每日1次双时相门冬胰岛素30与甘精胰岛素治疗2型糖尿病患者的比较——Easymix研究中国亚组结果

Comparison of once-daily biphasic insulin aspart 30 with insulin glargine in type 2 diabetes patients——Easymix study in China

目的 观察比较对于口服降糖药治疗效果不佳的中国T2DM患者,每日1次双时相门冬胰岛素30（BIAsp30）与甘精胰岛素的有效性及安全性. 方法 采用开放、随机、多中心的平行对照法,纳入口服降糖药治疗效果不佳且未长期使用胰岛素的T2DM患者,随机接受每日晚餐前1次BIAsp30或每日睡前1次甘精胰岛素,联合二甲双胍及格列美脲治疗24周后评价有效性及安全性. 结果 BIAsp30组210例,甘精胰岛素组212例.治疗结束时,BIAsp30组和甘精胰岛素组HbA1c分别较基线值下降-0.75％和-0.66％（BIAsp30组一甘精胰岛素组=0.08％,95％ CI：-0.23～0.07）.BIAsp30组晚餐后和睡前血糖水平低于甘精胰岛素组（P＜0.01）,而晚餐前血糖水平则高于甘精胰岛素组（P＜0.01）.BIAsp30组餐后血糖增量均值变化及晚餐后血糖增量的变化优于甘精胰岛素组.两组间低血糖事件和不良反应发生情况差异无统计学意义. 结论 以HbA1c作为有效性指标,每日注射1次BI-Asp30作为中国T2DM患者的胰岛素起始方案不劣于每日注射1次甘精胰岛素,且不增加低血糖事件及发生不良反应的风险.

Objective To compare the efficacy and safety between once-daily administered biphasic insulin aspart 30 （BIAsp 30） and insulin glargine in Chinese subjects with type 2 diabetes inadequately controlled with oral anti-diabetic drugs.Methods This was an open-labelled,randomized,parallel-group,multicentre,treat-to-target trial.Insulin-naive patients with type 2 diabetes who did not achieve glycaemic control with oral antidiabetic drugs were enrolled and were randomized to receive once-daily BIAsp 30 before dinner versus insulin glargine at bedtime,both in combination with metformin and glimepiride.Efficacy and safety were assessed and compared after the 24-week treatment period.Results Subjects were randomized into groups treated with BIAsp 30（n=210） and with insulin glargine（n=212）.A total of 392 subjects completed the trial.Estimated mean reduction in HbA1 c from baseline to end of treatment was 0.75 ％ with BIAsp 30 and 0.66％ with insulin glargine（BIAsp 30-insulin glargine=-0.08％,95％ CI：-0.23 ～0.07）.Mean self-measured plasma glouse levels were gignificantly lower in BIAsp 30 group than in insulin glargine group after dinner and at bedtime（P＜0.01）,but significantly higher in BIAsp 30 group than in insulin glargine group before dinner（P＜0.01）.The change of mean prandial increment and the change of prandial increment at dinner were significantly improved in BIAsp group than in insulin glargine group.No significant differences were observed in hypoglycemic episodes and adverse events.Conclusion The efficacy for initiation with once-daily BIAsp 30 in Chinese patients with type 2 diabetes is not inferior to once-daily insulin glargine,without increased risk for hypoglycemic episodes and adverse events.