Kesavadev Jothydev, Joshi Shashank R
Jothydev's Diabetes Research Centre, Trivandrum 695032, Kerala.
Department of Endocrinology, Lilavati Hospital, Mumbai.
J Assoc Physicians India. 2013 Jan;61(1 Suppl):28-30.
The A1chieve study evaluated safety and effectiveness of insulin analogues in a large and diverse population. This report presents a subgroup analysis of the A1chieve observational study pertaining to India.
To assess safety and effectiveness of initiation or intensification of insulin detemir in patients with type 2 diabetes mellitus (T2DM) not achieving adequate glycemic control.
The A1chieve study was a prospective, multi-center, open-label, non-interventional study of 24-weeks duration. In this post-hoc analysis, Indian patients with T2DM who did not achieve their glycemic targets, and were started with or switched to insulin detemir, were evaluated at baseline and after 24 weeks of therapy for safety and effectiveness. Adverse events (AE) noted during the course of therapy were recorded. Additionally Glycemic, non-glycemic parameters and quality of life indices were reported. Appropriate statistical analysis was carried out to assess the statistical significance.
The Indian cohort of 2707 patients with T2DM treated with insulin detemir included 2336 (86.29%) insulin-naive and 371 (13.71%) insulin-experienced patients. No adverse drug reaction (ADR) was noted over 24 weeks, one patient (out of 2707) reported serious adverse event. Major hypoglycemia was reported in 0.5% (0.08 events/patient year) patients and reduced to 0% (0 events/patient year) over 24 weeks. After 24 weeks' treatment with insulin detemir, an overall reduction in HbA(1c) of 2.1% was noted (p < 0.001), with a 2.1% (p < 0.001) and 2% (p < 0.001) reduction in insulin-naive and insulin-experienced groups, respectively. A significant reduction in fasting ([mean +/- SD] -3.8 +/- 2.5 mmol/L) and postprandial (-5.2 +/- 3.9 mmol/L) blood glucose (FPG and PPG) was also observed (p < 0.001 for both). At end of the study, 24.4% patients achieved the ADA target of < 7.0% and 14.3% patients achieved the AACE target of < 6.5% for HbA(1c). A significant improvement in quality of life indices like ED-5D (0.31 +/- 0.29; p < 0.001) and EQ-VAS (21.7 +/- 16.7; p < 0.001) was noticed.
In patients with T2DM not achieving their glycemic targets addition of basal insulin detemir was well tolerated and reported improvement in glycemic control.
A1chieve研究评估了胰岛素类似物在大量不同人群中的安全性和有效性。本报告呈现了A1chieve观察性研究中针对印度人群的亚组分析。
评估在血糖控制不佳的2型糖尿病（T2DM）患者中起始或强化使用地特胰岛素的安全性和有效性。
A1chieve研究是一项为期24周的前瞻性、多中心、开放标签、非干预性研究。在这项事后分析中，对未达到血糖目标且开始使用或换用地特胰岛素的印度T2DM患者，在基线期和治疗24周后进行安全性和有效性评估。记录治疗过程中出现的不良事件（AE）。此外，还报告了血糖、非血糖参数和生活质量指标。进行了适当的统计分析以评估统计学意义。
接受地特胰岛素治疗的2707例印度T2DM患者队列中，2336例（86.29%）为初治胰岛素患者，371例（13.71%）为有胰岛素使用经验的患者。24周内未观察到药物不良反应（ADR），2707例患者中有1例报告了严重不良事件。0.5%（0.08次事件/患者年）的患者报告有严重低血糖，24周后降至0%（0次事件/患者年）。接受地特胰岛素治疗24周后，糖化血红蛋白（HbA1c）总体降低了2.1%（p < 0.001），初治胰岛素组和有胰岛素使用经验组分别降低了2.1%（p < 0.001）和2%（p < 0.001）。空腹血糖（[均值±标准差] -3.8 ± 2.5 mmol/L）和餐后血糖（-5.2 ± 3.9 mmol/L）也有显著降低（两者p均 < 0.001）。在研究结束时，24.4%的患者达到了ADA设定的HbA1c < 7.0%的目标，14.3%的患者达到了AACE设定的HbA1c < 6.5%的目标。生活质量指标如欧洲五维健康量表（ED-5D）（0.31 ± 0.29；p < 0.001）和视觉模拟量表（EQ-VAS）（21.7 ± 16.7；p < 0.001）有显著改善。
在血糖控制未达目标的T2DM患者中，加用基础胰岛素地特胰岛素耐受性良好，且血糖控制得到改善。
