Assessment the equivalence of the bioanalogue insulin lizpro biphasic 25 (Geropharm-bio, Russia) and Humalog® Mix 25 (Lilly France, France) using the euglycemic hyperinsulinum clamp method on healthy volonters

Background: Modern medicine requires use of effective antidiabetic drugs that can imitate the natural profile of insulin in the body of patients with diabetes mellitus. Examples of such preparations include biphasic insulin lispro, which is a mixture of insulin lispro ultra-short action and insulin...

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Autores principales:	Alexander Y. Mayorov, Ekaterina O. Koksharova, Ekaterina E. Mishina, Roman V. Drai, Olga I. Avdeeva, Igor E. Makarenko
Formato:	article
Lenguaje:	EN RU
Publicado:	Endocrinology Research Centre 2018
Materias:	insulin lispro biosimilar clinical trials pharmacokinetics pharmacodynamics comparability hyperinsulinemic euglycemic clamp Nutritional diseases. Deficiency diseases RC620-627
Acceso en línea:	https://doaj.org/article/07ba711824f147319dd77765ca8b606e
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spelling	oai:doaj.org-article:07ba711824f147319dd77765ca8b606e2021-11-14T09:00:22ZAssessment the equivalence of the bioanalogue insulin lizpro biphasic 25 (Geropharm-bio, Russia) and Humalog® Mix 25 (Lilly France, France) using the euglycemic hyperinsulinum clamp method on healthy volonters2072-03512072-037810.14341/DM9802https://doaj.org/article/07ba711824f147319dd77765ca8b606e2018-12-01T00:00:00Zhttps://www.dia-endojournals.ru/jour/article/view/9802https://doaj.org/toc/2072-0351https://doaj.org/toc/2072-0378Background: Modern medicine requires use of effective antidiabetic drugs that can imitate the natural profile of insulin in the body of patients with diabetes mellitus. Examples of such preparations include biphasic insulin lispro, which is a mixture of insulin lispro ultra-short action and insulin lispro protamine suspension with prolonged effect. The clinical trials (CT) program for biosimilar insulins contains pharmacology studies: pharmacokinetics (PK), pharmacodynamics (PD) and clinical safety studies. Aims: To demonstrate Biphasic Insulin Lispro 25, suspension for subcutaneous administration, 100 U/ml (GEROPHARM-Bio, Russia) and Humalog® Mix 25, suspension for subcutaneous administration, 100 U/ml (Lilly France, France) have comparable pharmacokinetic profiles under conditions of hyperinsulinemic euglycemic clamp (HEC) in healthy volunteers. Materials and methods: The study was conducted on 48 healthy men aged between 18 to 50 years. This was a double-blind, randomized, crossover study of comparative pharmacokinetics of drugs. The investigational products (IP) were administered before the clamp in a single dose of 0.4 U/kg subcutaneously in the abdominal wall. Regular blood sampling was performed during the study. The insulin concentrations in the samples were determined using an ELISA method. The results of the determination were used to calculate the PK parameters and construct the concentration-time curves. Adjust glucose infusion rates were based on blood glucose measurements. These data were used to calculate the PD parameters. Results: Our results demonstrated that Biphasic Insulin Lispro 25 and Humalog® Mix 25 have comparable PK and PD profiles under conditions of HEC in healthy volunteers. The confidence intervals for the ratio of the geometric mean for Cins.max and AUCins.0–12 were 87.75–99.90% and 83.76–96.98% respectively, which were well within 80–125% limits for establishing comparability. Conclusions: Biphasic Insulin Lispro 25 and Humalog® Mix 25 are equivalent based on this CT applying the HEC technique in healthy volunteers.Alexander Y. MayorovEkaterina O. KoksharovaEkaterina E. MishinaRoman V. DraiOlga I. AvdeevaIgor E. MakarenkoEndocrinology Research Centrearticleinsulin lisprobiosimilarclinical trialspharmacokineticspharmacodynamicscomparabilityhyperinsulinemic euglycemic clampNutritional diseases. Deficiency diseasesRC620-627ENRUСахарный диабет, Vol 21, Iss 6, Pp 462-471 (2018)
institution	DOAJ
collection	DOAJ
language	EN RU
topic	insulin lispro biosimilar clinical trials pharmacokinetics pharmacodynamics comparability hyperinsulinemic euglycemic clamp Nutritional diseases. Deficiency diseases RC620-627
