Internal Medicine Department, EHU Oran, Algeria.
Diabetes Res Clin Pract. 2013 Aug;101 Suppl 1:S4-14. doi: 10.1016/S0168-8227(13)70014-7.
To evaluate the safety and effectiveness of insulin analogues in patients with type 2 diabetes (T2D) from Morocco, Algeria and Tunisia that formed the Maghrebian cohort of the 24-week, non-interventional A₁chieve study.
Patients starting biphasic insulin aspart, insulin detemir and insulin aspart, alone or in combination, were included. The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events. Secondary outcomes 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 evaluated using the EQ-5D questionnaire.
Overall, 3720 patients with a mean age of 58.6 years, body mass index of 27.7 kg/m(2) and diabetes duration of 11.5 years were enrolled. Pre-study, insulin-experienced patients had a mean ± SD dose of 0.54 ± 0.27 U/kg. In the entire cohort, the mean dose was 0.42 ± 0.27 U/kg at baseline, titrated to 0.55 ± 0.30 U/kg by Week 24. Twenty-six SADRs were reported during the study. There was a significant decrease in the proportion of patients reporting overall hypoglycaemia from baseline to Week 24 (18.3% to 13.8%, p < 0.0001). The mean HbA₁c improved significantly from 9.5 ± 1.8% to 7.9 ± 1.4% (p < 0.001). The mean FPG, PPPG, SBP, total cholesterol and QoL also improved significantly (all p < 0.001), while the mean body weight increased by 0.9 ± 3.9 kg (p < 0.001).
Insulin analogue therapy was well-tolerated and was associated with improved glycaemic control.
评估来自摩洛哥、阿尔及利亚和突尼斯的 2 型糖尿病（T2D）患者使用胰岛素类似物的安全性和有效性，这些患者构成了 24 周、非干预性 A₁chieve 研究的马格里布队列。
纳入开始使用双相门冬胰岛素、地特胰岛素和门冬胰岛素的患者，单独或联合使用。主要结局是严重药物不良反应（SADR）的发生率，包括严重低血糖事件。次要结局包括低血糖、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。使用 EQ-5D 问卷评估生活质量（QoL）。
总体而言，纳入了 3720 名平均年龄为 58.6 岁、体重指数为 27.7kg/m²和糖尿病病程为 11.5 年的患者。在研究前，有胰岛素治疗经验的患者平均（±SD）剂量为 0.54±0.27U/kg。在整个队列中，基线时平均剂量为 0.42±0.27U/kg，到第 24 周时调整为 0.55±0.30U/kg。研究期间报告了 26 例 SADR。与基线相比，报告总体低血糖的患者比例从第 18.3%显著下降到第 24 周的 13.8%（p＜0.0001）。HbA₁c 从 9.5±1.8%显著改善至 7.9±1.4%（p＜0.001）。FPG、PPPG、SBP、总胆固醇和 QoL 也显著改善（均 p＜0.001），而平均体重增加了 0.9±3.9kg（p＜0.001）。
胰岛素类似物治疗耐受良好，与改善血糖控制相关。
