长舒霖®和来得时®治疗2型糖尿病的有效性和安全性比较:多中心、随机、开放、平行、Ⅲ期临床研究  

Efficacy and safety of Changsulin®compared with Lantus®in type 2 diabetes:a phaseⅢmulticenter,randomized,open-label,parallel,controlled clinical trial

作　　者：张婷婷[1] 刘晓民[2] 施秉银[3] 王长江[4] 莫朝晖[5] 刘煜[6] 单忠艳[7] 杨文英[8] 李全民 吕肖峰 杨金奎[11] 薛耀明[12] 朱大龙[13] 石勇铨 黄勤 周智广[16] 王清[17] 姬秋和 李延兵[19] 高鑫 陆菊明[21] 张俊清[1] 郭晓蕙[1] Zhang Tingting;Liu Xiaomin;Shi Bingyin;Wang Changjiang;Mo Zhaohui;Liu Yu;Shan Zhongyan;Yang Wenying;Li Quanmin;Lyu Xiaofeng;Yang Jinkui;Xue Yaoming;Zhu Dalong;Shi Yongquan;Huang Qin;Zhou Zhiguang;Wang Qing;Ji Qiuhe;Li Yanbing;Gao Xin;Lu Juming;Zhang Junqing;Guo Xiaohui(Department of Endocrinology,Peking University First Hospital,Beijing 100034,China;Department of Endocrinology,The First Affiliated Hospital of Harbin Medical University,Harbin 150001,China;Department of Endocrinology,The First Affiliated Hospital of Xi′an Jiao Tong University,Xi′an 710061,China;Department of Endocrinology,The First Affiliated Hospital of Anhui Medical University,Hefei 230022,China;Department of Endocrinology,The Third Xiangya Hospital of Central South University,Changsha 410013,China;Department of Endocrinology,The Second Hospital of Jilin University,Changchun 130041,China;Department of Endocrinology,The First Affiliated Hospital of China Medical University,Shenyang 110001,China;Department of Endocrinology,China-Japan Friendship Hospital,Beijing 100029,China;Department of Endocrinology,PLA Rocket Force General Hospital,Beijing 100088,China;Department of Endocrinology,PLA Army General Hospital,Beijing 100700,China;Department of Endocrinology,Beijing Tongren Hospital,Capital Medical University,Beijing 100730,China;Department of Endocrinology,Nanfang Hospital of Nanfang Medical University,Guangzhou 510515,China;Department of Endocrinology,Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China;Department of Endocrinology,Shanghai Changzheng Hospital,Shanghai 200003,China;Department of Endocrinology,Shanghai Changhai Hospital,Shanghai 200433,China;Department of Endocrinology,The Second Xiangya Hospital of Central South University,Changsha 410011,China;Department of Endocrinology,Xijing Hospital,Fourth Military Medical University,Xi′an 710032,China;Department of Endocrinology,The First Affiliated Hospital of Sun Yat-sen University,Guangzhou 510080,China;Department of Endocrinol

机构地区：[1]北京大学第一医院内分泌科,100034 [2]哈尔滨医科大学附属第一医院内分泌科,150001 [3]西安交通大学第一附属医院内分泌科,710061 [4]安徽医科大学第一附属医院内分泌科,合肥230022 [5]中南大学湘雅三医院内分泌科,长沙410013 [6]吉林大学第二医院内分泌科,长春130041 [7]中国医科大学附属第一医院内分泌科,沈阳110001 [8]中日友好医院内分泌科,北京100029 [9]解放军火箭军总医院内分泌科,北京100088 [10]解放军陆军总医院内分泌科,北京100700 [11]首都医科大学附属北京同仁医院内分泌科,100730 [12]南方医科大学南方医院内分泌科,广州510515 [13]南京大学医学院附属鼓楼医院内分泌科,210008 [14]海军军医大学第二附属医院(上海长征医院)内分泌科,上海200003 [15]海军军医大学第一附属医院(上海长海医院)内分泌科,上海200433 [16]中南大学湘雅二医院内分泌科,长沙410011 [17]吉林大学中日联谊医院内分泌科,长春130033 [18]空军军医大学第一附属医院(第四军医大学西京医院)内分泌科,西安710032 [19]中山大学附属第一医院内分泌科,广州510080 [20]复旦大学附属中山医院内分泌科,上海200032 [21]解放军总医院第一医学中心内分泌科,北京100853

