【摘要】 目的 比较每日3次注射双时相门冬胰岛素(BIAsp 50-50-30)联合二甲双胍与每日两次注射双时相门冬胰岛素(BIAsp 30-30)联合二甲双胍治疗T2DM患者的疗效和安全性。 方法 进行一项为期16周，多中心、随机、开放、平行分组的治疗达标试验。主要疗效指标为HbA1c的变化，其他指标包括八点血糖谱、HbA1c< 7.0%的受试者百分比、餐后血糖增幅、不良事件和低血糖事件等。 结果 441例预混人胰岛素控制不佳的T2DM患者入组试验。基线HbA1c (8.54±1.11)%。治疗16周后，BIAsp 50-50-30组HbA1c的控制优于BIAsp 30-30组[HbA1c分别下降(1.81±1.09)%和(1.48±1.14)%，差值为–0.27 %，95%CI(–0.43; –0.12)]。BIAsp 50-50-30组HbA1c<7%的受试者比例更高，且午餐后2h及晚餐前血糖水平显著低于BIAsp 30-30组(P<0.001)。两组平均餐后血糖增幅的变化相似。两组低血糖事件发生频率和体重增加无统计学差异。 结论 每日3次注射BIAsp 50-50-30对HbA1c的控制优于每日两次注射BIAsp 30-30，且不增加低血糖风险及体重。

　　【关键词】 糖尿病，2型;预混人胰岛素;双时相门冬胰岛素50;双时相门冬胰岛素30

　　Thrice daily regimen of biphasic insulin aspart (BIAsp 50-50-30) versus twice daily regimen of biphasic insulin aspart 30 (BIAsp 30-30), both in combination with metformin

　　Comparison of their efficacy and safety on T2DM patients

　　GAO Yan，GUO Xiao-hui, ZHOU Zhi-guang, et al. Department of Endocrinology, Peking University First Hospital, Beijing 100034, China

　　【Abstract】Objective To evaluate the efficacy and safety of biphasic insulin aspart (BIAsp) thrice daily (50-50-30) versus twice daily BIAsp 30-30 both in combination with metformin on the T2DM patients. Methods In this 16-week, multicentral, randomized, open-labeled, and parallel-grouped clinical trial, the changes in HbA1c were taken as the main therapeutic indices, and the other indices included glucose spectrum of 8 time points, percentage of subjects achieving HbA1c<7.0%, postprandial glucose increment, adverse events, and hypoglycemic episodes. Results A total of 441 subjects with type 2 diabetes previously on premixed human insulin were randomized. Baseline HbA1c was (8.54±1.11)%. After 16 weeks’ treatment, the decrease of HbA1c in the BIAsp 50-50-30 group was more than that in the BIAsp 30-30 group [(1.81±1.09)% vs (1.48±1.14)%, with a difference of -0.27 %, 95%CI (-0.43; -0.12)], indicating that BIAsp 50-50-30 was superior to BIAsp 30-30. Significantly more subjects achieved HbA1c<7% in the BIAsp 50-50-30 group than in the BIAsp 30-30 group. And the 2hPG after lunch and before dinner were significantly lower in the BIAsp 50-50-30 group than in the BIAsp 30-30 group (P<0.001). Mean postprandial increment was not significantly different between the 2 groups. Weight changes and incidence of hypoglycemic episodes were similar in both groups. Conclusion Both in combination of metformin, BIAsp 50-50-30 is superior to BIAsp 30-30 in HbA1c reduction and without increased hypoglycemic episodes and weight gaining.

　　【Key words】 Diabetes mellitus, type 2; Premixed human insulin; BIAsp 50; BIAsp 30