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从双相或基础人胰岛素转换为门冬胰岛素 30 双相制剂治疗 2 型糖尿病患者的安全性和有效性:A1chieve 研究海湾队列的结果

Safety and efficacy of biphasic insulin aspart 30 in type 2 diabetes patients switched from either biphasic or basal human insulin: results from the Gulf cohort of the A1 chieve study.

作者信息

Almansari A, Khader S, Kharawagh A, AbdelFattah W, Badawy T

机构信息

Dr. Erfan and Bagedo Hospital, Jeddah, Saudi Arabia.

出版信息

Int J Clin Pract. 2014 Jul;68(7):850-6. doi: 10.1111/ijcp.12391. Epub 2014 Feb 18.

DOI:10.1111/ijcp.12391
PMID:24548757
Abstract

AIM

The 24-week, international, non-interventional A1 chieve study aimed to evaluate the safety and efficacy of insulin analogues in type 2 diabetes (T2D) in different countries. This sub-analysis reports results for T2D patients who switched from either biphasic human insulin (BHI) or human neutral protamine Hagedorn (NPH) insulin to biphasic insulin aspart 30 (BIAsp 30) in the Gulf cohort.

METHODS

Gulf patients with T2D who switched to BIAsp 30 from either BHI or NPH insulin were included. Safety and efficacy measurements were made by the physicians as part of routine clinical care.

RESULTS

A total of 1486 patients switched from BHI to BIAsp 30 (BIP group) and 232 patients switched from NPH insulin to BIAsp 30 (NEU group). Baseline glycated haemoglobin A1c (HbA₁c ) was poor in patients in the BIP and NEU groups (mean value ± SD: 9.4 ± 1.8% and 9.7 ± 1.5%, respectively). Significant reductions in the proportion of patients reporting hypoglycaemia (overall, major, minor and nocturnal) were noted in the BIP group after 24 weeks of BIAsp 30 therapy (p < 0.001). No major hypoglycaemic events were reported at Week 24 in the NEU group. In both groups, the mean HbA1c , fasting plasma glucose and postprandial plasma glucose improved significantly after 24 weeks of BIAsp 30 therapy (p < 0.001). The mean body weight, lipid parameters and systolic blood pressure also improved significantly in both groups (p < 0.05).

CONCLUSION

BIAsp 30 therapy enhanced glycaemic control over 24 weeks and was well-tolerated in T2D patients poorly controlled on prestudy BHI or NPH insulin.

摘要

目的

为期24周的国际性、非干预性A1chieve研究旨在评估胰岛素类似物在不同国家2型糖尿病(T2D)患者中的安全性和有效性。本亚组分析报告了海湾队列中从双相人胰岛素(BHI)或人低精蛋白锌胰岛素(NPH)转换为门冬胰岛素30双相制剂(BIAsp 30)的T2D患者的结果。

方法

纳入从BHI或NPH胰岛素转换为BIAsp 30的海湾地区T2D患者。医生在常规临床护理过程中进行安全性和有效性测量。

结果

共有1486例患者从BHI转换为BIAsp 30(BIP组),232例患者从NPH胰岛素转换为BIAsp 30(NEU组)。BIP组和NEU组患者的基线糖化血红蛋白A1c(HbA₁c)水平较差(平均值±标准差:分别为9.4±1.8%和9.7±1.5%)。BIAsp 30治疗24周后,BIP组报告低血糖(总体、严重、轻微和夜间)的患者比例显著降低(p<0.001)。NEU组在第24周未报告严重低血糖事件。在两组中,BIAsp 30治疗24周后,平均HbA1c、空腹血糖和餐后血糖均显著改善(p<0.001)。两组的平均体重、血脂参数和收缩压也显著改善(p<0.05)。

结论

BIAsp 30治疗在24周内增强了血糖控制,并且在研究前使用BHI或NPH胰岛素控制不佳的T2D患者中耐受性良好。

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