目的:探讨皮下注射重组赖脯胰岛素（江苏万邦生化医药集团有限责任公司生产）治疗糖尿病的疗效性及安全性。方法:本研究为全国多中心、随机、阳性药物平行对照的前瞻性临床试验，于2017年11月至2019年11月从全国29家三甲医院选取糖尿病病程6个月以上、单纯口服降糖药联合或口服降糖药联合胰岛素或单纯胰岛素注射≥2次/d稳定治疗3个月以上，且7.5%≤糖化血红蛋白（HbAn 1c）≤13.0%的糖尿病患者共626例，通过区组随机化方法，按1∶1随机分到试验组（315例）和对照组（311例）。试验组（315例）和对照组（310例，剔除1例）分别给予试验药物重组赖脯胰岛素和阳性对照药物赖脯胰岛素每日3次，联合重组甘精胰岛素每日1次治疗，按规定方案调整胰岛素剂量。比较两组治疗16周后HbAn 1c、血糖、血脂、体重、胰岛素抗体（IAA）等较基线的变化以及不良事件发生情况。组间比较采用n t检验、n t′检验、χ2检验或Fisher确切率检验，组内比较采用配对n t检验。n 结果:治疗16周后试验组和对照组HbAn 1c自基线分别下降（1.18±1.26）%和（1.41±1.30）%，协方差分析显示试验组非劣效于对照组（n F=2.81，n P>0.05），单侧97.5%可信区间为-0.14（-0.30，∞）。治疗16周后空腹血糖及餐后2 h血糖自基线下降绝对值两组间差异均无统计学意义（n P>0.05）。治疗16周后甘油三酯、总胆固醇、低密度脂蛋白胆固醇及高密度脂蛋白胆固醇较基线变化情况两组间差异均无统计学意义（n P>0.05）。治疗16周后体重及IAA自基线变化情况两组间差异均无统计学意义（n P>0.05）。两组间全部不良事件、与研究药物有关的不良事件、严重不良事件以及低血糖事件发生率差异均无统计学意义（n P>0.05）。n 结论:国产重组赖脯胰岛素在降糖疗效方面非劣效于进口赖脯胰岛素，在血脂变化、体重增加、胰岛素抗体发生及安全性方面与进口赖脯胰岛素相当。“,”Objective:To evaluate the efficacy and safety of recombinant insulin lispro (produced by Jiangsu Wanbang Biopharmaceuticals) in the patients with diabetes mellitus.Methods:A multi-center (29 hospitals), randomized, and positive parallel controlled clinical trial was carried out from November 2017 to November 2019. Six hundred and twenty six patients with diabetes duration longer than 6 months, only oral antidiabetics (OAD) therapy or OAD combined with insulin therapy or only insulin therapy (≥twice per day) stabilized for more than 3 months, 7.5%≤ hemoglobin A1c (HbAn 1c) ≤13.0% were selected and randomly assigned to observation group (n n=315) and control group (n n=311) according to the ratio of 1∶1 (block randomization). The two groups were given recombinant insulin lispro (observation group, n n=315) or insulin lispro (control group, n n=310, 1 case was rejected) injection once before each meal, both on the basis of injection of recombinant insulin glargine once daily. The change in HbAn 1c, blood glucose, lipid levels, body weight, insulin autoantibody (IAA) and incidence of adverse events after 16 weeks was compared. The n t test, n t′ test, chi-square test or Fisher exact probability test were used for comparison between groups and paired n t test was used for intra-group comparison.n Results:After 16-week of treatment, HbA1c reduced (1.18±1.26)% and (1.41±1.30)% from baseline respectively in observation group and control group, with non-inferiority found in observation group as compared with control group using analysis of variance (ANOVA) model (n F=2.81, n P>0.05, one-side 97.5%CI: -0.14(-0.30, ∞). There was no statistically significant difference in reduction of FPG and 2hPG from baseline to the 16th week between two groups (n P>0.05). There was no statistically significant differences in change of triglyceride, total cholesterol, low density lipoprotein cholesterol and high density lipoprotein cholesterol levels from baseline to the 16th week between two groups (n P>0.05). There was no statistically significant differences in change of body weight and IAA from baseline to the 16th week between two groups (n P>0.05). There was no statistically significant differences in the rate of hypoglycemia events or other adverse events between two groups (n P>0.05).n Conclusions:The domestic recombinant insulin lispro is non-inferiorto imported insulin lispro in the terms of efficacy. The safety and changes of lipid level, body weight, IAA of domestic recombinant insulin lispro are consistent with imported insulin lispro.