Lispro administered by the QS-M Needle-Free Jet Injector generates an earlier insulin exposure.
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.



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.



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.



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.
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Jinbo
J
Hu
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Hui
H
Shi
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Changhong
C
Zhao
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Xiyue
X
Li
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Yue
Y
Wang
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Qingfeng
Q
Cheng
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Richa
R
Goswami
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Qianna
Q
Zhen
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Mei
M
Mei
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Ying
Y
Song
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Shumin
S
Yang
a Department of Endocrinology , The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Qifu
Q
Li
D000328:Adult; D019540:Area Under Curve; D001786:Blood Glucose / Q000187:drug effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D015309:Glucose Clamp Technique; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D061268:Insulin Lispro / Q000008:administration & dosage*; D008297:Male; D009339:Needles; D055815:Young Adult
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D061268:Insulin Lispro
Pharmacokinetic; QS-M needle-free jet injector; insulin lispro; pharmacodynamic