Comparative evaluation of pharmacokinetics and pharmacodynamics of insulin glargine (Glaritus) and Lantus in healthy subjects: a double-blind, randomized clamp study.

AIMS

The objective of the study was to compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an insulin glargine formulation, Glaritus (test) with the innovator's formulation Lantus (reference) using the euglycemic clamp technique in a single-dose, double-blind, randomized, two sequences, four-period replicate crossover study in healthy volunteers (n = 40).

METHODS

Subjects received subcutaneous administration of the insulin glargine (0.4 IU/kg) formulation at two occasions for test and reference and a 20% glucose solution was infused at variable rate to maintain euglycemia for 24 h.

RESULTS

Both PK [area under the plasma concentration time curve (AUC) and maximum insulin concentration (C)] and PD endpoints [area under glucose infusion rate time curve () and maximum glucose infusion rate (GIR)] demonstrated bioequivalence of Glaritus to Lantus with the 90% confidence interval of geometric mean ratio of test to reference entirely contained within 0.80-1.25. Both formulations showed equivalent geometric least-square mean LSM value (0.08 nmol/L) for C. The geometric LSM AUC value for Glaritus (1.09 h nmol/L) was comparable to Lantus (1.05 h nmol/L). Median T values were also identical (12 h for both), and median t1/2 values were also equal (18 h for both). For GIR, the difference between the means for the two was not statistically significant. No AEs related to study formulations were reported, and both products were well tolerated.

CONCLUSIONS

The test product (Glaritus) was found to be bioequivalent to the reference product (Lantus).

CLINICAL TRIAL REGISTRATION NUMBER

CTRI/2015/06/005890; http://www.ctri.nic.in/ .