两种甘精胰岛素治疗糖尿病的疗效及安全性比较：多中心、随机、开放、对照试验

Efficacy and safety of glargine insulin injection Uslen versus Lantus in diabetic patients： a multicenter, randomized, open-labeled controlled trial

目的 评价联邦制药生产的甘精胰岛素注射液（优乐灵）治疗糖尿病患者的有效性及安全性.方法 为多中心、随机、开放阳性药物对照临床试验.2011年12月至2012年10月,纳入口服降糖药或使用短效胰岛素血糖控制不佳的1型或2型糖尿病患者,按照1∶1的比例分配至优乐灵或赛诺菲安万特公司的甘精胰岛素（来得时）组,比较两组受试者治疗16周前后糖化血红蛋白（HbA1c）、空腹血糖（FBG）的变化和达标率及低血糖事件和不良反应的发生率.组内比较采用配对t检验或秩和检验,组间比较采用方差分析或Wilcoxon秩和检验.结果 试验共纳入病例664例,完全符合方案623例（优乐灵组313例、来得时组310例）.治疗16周后,优乐灵组和来得时组HbA1c均较基线值显著下降,分别为（9.2±1.5）％比（7.7±1.2）％（t=18.4,P＜0.001）、（9.3±1.5）％比（7.7±1.1）％（t=18.4,P＜0.001）,两组下降值（1.5％比1.6％,t=0.766,P＞0.05）,两组达标率差异无统计学意义[26.2％（82/313）比21.3％（66/310）,P＞0.05];优乐灵组和来得时组FBG均较基线时显著下降,分别为（10.2±2.1）比（7.2±2.0） mmol/L（t=21.2,P＜0.001）,（10.3±2.3）比（7.4 ±2.3）mmol/L（t=16.4,P＜0.001）,两组下降值（3.0比2.9 mmol/L,t=0.280,P＞0.05）,两组达标率差异无统计学意义[29.1％（91/313）比28.4％（88/310）,P＞0.05].两组的低血糖事件[22.7％（75/330）比22.2％（74/333）,P＞0.05]及其他不良反应发生率[0.3％（1/330）比0.3％（1/333）,P＞0.05]差异均无统计学意义.结论 联邦优乐灵与来得时控制血糖的总体能力相当,均有良好的安全性,因而具有较好的临床应用价值.

Objective To evaluate the efficacy and safety of glargine insulin injection （Uslen） in treatment of diabetic patients.Methods A multicenter,randomized,open-labeled and positive control clinical trial included the patients with type 1 or type 2 diabetes mellitus having poor glucose control after using oral antidiabetic drug or short-acting insulin.All patients were treated with Uslen or Lantus for 16 weeks in two groups by a ratio of 1 ∶ 1.The decreased value and qualification rates of glycated hemoglobin A1 c （HbA1 c） and fasting blood glucose （FBG）,the incidence of hypoglycemic and the adverse events were compared pretreatment at the end of 16 weeks＆#39; treatment.Results All of 664 cases were randomized into two groups and received therapy （1 ∶ 1）.But 623 cases were in complete conformity to design plan,313 cases received Uslen therapy and 310 cases received Lantus therapy.There were no different in age,sex,nation,height and weight between two groups.At the end of 16 weeks＆#39; treatment,according to the perprotocol analysis （PPS）,the decreased values of HbA1c separately （9.2 ± 1.5）% vs （7.7 ± 1.2）% and （9.3±1.5） vs （7.7±1.1）%,FBGseparately （10.2±2.1 vs7.2±2.0） mmol/Land （10.3±2.3 vs 7.4 ± 2.3） mmol/L were all proved significantly in both Uslen group and Lantus group （all P 〈 0.001）.But the changes of HbA1c（1.5% vs 1.6%,F=0.766,P=0.382） and FBG（3.0 vs 2.9 mmol/L,F=0.280,P =0.597） from baseline to endpoint were similar between the treatment groups （P 〉 0.05）.There were no significant difference in the two groups on the qualification rates of HbA1c（26.2% （82/313）vs 21.3% （66/310）,P =0.155） and FBG（29.1% （91/313） vs 28.4% （88/310）,P 〉0.05）.There were no significant difference separately 22.7% （75/330） and 22.0% （74/333） on hypoglycemia incidences,and the other adverse events incidences were similar separately 0.3% （1/330 vs 1/333,P 〉 0.05） in two groups.Conclusion Compared with Lantus,the glargine insulin injection of Uslen has similar effect on lowering blood sugar and good security,which has better clinical value.