摘要
目的探讨门冬胰岛素30注射液锐舒霖®30和诺和锐®30治疗2型糖尿病的疗效及安全性。方法本研究为多中心、随机、开放、平行、阳性药物对照Ⅲ期临床研究。纳入2018年10月10日至2021年1月5日来自国内35家研究中心口服药治疗血糖控制不佳的2型糖尿病患者,按照3∶1的比例根据区组随机方法分配至锐舒霖®30组和诺和锐®30组。治疗24周后,比较2组受试者治疗前后糖化血红蛋白(HbA1c)、空腹血糖(FPG)、标准餐后2 h静脉血糖(2hPG)的变化,以及低血糖事件和不良事件发生率、门冬胰岛素特异性抗体阳性率。有效性指标分析采用全分析集和符合方案集,安全性指标分析采用安全性数据集。组内比较采用配对t检验,组间比较采用独立样本t检验、χ2检验或Wilcoxon秩和检验。结果本研究共纳入受试者588例,完全符合方案病例528例(锐舒霖®30组395例,诺和锐®30组133例),全分析集和安全性数据集583例(锐舒霖®30组439例,诺和锐®30组144例),符合方案集515例(锐舒霖®30组386例,诺和锐®30组129例)。经过24周治疗后,锐舒霖®30组和诺和锐®30组的HbA1c分别下降1.73%±1.27%和1.77%±1.40%,FPG分别下降(2.34±2.69)和(2.68±2.84)mmol/L,2hPG分别下降(4.37±4.59)和(4.81±4.43)mmol/L,差异均无统计学意义(P>0.05)。治疗24周时,锐舒霖®30组和诺和锐®30组低血糖事件的发生率[分别为74.3%(326/439)和68.1%(98/144)]、不良事件发生率[分别为68.1%(299/439)和66.7%(96/144)]与门冬胰岛素特异性抗体阳性率[分别为51.9%(228/439)和50.7%(73/144)]相近,差异均无统计学意义(P>0.05)。结论锐舒霖®30和诺和锐®30控制血糖的总体疗效相当,具有良好的安全性,在临床上有应用价值。
Objective To explore the efficacy and safety of biphasic insulin aspart 30(Ruisulin®30 and NovoMix®30)in treatment of patients with type 2 diabetes mellitus.Methods This was a multicenter,randomized,open-labeled,parallel,positive drug-controlled phaseⅢclinical trial.This trial included the 588 T2DM patients having poor glucose control after using oral hypoglycemic drugs.All patients were treated with Ruisulin®30 or NovoMix®30 for 24 weeks in both groups by a ratio of 3∶1 according to block random method.The decreased value and qualification rates of glycosylated hemoglobin A1c(HbA1c),fasting blood glucose(FPG),2-hour standard postprandial venous plasma glucose(2hPG),the incidence of hypoglycemic and adverse events,and the positive rate of aspartic islet specific antibody were compared at the end of 24 weeks.The full analysis set and per-protocol dataset were used for the effectiveness index analysis,and the safety set was used for the security index analysis.Analysis of matched samples t-test,t-test,χ2 test and Wilcoxon test were used.Results The trial included all 588 cases,and 528 of them were completely in accordance with the design plan(395 cases received Ruisulin®30 therapy and 133 cases received NovoMix®30 therapy).There were 583 cases in full analysis set and safety data set(439 cases received Ruisulin®30 therapy and 144 cases received NovoMix®30 therapy),and 515 cases met per-protocol dataset(386 cases received Ruisulin®30 therapy and 129 cases received NovoMix®30 therapy).At the end of 24-week treatment period,HbA1c in Ruisulin®30 group and NovoMix®30 group decreased by(1.73±1.27)%and(1.77±1.40)%,FPG decreased by(2.34±2.69)and(2.68±2.84)mmol/L,and 2hPG decreased by(4.37±4.59)and(4.81±4.43)mmol/L,respectively.There was no statistically significant differences in above parameters between the two groups(all P>0.05).After 24 weeks of treatment,the incidence of hypoglycemic events was 74.3%(326/439)and 68.1%(98/144)in Ruisulin®30 group and NovoMix®30 group,respectively.The incidence of adverse events[68.1%(299/439)and 66.7%(96/144),respectively]was similar to the rate of anti-insulin Aspart antibody positivity[51.9%(228/439)and 50.7%(73/144),respectively],and none of the differences were statistically significant(all P>0.05).Conclusion Ruisulin®30 has good safety,and provides similar glycemic control profiles to NovoMix®30,indicating that Ruisulin®30 has clinical application value.
作者
王维敏
李玲
张秀珍
单忠艳
王桂侠
张力辉
马建华
李冬梅
杨静
李兴
杨金奎
王长江
冉兴无
薛耀明
杨艳兰
李全民
蔡韩青
闫朝丽
朱大龙
Weimin Wang;Ling Li;Xiuzhen Zhang;Zhongyan Shan;Guixia Wang;Lihui Zhang;Jianhua Ma;Dongmei Li;Jing Yang;Xing Li;Jinkui Yang;Changjiang Wang;Xingwu Ran;Yaoming Xue;Yanlan Yang;Quanmin Li;Hanqing Cai;Zhaoli Yan;Dalong Zhu(Department of Endocrinology,Drum Tower Hospital Affiliated to Nanjing University Medical Sohool,Nanjing 210008,China;Department of Endocrinology,Shengjing Hospital of China Medical University,Shenyang 110004,China;Department of Endocrinology,Tongji Hospital of Tongji University,Shanghai 200065,China;Department of Endocrinology,the First Hospital of China Medical University,Shenyang 110001,China;Department of Endocrinology,the First Hospital of Jilin University,Changchun 130061,China;Department of Endocrinology,the Second Hospital of Hebei Medical University,Shijiazhuang 050000,China;Department of Endocrinology,Nanjing First Hospital,Nanjing 210012,China;Department of Endocrinology,Inner Mongolia Autonomous Region People′s Hospital,Hohhot 737399,China;Department of Endocrinology,First Hospital of Shanxi Medical University,Taiyuan 030001,China;Department of Endocrinology,Second Hospital of Shanxi Medical University,Taiyuan 030001,China;Department of Endocrinology,Beijing Tongren Hospital,Capital Medical University,Beijing 100005,China;Department of Endocrinology,the First Affiliated Hospital of Anhui Medical University,Hefei 230022,China;Department of Endocrinology,West China Hospital of Sichuan University,Chengdu 610044,China;Department of Endocrinology,Nanfang Hospital,Southern Medical University,Guangzhou 510515,China;Department of Endocrinology,Shanxi Provincial People′s Hospital,Taiyuan 030012,China;Department of Endocrinology,Plarocket Force General Hospital,Beijing 100088,China;Department of Endocrinology,the Second Hospital of Jilin University,Changchun 130041,China;Department of Endocrinology,the Affiliated Hospital of Inner Mongolia Medical University,Hohhot 750306,China)
出处
《中华糖尿病杂志》
CAS
CSCD
北大核心
2023年第1期32-38,共7页
CHINESE JOURNAL OF DIABETES MELLITUS
作者简介
通信作者:朱大龙,Email:zhudalong@nju.edu.cn。
