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一项比较磺酰脲类格列齐特 MR(缓释)和 DPP-4 抑制剂维格列汀对通过连续血糖监测(CGM)测量的 2 型糖尿病巴西女性的血糖变异性和控制的影响的随机对照试验。

A randomized controlled trial to compare the effects of sulphonylurea gliclazide MR (modified release) and the DPP-4 inhibitor vildagliptin on glycemic variability and control measured by continuous glucose monitoring (CGM) in Brazilian women with type 2 diabetes.

机构信息

Pontifical Catholic University of Parana, Curitiba, Brazil; Curitiba Diabetes Center, Division of Endocrinology, Hospital Nossa Senhora das Graças, Curitiba, Brazil.

Curitiba Diabetes Center, Division of Endocrinology, Hospital Nossa Senhora das Graças, Curitiba, Brazil.

出版信息

Diabetes Res Clin Pract. 2018 May;139:357-365. doi: 10.1016/j.diabres.2018.03.035. Epub 2018 Mar 26.

Abstract

AIMS

This study aims to evaluate whether there is a difference between the effects of vildagliptin and gliclazide MR (modified release) on glycemic variability (GV) in women with type 2 diabetes (T2DM) as evaluated by continuous glucose monitoring (CGM).

METHODS

An open-label, randomized study was conducted in T2DM women on steady-dose metformin monotherapy which were treated with 50 mg vildagliptin twice daily or 60-120 mg of gliclazide MR once daily. CGM and GV indices calculation were performed at baseline and after 24 weeks.

RESULTS

In total, 42 patients (age: 61.9 ± 5.9 years, baseline glycated hemoglobin (HbA1c): 7.3 ± 0.56) were selected and 37 completed the 24-week protocol. Vildagliptin and gliclazide MR reduced GV, as measured by the mean amplitude of glycemic excursions (MAGE, p = 0.007 and 0.034, respectively). The difference between the groups did not reach statistical significance. Vildagliptin also significantly decreased the standard deviation of the mean glucose (SD) and the mean of the daily differences (MODD) (p = 0.007 and 0.030).

CONCLUSIONS

Vildagliptin and gliclazide MR similarly reduced the MAGE in women with T2DM after 24 weeks of treatment. Further studies are required to attest differences between vildagliptin and gliclazide MR regarding glycemic variability.

摘要

目的

本研究旨在通过连续血糖监测(CGM)评估维格列汀与格列齐特 MR(改性释放)对 2 型糖尿病(T2DM)女性患者血糖变异性(GV)的影响是否存在差异。

方法

进行了一项开放性、随机研究,纳入正在接受稳定剂量二甲双胍单药治疗的 T2DM 女性患者,这些患者接受每日两次 50mg 维格列汀或每日一次 60-120mg 格列齐特 MR 治疗。在基线和 24 周后进行 CGM 和 GV 指数计算。

结果

共纳入 42 例患者(年龄:61.9±5.9 岁,基线糖化血红蛋白(HbA1c):7.3±0.56),其中 37 例完成了 24 周的方案。维格列汀和格列齐特 MR 均降低了 GV,这可通过血糖波动幅度的均值(MAGE,p=0.007 和 0.034)来衡量。两组之间的差异没有达到统计学意义。维格列汀还显著降低了平均血糖标准差(SD)和平均每日差值(MODD)(p=0.007 和 0.030)。

结论

在 24 周的治疗后,维格列汀和格列齐特 MR 同样降低了 T2DM 女性的 MAGE。需要进一步的研究来证实维格列汀和格列齐特 MR 在血糖变异性方面的差异。

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