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甘精胰岛素 U300 与德谷胰岛素 U100 对初诊 2 型糖尿病患者血糖变异性、动脉僵硬度和血脂谱影响的差异:一项交叉开放标签随机试验的结果。

The differences between insulin glargine U300 and insulin degludec U100 in impact on the glycaemic variability, arterial stiffness and the lipid profiles in insulin naïve patients suffering from type two diabetes mellitus - outcomes from cross-over open-label randomized trial.

机构信息

Department of Gastroenterology, University Hospital Split, Spinčićeva 1, 21000, Split, Croatia.

Department of Endocrinology, University Hospital Split, Šoltanska 1, 21000, Split, Croatia.

出版信息

BMC Endocr Disord. 2021 Apr 29;21(1):86. doi: 10.1186/s12902-021-00746-1.

DOI:10.1186/s12902-021-00746-1
PMID:33926446
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8082786/
Abstract

BACKGROUND AND AIMS

Diabetes mellitus type two is one of the major cardiovascular risk factors. Treatment of diabetes can reduce this risk, but the treatment options differ a lot in their risk-reducing capabilities. We compared the impact of insulin degludec (IDeg-100) and insulin glargine U300 (IGlar-300) on cardiovascular risk parameters - glycaemic variability (GV), arterial stiffness and lipid parameters - in insulin naive patients with DMT2.

METHODS

To 23 individuals who previously had uncontrolled DMT2 on two or more oral antidiabetic drugs, IGlar-300 and IDeg-100 were applied for 12 weeks and then switched in a cross over design manner. Prior and after of each insulin phase, we analysed biochemical parameters,7-point SMBG profile over three days and arterial stiffness which was assessed indirectly by measuring the augmentation index (AIx) on the principles of applanation tonometry.

RESULTS

There were no significant differences between IGlar-300 and IDeg-100 regarding reduction of mean glucose values and coefficient of variation (CV). Both insulins insignificantly reduced AIx for standardised pulse of 75 beats/min and without differences between them. IGlar-300 and IDeg-100 reduced triglycerides and increased HDL with no significant difference between the two insulins. IGlar-300 increased the total cholesterol level and IDeg-100 decreased total cholesterol, but without statistically significant difference. IGlar-300 increased LDL level by 0.508 mmol/L and IDeg-100 decreased LDL by 0.217 mmol/L, with statistically significant difference (p = 0.0215).

CONCLUSIONS

This study did not show significant difference between IGlar-300 and IDeg-100 regarding glycaemic parameters and augmentation index using the same dose of 0.2 IU/kg for both insulins, but it has revealed possible differences in impact on lipid profile.

TRIAL REGISTRATION

Clinicaltrials.gov, NCT04692415 . Retrospectively registered on December 31th 2020.

摘要

背景和目的

2 型糖尿病是主要的心血管危险因素之一。糖尿病的治疗可以降低这种风险,但治疗方案在降低风险的能力上有很大的差异。我们比较了在胰岛素初治的 2 型糖尿病患者中,德谷胰岛素(IDeg-100)和甘精胰岛素 U300(IGlar-300)对血糖变异性(GV)、动脉僵硬和血脂参数等心血管风险参数的影响。

方法

23 名先前使用两种或两种以上口服降糖药治疗但血糖控制不佳的 2 型糖尿病患者,先后接受 IGlar-300 和 IDeg-100 治疗 12 周,然后交叉设计切换。在每个胰岛素阶段前后,我们分析了生化参数、3 天 7 点 SMBG 谱和动脉僵硬,后者通过测量基于平板血压计原理的增强指数(AIx)间接评估。

结果

IGlar-300 和 IDeg-100 在降低平均血糖值和变异系数(CV)方面没有显著差异。两种胰岛素均能显著降低标准化脉率为 75 次/分时的 AIx,且两者之间无差异。IGlar-300 和 IDeg-100 降低甘油三酯,增加高密度脂蛋白,两种胰岛素之间无显著差异。IGlar-300 增加总胆固醇水平,IDeg-100 降低总胆固醇,但无统计学差异。IGlar-300 使 LDL 水平升高 0.508mmol/L,IDeg-100 使 LDL 水平降低 0.217mmol/L,有统计学差异(p=0.0215)。

结论

本研究在使用相同剂量的 0.2IU/kg 两种胰岛素的情况下,发现 IGlar-300 和 IDeg-100 在血糖参数和增强指数方面没有显著差异,但发现它们对血脂谱的影响可能存在差异。

试验注册

Clinicaltrials.gov,NCT04692415。于 2020 年 12 月 31 日回顾性注册。

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