blind randomized clinical trial
title_sort	evaluation of biosimilarity of ringlar® (geropharm llc, russia) and lantus® (sanofi-aventis deutschland gmbh, germany) using the euglycemic hyperinsulinemic clamp technique in patients with type 1 diabetes: double-blind randomized clinical trial
publisher	Endocrinology Research Centre
publishDate	2020
url	https://doaj.org/article/b3a6691ae08b4a68a1b2aa25127806f7
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Evaluation of biosimilarity of RinGlar® (GEROPHARM LLC, Russia) and Lantus® (Sanofi-Aventis Deutschland GmbH, Germany) using the euglycemic hyperinsulinemic clamp technique in patients with type 1 diabetes: double-blind randomized clinical trial

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