Comparison of the efficacy and safety of two kinds of mixed protamine Zinc recombinant human insulin lispro injection (50R) in the treatment of diabetes: a multicenter, randomized, parallel, positive controlled clinical trial
Zhang Xianbo, Bian Fang, Wang Haifang, Liu Lijun, Li Bo, Fu Wenyan, Liu Jie, Su Xiuhai, Shi Huamin, Dai Wu, Liu Changmei, Li Shu, Pang Shuguang, Hu Wen, Shao Huige, Xiao Jianzhong, Dong Qijuan, Li Jin, Ye Shandong, Sun Qingyuan, Sun Li, Wang Kun, Liu Ruiyun, Yuan Huijuan, Sun Fengjuan, Du Ruiqin, Chen Libo, Li Ziling, Wang Dongji, Lou Xueyong, Li Qingbo, Li Hongmei, Li Jianwei, Wang Shuping, Yang Tao, Wang Su, Guo Lixin
Abstract
ObjectiveTo compare the efficacy and safety of Mixed Protamine Zinc Recombinant Human Insulin Lispro Injection (50R) (WANBANG) and Humalog Mix 50 (Lilly) in the treatment of type 2 diabetes mellitus (T2DM).
MethodsA multicenter, randomized, parallel, positive control, phase Ⅲ clinical trial was conducted. From August 30, 2018 to May 27, 2020, 612 patients with T2DM with poor glycemic control by oral hypoglycemic agents were enrolled from 36 centers nationwide, and were followed random number method assigned to the experimental group (WANBANG) and the control group (Lilly) according to 1∶1 for 16 weeks. The glycated hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), 2-hour postprandial glucose (2hPG), body weight, blood lipid, HbA1c compliance rate at the end, the incidence of hypoglycemic events and adverse events and the positive rate of insulin antibody were compared between the two groups before and after treatment.
ResultsOf the 612 patients, 609 were included in the safety data set, including 305 in the experimental group and 304 in the control group; 534 cases were enrolled into the protocol set, including 267 cases in the experimental group and 267 cases in the control group. After 16 weeks of treatment, HbA1c decreased by 1.85%±1.23% and 1.90%±1.27%, respectively. FPG decreased by (3.56±2.99) and (3.72±3.26) mmol/L, 2hPG decreased by (6.94±5.41) and (7.07±5.10) mmol/L, respectively, there was no significant difference in the above indexes between the two groups (P>0.05). There was no significant difference in the overall incidence of hypoglycemia [51.15% (156/305) vs. 45.72% (139/304)], the incidence of adverse events [76.39% (233/305) vs. 77.63% (236/304)] and the positive conversion rate of insulin antibody [22.85% (61/267) vs. 19.10% (51/267)] between the experimental group and Humalog Mix 50 group (P>0.05).
ConclusionsThe efficacy and safety of Mixed Protamine Zinc Recombinant Human Insulin Lispro Injection 50R (WANBANG) in treating T2DM is similar to that of Humalog Mix 50, and is well tolerated. This study has positive significance for reducing the medical burden of the country.
Key words:
Diabetes mellitus, type 2; Randomized controlled trial; Mixed human insulin
Contributor Information
Zhang Xianbo
Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Beijing 100730, China
Bian Fang
Department of Endocrinology, Cangzhou People′s Hospital, Cangzhou 061001, China
Wang Haifang
Department of Endocrinology, Handan First Hospital, Handan 056002, China
Liu Lijun
Department of Endocrinology, Yiyang Central Hospital, Yiyang 413099, China
Li Bo
Department of Endocrinology, Fourth Affiliated Hospital to Harbin Medical University, Harbin 150001, China
Fu Wenyan
Department of Endocrinology, Tonghua Central Hospital, Tonghua 134099, China
Liu Jie
Department of Endocrinology, First Affiliated Hospital to Henan University of Science and Technology, Luoyang 471003, China
Su Xiuhai
Department of Endocrinology, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Cangzhou 061012, China
Shi Huamin
Department of Endocrinology, Puyang Oilfield General Hospital, Puyang 457001, China
Dai Wu
Department of Endocrinology, Hefei Second People′s Hospital, Hefei 230012, China
Liu Changmei
Department of Endocrinology, Affiliated Hospital to Binzhou Medical College, Binzhou 256699, China
Li Shu
Department of Endocrinology, Huizhou Central People′s Hospital, Huizhou 516008, China
Pang Shuguang
Department of Endocrinology, Jinan Central Hospital, Jinan 250013, China
Hu Wen
Department of Endocrinology, Huai′an Second People′s Hospital, Huaian 223022, China
Shao Huige
Department of Endocrinology, Changsha Central Hospital, Changsha 410018, China
Xiao Jianzhong
Department of Endocrinology, Beijing Tsinghua Changgung Hospital, Beijing 102218, China
Dong Qijuan
Department of Endocrinology, Zhengzhou People′s Hospital, Zhengzhou 450053, China
Li Jin
Department of Endocrinology, Zibo Central Hospital, Zibo 255020, China
Ye Shandong
Department of Endocrinology, Anhui Provincial Hospital, Hefei 230002, China
Sun Qingyuan
Department of Endocrinology, Yueyang First People′s Hospital, Yueyang 414020, China
Sun Li
Department of Endocrinology, Siping Central People′s Hospital, Siping 136099, China
Wang Kun
Department of Endocrinology, Nanjing Jiangning Hospital, Nanjing 211199, China
Liu Ruiyun
Department of Endocrinology, Baoding First Traditional Chinese Medicine Hospital, Baoding 071066, China
Yuan Huijuan
Department of Endocrinology, Henan Provincial People′s Hospital, Zhengzhou 450003, China
Sun Fengjuan
Department of Endocrinology, Jining First People′s Hospital, Jining 272002, China
Du Ruiqin
Department of Endocrinology, Chinese People′s Liberation Army Rocket Army General Hospital, Beijing 100088, China
Chen Libo
Department of Endocrinology, Huazhong University of Science and Technology Union Shenzhen Hospital,Shenzhen 518052, China
Li Ziling
Department of Endocrinology, Inner Mongolia Baotou Steel Hospital, Baotou 014010, China
Wang Dongji
Department of Endocrinology, Lianyungang Hospital of Traditional Chinese Medicine, Lianyungang 222001, China
Lou Xueyong
Department of Endocrinology, Jinhua Central Hospital, Jinhua 321099, China
Li Qingbo
Department of Endocrinology, Luoyang First Traditional Chinese Medicine Hospital, Luoyang 471099, China
Li Hongmei
Department of Endocrinology, Emergency General Hospital, Beijing 100028, China
Li Jianwei
Department of Endocrinology, West China Hospital of Sichuan University, Chengdu 610044, China
Wang Shuping
Department of Endocrinology, Dongying People′s Hospital, Dongying 257091, China
Yang Tao
Department of Endocrinology, First Affiliated Hospital with Nanjing Medical University (Jiangsu Provincial Hospital), Nanjing 210029, China
Wang Su
Department of Endocrinology, Tianjin Fifth Central Hospital, Tianjin 300450, China
Guo Lixin
Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Beijing 100730, China
