Diabetes, Endocrinology and Nutrition Department, Ibn Sina Hospital, Mohammed V Souissi University, Rabat, Morocco.
Diabetes Res Clin Pract. 2013 Aug;101 Suppl 1:S27-36. doi: 10.1016/S0168-8227(13)70016-0.
To determine the safety and effectiveness of insulin analogues in the Moroccan cohort of the prospective, multinational, non-interventional, 24-week A₁chieve study.
Moroccan patients with type 2 diabetes (T2D) starting biphasic insulin aspart 30, insulin detemir, and insulin aspart alone or in combination were included. The primary outcome was the evaluation of serious adverse drug reactions including major hypoglycaemic events. Secondary outcomes were changes in hypoglycaemic events, glycaemic parameters (HbA1c, fasting plasma glucose [FPG], postprandial plasma glucose [PPPG]), systolic blood pressure (SBP), body weight and lipid profile. Quality of life (QoL) was evaluated using the EQ-5D questionnaire.
In this analysis, 1641 patients (923 insulin-naive, 718 insulin-experienced) having a mean age 57.1 years, mean BMI 26.8 kg/m(2) and mean diabetes duration 10.3 years, were included. Baseline HbA1c in the entire cohort was poor (9.7%, 83 mmol/mol). Insulin analogues statistically significantly improved glucose control (HbA1c, FPG and PPPG, p < 0.001) at Week 24. The rate of hypoglycaemia decreased from 9.31 to 4.71 events/patient-year (change in proportion of patients affected, p = 0.0002). A statistically significant improvement in lipid parameters (except HDL cholesterol) was observed while body weight changed minimally. Additionally, QoL was positively impacted (mean change in visual analogue scores from EQ-5D was 15.8 points, p < 0.001).
Insulin analogue therapy resulted in improved glycaemic control and a significant overall decrease in hypoglycaemia in Moroccan T2D patients.
在前瞻性、多国、非干预性、24 周的 A1chieve 研究中，确定胰岛素类似物在摩洛哥队列中的安全性和有效性。
纳入起始使用门冬胰岛素 30 双时相、地特胰岛素和门冬胰岛素单药或联合治疗的 2 型糖尿病（T2D）摩洛哥患者。主要结局是评估严重药物不良反应，包括严重低血糖事件。次要结局是低血糖事件、血糖参数（HbA1c、空腹血糖[FPG]、餐后血糖[PPPG]）、收缩压（SBP）、体重和血脂谱的变化。使用 EQ-5D 问卷评估生活质量（QoL）。
在这项分析中，纳入了 1641 例患者（923 例胰岛素初治，718 例胰岛素经治），平均年龄 57.1 岁，平均 BMI 26.8 kg/m²，平均糖尿病病程 10.3 年。整个队列的基线 HbA1c 较差（9.7%，83mmol/mol）。胰岛素类似物在 24 周时显著改善了血糖控制（HbA1c、FPG 和 PPPG，p＜0.001）。低血糖事件发生率从 9.31 降至 4.71 例/患者-年（受影响患者比例的变化，p=0.0002）。观察到血脂参数（除高密度脂蛋白胆固醇外）显著改善，而体重变化极小。此外，QoL 受到积极影响（EQ-5D 视觉模拟评分的平均变化为 15.8 分，p＜0.001）。
胰岛素类似物治疗可改善摩洛哥 T2D 患者的血糖控制，并显著降低总体低血糖风险。
