·糖尿病胰岛素治疗·

　　【摘要】 目的 研究使用基础胰岛素血糖控制不佳的中国T2DM患者，转为接受门冬胰岛素30治疗的安全性及有效性。方法 A1chieve是1项为期24周的国际多中心、前瞻性、开放标签及非干预性的有关胰岛素类似物的研究。安全性指标为低血糖事件和药物不良反应的发生情况。主要疗效指标包括HbA1c、平均FPG和PPG。本亚组分析选取进入研究前接受基础胰岛素治疗，在亚组分析中接受门冬胰岛素30治疗的中国T2DM患者进行分析。 结果 本亚组分析包括T2DM患者238例。研究对象重度、夜间低血糖事件发生率(次/患者.年)基线时分别为3.61%、0.27%及0.60%;24周时分别为2.02%、0.00%及0.52%。治疗24周后平均HbA1c由9.0%降至7.1%(下降值为-1.9%，P<0.05);平均FPG由9.2 mmol/L降至6.9 mmol/L(下降值-2.3 mmol/L，P<0.05);总体HbA1c达标率(<7.0%)由15.3%升至46.0%;平均体重增加0.4 kg(P<0.05)。结论 对于使用基础胰岛素治疗血糖控制不佳的中国T2DM患者，使用门冬胰岛素30后安全性耐受性良好，血糖控制显著改善。

　　【关键词】门冬胰岛素30;基础胰岛素;口服降糖药物

Improving glycemic control with biphasic insulin aspart 30 in Chinese patients with type 2 diabetes inadequately controlled with basal insulin and oral glucose-lowering drugs: A subgroup analysis from the A1chieve study SHI Yong-quan, LEI Min-xiang, CHEN Li-ming, et al.Department of Endocrinology, Shanghai Changzheng Hospital， Shanghai 200003， China

Corresponding Author: Yang Wenying, Email：ywying_1010@163.com

　　【Abstract】Objective To evaluate clinical safety and effectiveness of biphasic insulin aspart (BIAsp 30) in Chinese T2DM patients in poor blood glucose control treated with oral glucose-lowering drugs (OGLDs) previously. Methods The A1chieve study was international,prospective, open-label,24 weeks study in patients with type 2 diabetes initiating insulin analogues. Data on hypoglycemia and other drug adverse events reactions were collected at baseline,week 12 and 24.The main therapeutic indexes included HbA1c, average FPG and 2 hPG. This subgroup analysis selected Chinese T2DM patients to analyze, who received basic insulin treatment before entering the study and accepted biphasic insulin aspart 30 treatment in the subgroup analysis. Results Glycemic improvements were shown by HbA1c(mean 9.0 % to 7.1%,reduction -1.9% ),fasting plasma glucose(mean 9.2 mmol/L to 6.9 mmol/L, reduction -2.3 mmol/L), all　P<0.01.Rates of total,severe, nocturnal hypoglycemic events (events/ patient/year)were 3.61%, 0.27% and 0.60% respectively at baseline and 2.02%, 0.00% and 0.52% at 24 weeks. The average weight gain was 0.4 kg(P<0.05)Conclusion Biphasic insulin aspart (BIAsp 30)treatment of Chinese T2DM patients improves blood glucose control with low risk of hypoglycemia.

　　【Key words】 Biphasic insulin aspart 30;Basal insulin; Oral glucose-lowering drugs