The Pharmacokinetic And Pharmacodynamic(pk-pd)profiles Of Lispro Administered By The QS-M Needle-free Jet Injector In Chinese Subjects:a Randomized,Double-blind,double-dummy,Cross-over Study

Objective: The aim of this study is to evaluate the pharmacokinetic and pharmacodynamic(PK-PD)profiles of lispro administered by the QS-M needle-free jet injector in Chinese subjects.Research design and methods: A randomized,double-blind,double-dummy,cross-over study was performed.Eighteen healthy volunteers were recruited.Lispro(0.2 units/kg)was administered by the QS-M needle-free jet injector or by conventional pen.Seven-hour euglycemic clamp tests were performed.Results: A larger area under the curve(AUCs)of insulin concentration and glucose infusion rate(GIR)during the first 20 minutes after lispro injection by the jet injector compared to the insulin pen was observed(24.91 ± 15.25 vs.12.52 ± 7.60 mg.kg-1,P < 0.001 for AUCGIR,0–20 min;0.36 ± 0.24 vs.0.10 ± 0.04 U min L-1,P < 0.001 for AUCINS,0–20 min).Needle-free injection showed a shorter time to reach maximum insulin concentration(37.78 ± 11.14 vs.80.56 ± 37.18 min,P < 0.001)and GIR(73.24 ± 29.89 vs.116.18 ± 51.89 min,P = 0.006).There were no differences in total insulin exposure and hypoglycemic effects between the two devices.Conclusion: Lispro administered by QS-M needle-free injector results in earlier and higher insulin exposure than conventional pen,and a greater early glucose-lowering effect with similar overall potency.