spellingShingle	insulin lispro biosimilar clinical trials pharmacokinetics pharmacodynamics comparability hyperinsulinemic euglycemic clamp Nutritional diseases. Deficiency diseases RC620-627 Alexander Y. Mayorov Ekaterina O. Koksharova Ekaterina E. Mishina Roman V. Drai Olga I. Avdeeva Igor E. Makarenko Assessment the equivalence of the bioanalogue insulin lizpro biphasic 25 (Geropharm-bio, Russia) and Humalog® Mix 25 (Lilly France, France) using the euglycemic hyperinsulinum clamp method on healthy volonters
description	Background: Modern medicine requires use of effective antidiabetic drugs that can imitate the natural profile of insulin in the body of patients with diabetes mellitus. Examples of such preparations include biphasic insulin lispro, which is a mixture of insulin lispro ultra-short action and insulin lispro protamine suspension with prolonged effect. The clinical trials (CT) program for biosimilar insulins contains pharmacology studies: pharmacokinetics (PK), pharmacodynamics (PD) and clinical safety studies. Aims: To demonstrate Biphasic Insulin Lispro 25, suspension for subcutaneous administration, 100 U/ml (GEROPHARM-Bio, Russia) and Humalog® Mix 25, suspension for subcutaneous administration, 100 U/ml (Lilly France, France) have comparable pharmacokinetic profiles under conditions of hyperinsulinemic euglycemic clamp (HEC) in healthy volunteers. Materials and methods: The study was conducted on 48 healthy men aged between 18 to 50 years. This was a double-blind, randomized, crossover study of comparative pharmacokinetics of drugs. The investigational products (IP) were administered before the clamp in a single dose of 0.4 U/kg subcutaneously in the abdominal wall. Regular blood sampling was performed during the study. The insulin concentrations in the samples were determined using an ELISA method. The results of the determination were used to calculate the PK parameters and construct the concentration-time curves. Adjust glucose infusion rates were based on blood glucose measurements. These data were used to calculate the PD parameters. Results: Our results demonstrated that Biphasic Insulin Lispro 25 and Humalog® Mix 25 have comparable PK and PD profiles under conditions of HEC in healthy volunteers. The confidence intervals for the ratio of the geometric mean for Cins.max and AUCins.0–12 were 87.75–99.90% and 83.76–96.98% respectively, which were well within 80–125% limits for establishing comparability. Conclusions: Biphasic Insulin Lispro 25 and Humalog® Mix 25 are equivalent based on this CT applying the HEC technique in healthy volunteers.
format	article
author	Alexander Y. Mayorov Ekaterina O. Koksharova Ekaterina E. Mishina Roman V. Drai Olga I. Avdeeva Igor E. Makarenko
author_facet	Alexander Y. Mayorov Ekaterina O. Koksharova Ekaterina E. Mishina Roman V. Drai Olga I. Avdeeva Igor E. Makarenko
author_sort	Alexander Y. Mayorov
title	Assessment the equivalence of the bioanalogue insulin lizpro biphasic 25 (Geropharm-bio, Russia) and Humalog® Mix 25 (Lilly France, France) using the euglycemic hyperinsulinum clamp method on healthy volonters
title_short	Assessment the equivalence of the bioanalogue insulin lizpro biphasic 25 (Geropharm-bio, Russia) and Humalog® Mix 25 (Lilly France, France) using the euglycemic hyperinsulinum clamp method on healthy volonters
title_full	Assessment the equivalence of the bioanalogue insulin lizpro biphasic 25 (Geropharm-bio, Russia) and Humalog® Mix 25 (Lilly France, France) using the euglycemic hyperinsulinum clamp method on healthy volonters
title_fullStr	Assessment the equivalence of the bioanalogue insulin lizpro biphasic 25 (Geropharm-bio, Russia) and Humalog® Mix 25 (Lilly France, France) using the euglycemic hyperinsulinum clamp method on healthy volonters
title_full_unstemmed	Assessment the equivalence of the bioanalogue insulin lizpro biphasic 25 (Geropharm-bio, Russia) and Humalog® Mix 25 (Lilly France, France) using the euglycemic hyperinsulinum clamp method on healthy volonters
title_sort	assessment the equivalence of the bioanalogue insulin lizpro biphasic 25 (geropharm-bio, russia) and humalog® mix 25 (lilly france, france) using the euglycemic hyperinsulinum clamp method on healthy volonters
publisher	Endocrinology Research Centre
publishDate	2018
url	https://doaj.org/article/07ba711824f147319dd77765ca8b606e
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Assessment the equivalence of the bioanalogue insulin lizpro biphasic 25 (Geropharm-bio, Russia) and Humalog® Mix 25 (Lilly France, France) using the euglycemic hyperinsulinum clamp method on healthy volonters

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