Abstract
The aim of this study was to evaluate the pharmacodynamic properties of the novel insulin formulation Viaject™ (VJ). VJ is a formulation of regular human insulin and GRAS ingredients designed to increase the rate of absorption. Five euglycemic glucose-clamps (Biostator; target blood glucose 90mg/dl) were performed in 10 fasting healthy volunteers (age 40 (20–62) years (mean (range)); BMI 22.5 (19.2–24.9)kg/m2). Using a cross-over design with a fixed treatment order, 12 IU Regular insulin (RI), 12 IU Insulin Lispro (IL) and 12, 6 and 3 IU VJ were injected subcutaneously in the abdominal region. SC injection of VJ resulted in a time-action profile that is characterized by an even more rapid rise in glucose consumption than IL: Onset of action (early half-maximal action: VJ 12 IU 33, IL 51, RI 66min) and time to maximal metabolic activity (137, 152, 193min) was observed earlier with Viaject™ than with IL and IL. The metabolic activity in the first 2h after injection was higher with VJ compared to RI (908, 775, 571mg/kg). A clear dose-response relationship was observed with the three doses of VJ with respect to both serum insulin levels and metabolic activity. The pharmacokinetic data confirm the PD results. No clinically significant adverse events were observed. This study shows that the pharmacodynamic effects of Viaject™, a novel formulation of regular insulin, are significantly faster after s.c. injection than regular insulin and rapid-acting insulin analogues.
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