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

Acta Diabetologica Feb 23, 2018

Bhatia A, et al. - The authors undertook a comparative scrutiny of the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an insulin glargine formulation, Glaritus (test) with the innovator’s formulation Lantus (reference) with the aid of the euglycemic clamp technique in healthy volunteers. It was determined that both PK [area under the plasma concentration time curve (AUC0–24 h) and maximum insulin concentration (Cmax)] and PD endpoints [area under glucose infusion rate time curve (AUCGIR0–24) and maximum glucose infusion rate (GIRmax)] exhibited bioequivalence of Glaritus to Lantus.
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