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印尼国际 A₁chieve 研究队列的临床经验:BIAsp 30 结果。

Clinical experience with BIAsp 30: results from the Indonesian cohort of the international A₁chieve study.

机构信息

University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia.

出版信息

Diabetes Res Clin Pract. 2013 Apr;100 Suppl 1:S54-9. doi: 10.1016/S0168-8227(13)70011-1.

DOI:10.1016/S0168-8227(13)70011-1
PMID:23647720
Abstract

AIM

To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Indonesian patients with type 2 diabetes (T2D) as part of the 24-week, international, prospective, non-interventional A₁chieve study.

METHODS

Indonesian patients who started BIAsp 30 were included. Safety and efficacy was measured as part of routine clinical practice at baseline, Week 12 and Week 24.

RESULTS

Overall, 1324 patients having a mean ± SD age, duration of diabetes and body mass index of 55.2 ± 9.9 yrs, 6.8 ± 5.2 yrs and 24.1 ± 3.6 kg/m(2), respectively, were enrolled. 67% of patients were insulin-naive and 33% were prior insulin users. Glycaemic control was poor at baseline. After 24 weeks, significant reductions from baseline were observed in the mean glycated haemoglobin A1c (HbA1c) (-2.6%), fasting plasma glucose (-93.8 mg/dL) and postprandial plasma glucose (-134.8 mg/dL) levels in the entire cohort (p < 0.001). Significant reductions were also seen in insulin-naive patients and prior insulin users. At Week 24, 29.9% of patients in the entire cohort achieved target HbA1c level of <7.0%, while 26.7% and 39.2% achieved this target among insulin-naive patients and prior insulin users, respectively. The proportion of patients reporting overall hypoglycaemia significantly decreased in the entire cohort after 24 weeks of BIAsp 30 therapy. A small significant increase in body weight was noted in the entire cohort, insulin-naive patients and prior insulin users.

CONCLUSION

The current study suggests that BIAsp 30 can be considered as a safe and effective option for initiating as well as intensifying insulin therapy in Indonesian patients with T2D.

摘要

目的

评估双相门冬胰岛素 30(BIAsp 30)在印度尼西亚 2 型糖尿病(T2D)患者中的安全性和有效性,这是 24 周国际性、前瞻性、非干预性 A₁chieve 研究的一部分。

方法

纳入起始应用 BIAsp 30 的印度尼西亚患者。安全性和疗效作为常规临床实践的一部分,在基线、12 周和 24 周进行评估。

结果

总体而言,纳入了 1324 例患者,其平均(±标准差)年龄、糖尿病病程和体重指数分别为 55.2±9.9 岁、6.8±5.2 年和 24.1±3.6kg/m²。67%的患者为胰岛素初治患者,33%为胰岛素既往使用者。基线时血糖控制较差。24 周后,整个队列的平均糖化血红蛋白 A1c(HbA1c)(-2.6%)、空腹血浆葡萄糖(-93.8mg/dL)和餐后血浆葡萄糖(-134.8mg/dL)水平较基线显著下降(均<0.001)。胰岛素初治患者和胰岛素既往使用者也观察到显著降低。24 周时,整个队列中有 29.9%的患者达到了<7.0%的目标 HbA1c 水平,而胰岛素初治患者和胰岛素既往使用者分别有 26.7%和 39.2%达到这一目标。整个队列中报告总体低血糖的患者比例在接受 BIAsp 30 治疗 24 周后显著下降。整个队列、胰岛素初治患者和胰岛素既往使用者的体重均略有显著增加。

结论

本研究表明,BIAsp 30 可作为印度尼西亚 T2D 患者起始胰岛素治疗以及强化胰岛素治疗的安全有效选择。

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