A randomized pharmacokinetic and pharmacodynamic trial of two regular human insulins demonstrates bioequivalence in type 1 diabetes and availability of biosimilar insulin may improve access to this medication

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dc.creatorVencio, Sérgio Alberto Cunha
dc.creatorVencio, Rafael Caiado Caixeta
dc.creatorCaixeta, Leonardo Ferreira
dc.creatorMasierek, Małgorzata
dc.creatorMlynarski, Wojciech
dc.creatorDrzewoski, Józef
dc.creatorGregory, Justin M.
dc.date.accessioned2025-01-28T13:57:40Z
dc.date.available2025-01-28T13:57:40Z
dc.date.issued2022
dc.description.abstractAims To compare the pharmacokinetic (PK) and pharmacodynamic (PD) effects and safety of therapeutic dosages of a regular insulin (experimental drug) produced by Bioton S.A. (Warsaw, Poland) versus Humulin® R, a regular insulin (reference drug) produced by Eli Lilly (Indianapolis, Indiana). Materials and Methods In a single-centre, randomized, double-blinded phase 1 crossover study, we used the manual euglycaemic clamp technique to compare PK and PD profiles between single subcutaneous doses (0.3 units/kg) of the two regular insulins in participants with type 1 diabetes (T1DM) with a washout period of 14 (± 7) days between tests. Results We evaluated 56 participants. The mean participant age and body mass index were 32.9 years and 22.9 kg/m2, respectively. The ratios (experimental/reference) of the geometric means of maximum plasma insulin concentration and for plasma insulin area under the curve (AUC) were 0.909 (90% confidence interval [CI] 0.822-1.01) and 0.993 (90% CI 0.944-1.04), respectively. The ratios of the geometric means of maximum glucose infusion rate (GIR) and for GIR AUC were 0.999 (95% CI 0.912-1.09) and 1.04 (95% CI 0.962-1.12), respectively. Conclusions The experimental product regular human insulin and comparator Humulin® R are bioequivalent in patients with T1DM. Wider entry to the pharmaceutical market of affordable, biosimilar regular insulins may substantially improve access to insulin for many socioeconomically disadvantaged patients with diabetes.
dc.identifier.citationVENCIO, Sérgio et al. A randomized pharmacokinetic and pharmacodynamic trial of two regular human insulins demonstrates bioequivalence in type 1 diabetes and availability of biosimilar insulin may improve access to this medication. Diabetes Obesity & Metabolism, Oxford, v. 24, n. 8, p.1544-1552, 2022. DOI: 10.1111/dom.14724. Disponível em: https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.14724. Acesso em: 23 jan. 2025.
dc.identifier.doi10.1111/dom.14724
dc.identifier.issn1462-8902
dc.identifier.issne- 1463-1326
dc.identifier.urihttps://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.14724
dc.language.isoeng
dc.publisher.countryGra-bretanha
dc.publisher.departmentFaculdade de Medicina - FM (RMG)
dc.rightsAcesso Restrito
dc.titleA randomized pharmacokinetic and pharmacodynamic trial of two regular human insulins demonstrates bioequivalence in type 1 diabetes and availability of biosimilar insulin may improve access to this medication
dc.typeArtigo

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