University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia.
Diabetes Res Clin Pract. 2013 Apr;100 Suppl 1:S47-53. doi: 10.1016/S0168-8227(13)70010-X.
To determine the safety and efficacy of insulin detemir in Indonesian patients with type 2 diabetes (T2D) as a sub-analysis of the 24-week, prospective, multinational, non-interventional A₁chieve study.
This study included 477 Indonesian T2D patients starting insulin detemir at the discretion of their physicians. Safety and efficacy was measured in routine clinical practice at baseline, interim (around 12 weeks from baseline) and final (around 24 weeks from baseline) visit.
At baseline the mean age, duration of diabetes and mean BMI were 55.3 ± 8.5 years, 5.9 ± 4.0 years and 24 ± 3.6 kg/m(2), respectively. Of these patients, 78% were insulin-naive and 22% were prior insulin users. Glycaemic control was poor at baseline. After 24 weeks, significant reductions were observed in mean HbA1c (2.2%, p < 0.001), fasting plasma glucose (90.0 mg/dL, p < 0.001) and postprandial plasma glucose (115.4 mg/dL, p < 0.001) levels, in the entire cohort. Similar significant reductions were also seen in insulin-naive patients and prior insulin users. In the entire cohort, 32.5% patients achieved HbA1c levels <7.0% while 32.0% insulin-naive patients and 33.9% prior insulin users achieved this target after 24 weeks. No hypoglycaemic events were reported in the entire cohort. Modest increase in body weight was noted in the insulin-naive group, while mean body weight decreased in prior insulin users after 24 weeks of insulin detemir therapy.
This sub-analysis suggests that insulin detemir can be a safe and effective option for initiating insulin therapy in people with T2D in Indonesia.
作为 24 周前瞻性、多国、非干预性 A₁chieve 研究的亚分析,确定德谷胰岛素在印度尼西亚 2 型糖尿病(T2D)患者中的安全性和疗效。
本研究纳入了 477 例根据医生判断起始德谷胰岛素治疗的印度尼西亚 T2D 患者。在基线、中期(距基线约 12 周)和最终访视(距基线约 24 周)时,在常规临床实践中测量安全性和疗效。
基线时,患者的平均年龄、糖尿病病程和平均 BMI 分别为 55.3 ± 8.5 岁、5.9 ± 4.0 年和 24 ± 3.6kg/m²。其中,78%为胰岛素初治患者,22%为胰岛素既往使用者。基线时血糖控制较差。24 周后,整个队列的平均 HbA1c(2.2%,p < 0.001)、空腹血糖(90.0mg/dL,p < 0.001)和餐后血糖(115.4mg/dL,p < 0.001)水平均显著降低。胰岛素初治患者和胰岛素既往使用者也观察到类似的显著降低。在整个队列中,32.5%的患者达到了 HbA1c 水平 <7.0%,而 32.0%的胰岛素初治患者和 33.9%的胰岛素既往使用者在 24 周后达到了这一目标。整个队列中均未报告低血糖事件。在胰岛素初治组中观察到体重适度增加,而在胰岛素既往使用者中,在接受德谷胰岛素治疗 24 周后,平均体重下降。
本亚分析表明,德谷胰岛素可以成为印度尼西亚 T2D 患者起始胰岛素治疗的一种安全有效的选择。