出　　处：《中华内科杂志》2020年第12期960-967,共8页Chinese Journal of Internal Medicine

摘　　要：目的:比较长舒霖®和来得时®治疗2型糖尿病的有效性和安全性。方法:多中心、随机、开放、平行组、阳性药物对照、Ⅲ期临床研究,入选578例口服降糖药血糖控制不佳的2型糖尿病患者,按区组分段随机方法将受试者按3∶1的比例随机进入长舒霖®组和来得时®组,治疗24周。比较两组治疗前后糖化血红蛋白(HbA1c)、空腹血糖(FPG)、标准餐后2h血糖(2hPG)、8点指尖血糖谱、结束时HbA1c和FPG达标率以及低血糖事件、不良事件的发生率和甘精胰岛素特异性抗体阳性率。结果:治疗24周后长舒霖®组与来得时®组的HbA1c分别下降1.16%和1.25%,FPG分别下降3.05 mmol/L和2.90 mmol/L,2hPG分别下降2.49 mmol/L和2.38 mmol/L,上述指标两组比较差异无统计学意义(P值均0.05)。两组治疗前后8点指尖血糖谱以及结束时HbA1c和FPG达标率相似(P值均0.05)。长舒霖®组与来得时®组总体低血糖发生率(38.00%和39.01%)和夜间低血糖发生率(17.25%和16.31%)差异均无统计学意义(P值均0.05),大部分为无症状性低血糖,两组均无重度低血糖。两组不良事件发生率(61.77%比52.48%)和甘精胰岛素特异性抗体阳性率(24周时6.91%比3.65%)差异无统计学意义(P值均0.05)。结论:长舒霖®治疗2型糖尿病的有效性和安全性与来得时®相当,并具有良好的耐受性。Objective To compare the efficacy and safety of Changsulin®with Lantus®in treating patients with type 2 diabetes mellitus(T2DM).Methods This was a phaseⅢ,multicenter,randomized,open-label,parallel-group,active-controlled clinical trial.A total of 578 participants with T2DM inadequately controlled on oral hypoglycemic agents were randomized 3∶1 to Changsulin®or Lantus®treatment for 24 weeks.The efficacy measures included changes in glycosylated hemoglobin(HbA1c),fasting plasma glucose(FPG),2h postprandial plasma glucose(2hPG),8-point self-monitoring of blood glucose(SMBG)profiles from baseline,and proportions of subjects achieving targets of HbA1c and FPG.The safety outcomes included rates of hypoglycemia,adverse events(AEs)and anti-insulin glargine antibody.Results After 24 weeks of treatment,mean HbAlc decreased 1.16%and 1.25%,FPG decreased 3.05 mmol/L and 2.90 mmol/L,2hPG decreased 2.49 mmol/L and 2.38 mmol/L in Changsulin®and in Lantus®,respectively.No significant differences could be viewed in above parameters between the two groups(all P>0.05).There were also no significant differences between Changsulin®and Lantus®in 8-point SMBG profiles from baseline and proportions of subjects achieving the targets of HbA1c and FPG(all P>0.05).The rates of total hypoglycemia(38.00%and 39.01%for Changsulin®and Lantus®,respectively)and nocturnal hypoglycemia(17.25%and 16.31%for Changsulin®and Lantus®,respectively)were similar between the two groups(all P>0.05).Most of the hypoglycemia events were asymptomatic,and no severe hypoglycemia were found in both groups.No differences were observed in rates of AEs(61.77%vs.52.48%)and anti-insulin glargine antibody(after 24 weeks of treatment,6.91%vs.3.65%)between the two groups(all P>0.05).Conclusions Changsulin®shows similar efficacy and safety profiles compared with Lantus®and Changsulin®treatment was well tolerated in patients with T2DM.

关 键 词：糖尿病 2型 甘精胰岛素 有效性 安全性 

分 类 号：R587.1[医药卫生—内分泌]