Kesavadev Jothydev
Department of Internal Medicine, Jothydev's Diabetes Research, Trivandrum, Kerala, India.
Indian J Endocrinol Metab. 2013 Nov;17(Suppl 2):S565-8. doi: 10.4103/2230-8210.122138.
The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents.
Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Trivandrum, India.
A total of 528 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Patients had started on or were switched to biphasic insulin aspart (n = 392), insulin detemir (n = 65), insulin aspart (n = 70) and other insulin combinations (n = 1). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.9%) and insulin user (mean HbA1c: 8.1%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA1c (insulin naïve: -2.4%, insulin users: -1.0%). SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients.
Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.
A1chieve研究是一项多中心(28个国家)、为期24周的非干预性研究,评估了地特胰岛素、双相门冬胰岛素和门冬胰岛素在四大洲接受常规临床护理的2型糖尿病患者(n = 66,726)中的安全性和有效性。
在基线、12周和24周时收集数据。本简短通讯展示了来自印度特里凡得琅的入组患者的结果。
共有528名患者入组该研究。研究中使用了四种不同的胰岛素类似物治疗方案。患者开始使用或转换为双相门冬胰岛素(n = 392)、地特胰岛素(n = 65)、门冬胰岛素(n = 70)和其他胰岛素组合(n = 1)。在基线时,初治胰岛素患者(平均糖化血红蛋白:9.9%)和使用胰岛素患者(平均糖化血红蛋白:8.1%)的血糖控制均较差。治疗24周后,两个研究组的糖化血红蛋白均有所改善(初治胰岛素患者:-2.4%,使用胰岛素患者:-1.0%)。任何研究患者均未发生包括严重低血糖事件或发作在内的严重不良药物反应。
开始使用或转换为胰岛素类似物与血糖控制改善及低血糖发生率低相关。