Winnonlin version 8

Phoenix© WinNonlin^® Version 8.2 (Pharsight Corporation, Mountain View, CA, USA) was used to analyze serum concentrations of phospholipids and cholesterol vs. time profiles of each micelle formulation. A non-compartmental model was used to obtain pharmacokinetic and pharmacodynamic parameters. The pharmacokinetic parameters obtained from the plot of concentration of phospholipid versus time include the maximum plasma concentration of phospholipid (C_max), area under the curve (AUC), elimination rate constant (K₁₀), half-life of elimination (T_1/2), total clearance of phospholipid (CL), and volume of distribution at steady state (V_ss). The mean and coefficient of variation within each group are presented in the table. The pharmacodynamic parameters derived from total and free cholesterol, and cholesterol ester concentration versus time profiles include the area under the effect curve (AUEC), the maximum plasma concentration (E_max) and the time at which Emax is observed (T_max). The mean and coefficient of variation was calculated for each of the above parameters.

PK comparison in this study was based on the principal component M1, as well as the parent insulin glargine. Pharmacokinetic parameters were calculated with WinNonlin Version 8.2 (Pharsight Corporation, Mountain View, California, United States) using a non-compartmental analysis method. The primary PK parameters were maximum plasma concentration (C_max) and area under the plasma concentration–time curve (AUC_0–24 h). Partial area under the plasma concentration–time curve (AUC_0–12 h and AUC_12–24 h) was a secondary PK parameter. Time to reach C_max (T_max) was also calculated.
C-peptide concentration was measured in parallel to insulin concentrations throughout the experiment to compare the extent and consistency of suppression of endogenous insulin between the two drugs.