Universiti Sains Malaysia, 16150 Kubang Kerian, Kota Bharu, Kelantan, Malaysia.
Diabetes Res Clin Pract. 2013 Apr;100 Suppl 1:S17-23. doi: 10.1016/S0168-8227(13)70005-6.
To examine the clinical safety and effectiveness of insulin aspart (IAsp) therapy in type 2 diabetes (T2D) patients from the ASEAN cohort of the international, 24-week, non-interventional A₁chieve study.
T2D patients from Indonesia, Malaysia, Philippines and Singapore, who started IAsp therapy with or without oral glucose-lowering drugs, were included. The primary endpoint was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events. Secondary endpoints included hypoglycaemia, glycated haemoglobin A1c [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPPG], systolic blood pressure [SBP], body weight and lipids. Quality of life (QoL) was assessed using the EQ-5D questionnaire.
Overall, 312 T2D patients (222 insulin-naive and 90 insulin-experienced) with a mean ± SD age of 56.6 ± 11.2 years, BMI of 24.2 ± 3.9 kg/m(2) and diabetes duration of 7.0 ± 5.7 years were included. The mean daily IAsp dose was 0.51 ± 0.31 U/kg at baseline titrated up to 0.60 ± 0.29 U/kg at Week 24. No SADRs or major hypoglycaemic events were reported in the entire subgroup. The proportion of patients who reported overall hypoglycaemia decreased from baseline to Week 24 (7.1% vs. 0.3%, p < 0.0001). The mean HbA1c improved from 9.5 ± 1.6% at baseline to 7.6 ± 1.3% after 24 weeks (p < 0.001). The mean FPG, post-breakfast PPPG and SBP also improved (p < 0.001). Health-related QoL scores increased in the entire subgroup (mean increase: 9.8 ± 14.6 points, p < 0.001).
Starting IAsp therapy was well-tolerated and was associated with significantly improved overall glycaemic control in the ASEAN cohort.
评估在 ASEAN 队列的国际性、24 周、非干预性 A₁chieve 研究中，2 型糖尿病（T2D）患者应用门冬胰岛素（IAsp）治疗的临床安全性和有效性。
纳入起始 IAsp 治疗（联合或不联合口服降糖药）的来自印度尼西亚、马来西亚、菲律宾和新加坡的 T2D 患者。主要终点为严重药物不良反应（SADR）发生率，包括主要低血糖事件。次要终点包括低血糖、糖化血红蛋白 A1c（HbA1c）、空腹血糖（FPG）、餐后血糖（PPPG）、收缩压（SBP）、体重和血脂。采用 EQ-5D 问卷评估生活质量（QoL）。
共有 312 例 T2D 患者（222 例胰岛素初治患者和 90 例胰岛素经治患者）纳入研究，平均（±标准差）年龄 56.6±11.2 岁，体重指数（BMI）24.2±3.9kg/m²，糖尿病病程 7.0±5.7 年。基线时 IAsp 日剂量平均为 0.51±0.31U/kg，在 24 周时滴定至 0.60±0.29U/kg。整个亚组均未报告 SADR 或主要低血糖事件。自基线至 24 周时，报告总体低血糖的患者比例从 7.1%降至 0.3%（p<0.0001）。HbA1c 从基线时的 9.5±1.6%改善至 24 周时的 7.6±1.3%（p<0.001）。FPG、早餐后 PPPG 和 SBP 也得到改善（p<0.001）。整个亚组的健康相关 QoL 评分升高（平均升高：9.8±14.6 分，p<0.001）。
起始 IAsp 治疗具有良好的耐受性，在 ASEAN 队列中可显著改善总体血糖控制。
