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在2型糖尿病患者中,于正在进行的二甲双胍治疗基础上加用维格列汀或格列美脲的疗效及安全性。

The efficacy and safety of adding either vildagliptin or glimepiride to ongoing metformin therapy in patients with type 2 diabetes mellitus.

作者信息

Kim Gyuri, Oh Sewon, Jin Sang-Man, Hur Kyu Yeon, Kim Jae Hyeon, Lee Moon-Kyu

机构信息

a Division of Endocrinology and Metabolism, Department of Medicine , Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Republic of Korea.

出版信息

Expert Opin Pharmacother. 2017 Aug;18(12):1179-1186. doi: 10.1080/14656566.2017.1353080. Epub 2017 Jul 17.

DOI:10.1080/14656566.2017.1353080
PMID:28714741
Abstract

OBJECTIVE

To compare the effects of either vildagliptin or glimepiride on glycemic variability, oxidative stress, and endothelial parameters in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone.

METHODS

In this randomized, open-label, parallel study, 34 patients with T2DM being treated with metformin having an HbA1c of 7.0-10.0% were allocated into either the vildagliptin or glimepiride group. A mixed-meal tolerance test and 72-hour continuous glucose monitoring were conducted, and urinary 8-iso-prostaglandinF (PGF) and endothelial-dependent flow-mediated dilatation (FMD) were evaluated at baseline and after 12 weeks of treatment.

RESULTS

Similar significant improvements in HbA1c level were shown in both vildagliptin (-0.8%) and glimepiride (-0.9%) groups after treatment (Ps<0.001). The mean amplitude of glycemic excursions (MAGE) and the mean of daily differences (MODD) were significantly decreased by vildagliptin (P = 0.044 and P = 0.031, respectively) but not by glimepiride. Glimepiride was significantly associated with a higher incidence of hypoglycemia than vildagliptin (P = 0.005). There were no significant differences in urinary 8-iso-PGF or FMD between the two groups.

CONCLUSIONS

Vildagliptin effectively improved glucose level with a significantly greater reduction in glycemic variability and hypoglycemia than glimepiride in patients with T2DM ongoing metformin therapy. The two drugs showed no significant differences in urinary 8-iso-PGF and FMD.

TRIAL REGISTRATION

NCT01404676.

摘要

目的

比较维格列汀或格列美脲对仅用二甲双胍治疗血糖控制不佳的2型糖尿病(T2DM)患者血糖变异性、氧化应激和内皮参数的影响。

方法

在这项随机、开放标签、平行研究中,将34例接受二甲双胍治疗且糖化血红蛋白(HbA1c)为7.0 - 10.0%的T2DM患者分为维格列汀组或格列美脲组。进行混合餐耐量试验和72小时连续血糖监测,并在基线和治疗12周后评估尿8-异前列腺素F(PGF)和内皮依赖性血流介导的血管舒张功能(FMD)。

结果

治疗后维格列汀组(-0.8%)和格列美脲组(-0.9%)的HbA1c水平均有相似的显著改善(P<0.001)。维格列汀显著降低了血糖波动幅度(MAGE)和每日血糖平均绝对差(MODD)(分别为P = 0.044和P = 0.031),而格列美脲未降低。格列美脲导致低血糖的发生率显著高于维格列汀(P = 0.005)。两组间尿8-异PGF或FMD无显著差异。

结论

在接受二甲双胍治疗的T2DM患者中,维格列汀能有效改善血糖水平,与格列美脲相比,能更显著地降低血糖变异性和低血糖发生率。两种药物在尿8-异PGF和FMD方面无显著差异。

试验注册号

NCT01404676。

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