【摘要】 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。更多还原

【Abstract】 Objective To evaluate the predictors of achieving HbA₁c<7. 0% and achieving HbA₁c<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 HbA₁c < 7. 0% and achieving HbA₁c < 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 HbA₁c 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 HbA₁c <7. 0% without confirmed hypoglycemia. Baseline HbA₁c 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 HbA₁c<7. 0% and achieving HbA₁c<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 HbA₁c <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 HbA₁c 8%～9% and age<65 years had significantly greater odds in achieving HbA₁c<7. 0% without confirmed hypoglycemia. For patients achieved HbA₁c<7. 0%,FPG decreased more in those allocated to IDeg Asp group.ConclusionUncontrolled with basal insulin and baseline HbA₁c are predictors of achieving HbA₁c <7. 0%in Chinese T2DM patients after switching to insulin IDegAsp or BIAsp30.更多还原