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

Aims 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) 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/m(2), 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) 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.

Automated summary

This study compared the pharmacokinetic and pharmacodynamic effects of a new insulin produced by Bioton S.A. with Humulin R produced by Eli Lilly. The results showed that both insulins are bioequivalent for treating type 1 diabetes patients.