A 2-way cross-over,open-labeled trial to compare efficacy and safety of insulin Aspart and Novolin R delivered with CSII in 21 Chinese diabetic patients  

作　　者：BI Yu-fang ZHAO Lie-bin LI Xiao-ying WANG Wei-qing SUN Shou-yue CHEN Yu-hong HONG Jie SU Ting-wei LIU Jian-min NING Guang 

机构地区：[1]Shanghai Clinical Center for Endocrine and Metabolic Diseases, Shanghai Institute of Endocrinology and Metabolism, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China

出　　处：《Chinese Medical Journal》2007年第19期1700-1703,共4页中华医学杂志（英文版）

基　　金：This research was supported by Natural Science Foundation of China(No.30270625).

摘　　要：Background Subcutaneous absorption is accelerated by the monomeric conformation of insulin Aspart, which provides good glycemic control with a lower risk of hypoglycemia and less body weight increase. In the present study we investigated the efficacy and safety of a rapid-acting human insulin analogue （insulin Aspart） delivered with continuous subcutaneous insulin infusion （CSII） into Chinese diabetic patients. Methods A total of 21 patients with type 1 or type 2 diabetes were recruited for the 2-way cross-over, open-labeled trial, and then randomized to Group A （n=-10, treated with insulin Aspart） or Group B （n=11, treated with Novolin R）. Insulin Aspart and Novolin R were administered by CSII. Capillary glucose concentrations were measured at 8 time points, pre-prandial and postprandial, bedtime （10 pm）, midnight （2 am） every day during the treatment. Results The average capillary glucose profiles for the day were much better controlled in Group A than in Group B （P〈0.01）. The blood glucose levels were particularly better controlled in Group A than in Group B at pre-breakfast （（6.72±1.24） mmol/L vs （7.84±1.58） mmol/L, P=0.014）, post-breakfast （（8.96±2.41） mmol/L vs （11.70±3.11） mmol/L, P=0.0028）, post-supper （（8.15±2.10） mmol/L vs （10.07±2.36） mmol/L, P=0.008）, bed time （（7.73±1.72） mmol/L vs （9.39±.2.05） mmol/L, P=0.007） and midnight （（6.32±1.16） mmol/L vs （7.48±1.36） mmol/L, P=0.0049）. There was no significant difference in the frequency of hypoglycemic episodes between the two groups. Conclusion Insulin Aspart results in better control of blood glucose levels than regular human insulin （Novolin R） in diabetic patients during delivery by CSII.Background Subcutaneous absorption is accelerated by the monomeric conformation of insulin Aspart, which provides good glycemic control with a lower risk of hypoglycemia and less body weight increase. In the present study we investigated the efficacy and safety of a rapid-acting human insulin analogue （insulin Aspart） delivered with continuous subcutaneous insulin infusion （CSII） into Chinese diabetic patients. Methods A total of 21 patients with type 1 or type 2 diabetes were recruited for the 2-way cross-over, open-labeled trial, and then randomized to Group A （n=-10, treated with insulin Aspart） or Group B （n=11, treated with Novolin R）. Insulin Aspart and Novolin R were administered by CSII. Capillary glucose concentrations were measured at 8 time points, pre-prandial and postprandial, bedtime （10 pm）, midnight （2 am） every day during the treatment. Results The average capillary glucose profiles for the day were much better controlled in Group A than in Group B （P〈0.01）. The blood glucose levels were particularly better controlled in Group A than in Group B at pre-breakfast （（6.72±1.24） mmol/L vs （7.84±1.58） mmol/L, P=0.014）, post-breakfast （（8.96±2.41） mmol/L vs （11.70±3.11） mmol/L, P=0.0028）, post-supper （（8.15±2.10） mmol/L vs （10.07±2.36） mmol/L, P=0.008）, bed time （（7.73±1.72） mmol/L vs （9.39±.2.05） mmol/L, P=0.007） and midnight （（6.32±1.16） mmol/L vs （7.48±1.36） mmol/L, P=0.0049）. There was no significant difference in the frequency of hypoglycemic episodes between the two groups. Conclusion Insulin Aspart results in better control of blood glucose levels than regular human insulin （Novolin R） in diabetic patients during delivery by CSII.

关 键 词：rapid-acting insulin analogue diabetes mellitus continuous subcutaneous insulin infusion capillary glucose 

分 类 号：R587.1[医药卫生—内分泌]