Aims

The aim of RHINE-1, a double-blind, randomized, two-treatment, two-period, two-sequence crossover study, was to establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Insulin-R (Biocon's Insulin-R) and Humulin® R (Eli Lilly and Company, USA). Short-acting human insulin (Human Insulin-R) is prandial insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Methods

In this automated euglycemic glucose clamp study, 42 healthy subjects were randomized (1:1) to receive a single dose of 0.3 IU/kg of Biocon's Insulin-R and Humulin® R. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 12 hours. Primary PK endpoints were area under the insulin concentration-time curve from 0 to 12 hours (AUCins.0-12h) and maximum insulin concentration (Cins.max). Primary PD endpoints were area under the GIR time curve from 0 to 12 hours (AUCGIR.0-12h) and maximum GIR (GIRmax).

Results

Equivalence was demonstrated between Biocon's Insulin-R and Humulin® R for the primary PK and PD endpoints. The 90% confidence intervals were within 80.00% to 125.00% limits. The PK and PD profiles were comparable. There were no significant differences in the safety profiles of the two treatments, and no serious adverse events were reported.

Conclusion

PK and PD equivalence was demonstrated between Biocon's Insulin-R and Humulin® R in healthy subjects. Treatment with Biocon's Insulin-R and Humulin® R was well tolerated.

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