2型糖尿病患者每日两次德谷门冬双胰岛素或双时相门冬胰岛素30治疗的糖化血红蛋白达标预测因子——德谷门冬双胰岛素中国Ⅲ期临床注册研究事后分析

Predictors of achieving HbAc<7.0%in patients with type 2 diabetes mellitus receiving twice-daily insulin degludec/insulin aspart or biphasic insulin aspart 30 after switch from other insulin regimens for not achieving targeted glucose control——a post

目的探讨既往接受Ins治疗血糖不达标的中国成人T2DM患者,转为每日两次(BID)德谷门冬双胰岛素(IDegAsp)或双时相门冬胰岛素30(BIAsp30)治疗26周后,HbA1c(<7.0%)及HbA1c安全达标(<7.0%且无确证性低血糖)的预测因子。方法IDegAsp中国Ⅲ期临床注册研究事后分析,评估基线特征中可作为HbA1c达标和HbA1c安全达标的预测因子,比较两组患者9个时点平均自测血糖较基线的变化,以及不同年龄亚组间的疗效及安全性。结果治疗26周后,543例患者中289例(53.2%)HbA1c达标,201例(38.6%)HbA1c安全达标。基线HbA1c水平与HbA1c达标率(OR 0.49,95%CI 0.37~0.64,P<0.001)及HbA1c安全达标率(OR 0.56,95%CI 0.42~0.74,P<0.001)显著相关;既往基础胰岛素治疗方案与HbA1c达标率(OR 2.01,95%CI 1.19~3.41,P=0.009)及HbA1c安全达标率(OR 2.08,95%CI 1.24~3.51,P=0.006)显著相关。IDegAsp治疗患者的HbA1c安全达标率更高。基线HbA1c 8%~9%的患者IDegAsp治疗后HbA1c达标率及HbA1c安全达标率更高。HbA1c达标患者中,接受IDegAsp治疗的患者FPG较基线下降更多。结论既往基础胰岛素治疗和基线HbA1c是中国成年T2DM患者转换为BIAsp30或IDegAsp BID后,获得良好血糖控制的预测因子。

Objective To evaluate the predictors of achieving HbA_(1)c<7.0%and achieving HbA_(1)c<7.0%without confirmatory hypoglycemia in Chinese adults with type 2 diabetes mellitus(T2DM)who switch from other insulin regimens to insulin degludec/insulin aspart(IDeg Asp)or biphasic insulin aspart 30(BIAsp30)after treatment for 26 weeks.Methods This is a post hoc analysis of phase III clinical study of insulin IDeg Asp.The baseline parameters were included in logistic regression analysis to determine the predictors of achieving HbA_(1)c <7.0%and achieving HbA_(1)c <7.0%without confirmed hypoglycemia.The changes of self-monitored blood glucose(SMBG)were compared between the 2 groups.The efficacy and safety were assessed in patients with different baseline HbA_(1)c and age.Results A total of 543 T2DM patients were included.289 subjects(53.2%)achieved HbA1c<7.0%,and 201 subjects(38.6%)achieved HbA_(1)c<7.0%without confirmed hypoglycemia.Baseline HbA_(1)c level(OR 0.49,95%CI 0.37~0.64,P<0.001)and inadequately controlled with basal insulin(OR 2.01,95%CI 1.19~3.41,P=0.009)were predictors of achieving HbA_(1)c<7.0%and achieving HbA_(1)c <7.0%without confirmed hypoglycemia(OR 0.56,95%CI 0.42~0.74,P<0.001)and(OR 2.08,95%CI 1.24~3.51,P=0.006).Achieving HbA_(1)c <7.0%and achieving HbA1c<7.0%without confirmed hypoglycemia were higher in patients allocated to IDeg Asp group compared with patients in BIAsp30 group.Patient with baseline HbA_(1)c 8%~9%and age<65 years had significantly greater odds in achieving HbA_(1)c <7.0%without confirmed hypoglycemia.For patients achieved HbA_(1)c <7.0%,FPG decreased more in those allocated to IDeg Asp group.ConclusionUncontrolled with basal insulin and baseline HbA_(1)c are predictors of achieving HbA_(1)c <7.0%in Chinese T2DM patients after switching to insulin IDegAsp or BIAsp30.