既往接受基础胰岛素治疗的中国2型糖尿病患者转为接受门冬胰岛素30治疗24周后的安全性和疗效:A_1chieve研究亚组分析

Improving glycemic control with biphasic insulin aspart 30in Chinese patients with type 2 diabetes inadequately controlled with basal insulin and oral glucose-lowering drugs:A subgroup analysis from the A_1 chieve study

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2hPG。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。研究对象所有重度、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9.2mmol/L降至6.9mmol/L(下降值为-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0.4kg(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后安全性及耐受性良好,血糖控制显著改善。

Objective To evaluate clinical safety and effectiveness of biphasic insulin aspart（BIAsp 30） in Chinese T2DM patients in poor blood glucose control treated with basal insulin previously. Methods The A1 chieve 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 HbAlc, average FPG and 2 hPG. This subgroup analysis consisted of Chinese T2DM patients to analyze, who received basic insulin treatment before entering the study and accepted biphasic insulin aspart 30 treatment in the study. Results Glycemic improvements were shown by HbA1 c（mean 9.0% to 7.1%, reduction --1.9%）, fasting plasma glucose（mean 9.2 mrnol/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.