{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["24(9)"],"submitter":["Plum-Morschel L"],"pubmed_abstract":["<h4>Aim</h4>To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar insulin 70/30 (Biocon's Insulin-70/30) and HUMULIN® 70/30 (HUMULIN-70/30; Eli Lilly and Company, IN).<h4>Materials and methods</h4>In this phase 1, automated euglycaemic glucose clamp study, 78 healthy subjects were randomized (1:1) to receive a single dose of 0.4 IU/kg of Biocon's Insulin-70/30 and HUMULIN-70/30. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 24 hours. Primary PK endpoints were area under the insulin concentration-time curve from 0 to 24 hours - AUC<sub>ins.0-24h</sub> - and maximum insulin concentration - C<sub>ins.max</sub> . Primary PD endpoints were area under the GIR time curve from 0 to 24 hours - AUC<sub>GIR.0-24h</sub> - and maximum GIR - GIR<sub>max</sub> .<h4>Results</h4>Equivalence was shown between Biocon's Insulin-70/30 and HUMULIN-70/30 for the primary PK/PD endpoints. The 90% confidence intervals of the treatment ratios were entirely within the acceptance range of 80.00%-125.00%. The secondary PK/PD profiles were also comparable. There were no clinically relevant differences in the safety profiles of the two treatments and no serious adverse events were reported.<h4>Conclusion</h4>PK/PD equivalence was demonstrated between Biocon's Insulin-70/30 and HUMULIN-70/30 in healthy subjects. Treatment with Biocon's Insulin-70/30 and HUMULIN-70/30 was well tolerated."],"journal":["Diabetes, obesity & metabolism"],"pagination":["1819-1828"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9543887"],"repository":["biostudies-literature"],"pubmed_title":["Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin 70/30 with US-licensed HUMULIN® 70/30 formulation in healthy subjects: Results from the RHINE-3 (Recombinant Human INsulin Equivalence-3) study."],"pmcid":["PMC9543887"],"pubmed_authors":["Singh G","Sharma N","Panda J","Klein O","Marwah A","Murugesan SMN","Lakshmi GC","Loganathan S","Plum-Morschel L","Athalye SN"],"additional_accession":[]},"is_claimable":false,"name":"Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin 70/30 with US-licensed HUMULIN® 70/30 formulation in healthy subjects: Results from the RHINE-3 (Recombinant Human INsulin Equivalence-3) study.","description":"<h4>Aim</h4>To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar insulin 70/30 (Biocon's Insulin-70/30) and HUMULIN® 70/30 (HUMULIN-70/30; Eli Lilly and Company, IN).<h4>Materials and methods</h4>In this phase 1, automated euglycaemic glucose clamp study, 78 healthy subjects were randomized (1:1) to receive a single dose of 0.4 IU/kg of Biocon's Insulin-70/30 and HUMULIN-70/30. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 24 hours. Primary PK endpoints were area under the insulin concentration-time curve from 0 to 24 hours - AUC<sub>ins.0-24h</sub> - and maximum insulin concentration - C<sub>ins.max</sub> . Primary PD endpoints were area under the GIR time curve from 0 to 24 hours - AUC<sub>GIR.0-24h</sub> - and maximum GIR - GIR<sub>max</sub> .<h4>Results</h4>Equivalence was shown between Biocon's Insulin-70/30 and HUMULIN-70/30 for the primary PK/PD endpoints. The 90% confidence intervals of the treatment ratios were entirely within the acceptance range of 80.00%-125.00%. The secondary PK/PD profiles were also comparable. There were no clinically relevant differences in the safety profiles of the two treatments and no serious adverse events were reported.<h4>Conclusion</h4>PK/PD equivalence was demonstrated between Biocon's Insulin-70/30 and HUMULIN-70/30 in healthy subjects. Treatment with Biocon's Insulin-70/30 and HUMULIN-70/30 was well tolerated.","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Sep","modification":"2024-11-21T04:26:09.338Z","creation":"2024-11-21T04:26:09.338Z"},"accession":"S-EPMC9543887","cross_references":{"pubmed":["35589611"],"doi":["10.1111/dom.14768"]}}