双时相门冬胰岛素30每日1次对2型糖尿病患者的疗效和安全性

目的 评价2型糖尿病患者每日1次应用双时相门冬胰岛素30治疗的有效性和安全性.方法 本研究为多中心、开放性、自身对照的临床观察性研究.2008年9月至2009年6月选取未接受降糖治疗或既往口服降糖药治疗血糖控制效果欠佳的2型糖尿病患者621例,平均年龄（56±11）岁,平均糖尿病病程（4.4±4.2）年（0～30年）,平均体重指数（25.5±2.9）kg/m2,平均糖化血红蛋白（HbA1c）8.5%±1.2%.使用每日1次双时相门冬胰岛素30,起始剂量和最终剂量分别为（0.16±0.05）U/kg、（0.20±0.07）U/kg.联合口服药治疗12周后评价其有效性和安全性,并探索不同基线因素对于疗效的影响.结果 治疗12周后,HbA1c下降了1.8%±1.1%.HbA1c＜6.5%的患者占30.8%,HbA1c＜7%的患者占65.5%.空腹血糖和餐后血糖均显著下降,8时点血糖平均值下降了（3.8±2.3）mmol/L.分别按基线糖尿病病程、HbA1c、注射时间和体重指数分层的分析结果显示,HbA1c达标率随着糖尿病病程的延长和HbA1c的升高而降低.在双时相门冬胰岛索30治疗中,非重度低血糖事件每年每例患者的发生率为1.83次.仅有1例（0.2%）患者发生1次重度（夜间）低血糖事件.患者治疗后体重较治疗前显著降低（P=0.0053）.结论 在未使用降糖治疗或已用口服降糖药但血糖控制不佳的2型糖尿病患者中,双时相门冬胰岛素30每日1次治疗作为胰岛素起始方案,可安全有效地降低血糖水平,尤其适用于HbA1c水平轻至中度升高,病程相对较短的患者.

Efficacy and safety of once-daily biphasic insulin aspart 30 in insulin-na(i)ve patients with type 2 diabetes

Objective To evaluate the efficacy and safety of biphasic insulin aspart 30(BIAsp 30)in the inadequately controlled Chinese patients with type 2 diabetes.Methods Easy Start Study (ESS) was a multi-centre,open-labeled and self-control observational study.From September 2008 to June 2009,a total of 621 insulin-naive patients (pharmacotherapy-na(i)ve patients or patients exposed to oral antidiabetic drugs only) participated in the study.The efficacy and safety of BIAsp 30 once-daily for 12-week were assessed in these patients. Baseline factors potentially impact treatment efficacy were investigated too.Results Baseline demographic characteristics of the 621 patients were summarized as follows: mean age (56±11) years,mean duration of diabetes (4.4 ±4.2 )years,mean body mass index(BMI) (25.5 ±2.9)kg/m2; baseline glycosylated hemoglobin(HbA1c) 8.5% ± 1.2%.The initial and final doses of BIAsp 30 was (0.16 ± 0.05 )U/kg and (0.20 ± 0.07 )U/kg,respectively.After 12-week of treatment,HbA1c decreased by 1.8% ± 1.1% on average,and 30.8% of patients achieved a HbA1c ＜ 6.5% and 65.5% of patients achieved a HbA1c ＜ 7.0%. The fasting and postprandial plasma glucose improved significantly and the mean value of 8-point plasma glucose decreased by ( 3.8 ± 2.3 ) mmol/L.The percentage of patients achieving HbA 1 c target decreased along with the increase of baseline HbA1 c level andthe duration of diabetes.No difference of glycaemic control was observed between the groups of pre-breakfast and pre-dinner injection.The rate of minor hypoglycaemia was 1.83 events per patient per year.Only one case of major hypoglycaemia (nocturnal) was reported.There was no significant body-weight gain before and after treatment.No adverse event reported as related to study drugs was observed.Conclusion For the insulin naive patients,BIAsp 30 once-daily,as insulin initiation,could improve glycaemic control without compromising safety and convenience,especially for the patients with lower HbA1c level and shorter duration of diabetes.