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[利拉鲁肽与格列美脲对墨西哥队列2型糖尿病患者血糖控制的影响(LEAD 3)]

[Liraglutide and glimepiride on glycaemic control in type 2 diabetes in the Mexican cohort (LEAD 3)].

作者信息

García-Hernández Pedro, Arechavaleta-Granell María del Rosario, Yamamoto Jorge, Falahati Ali, González-Gálvez Guillermo

机构信息

Servicio de Endocrinología, Hospital Universitario de Monterrey "Dr. José Eleuterio González," Monterrey, Nuevo León, México.

出版信息

Rev Med Inst Mex Seguro Soc. 2010 Sep-Oct;48(5):543-8.

Abstract

OBJECTIVE

To compare the efficacy of liraglutide monotherapy with glimepiride monotherapy in subjects with DM2 inadequately controlled by previous treatment of diet/exercise or oral antidiabetic drug.

METHODS

A 52-week, double-blinded, active-controlled, parallel-group, multi-centre, prospective trial, involving 746 subjects was conducted in the USA and Mexico. In Mexico, 171 subjects were rando-mised (1:1:1) to once daily liraglutide (either 1.2, or 1.8 mg/day injected subcutaneously) or glimepiride (8 mg/day orally).

RESULTS

Hb1Ac reduced by 0.64%, 1.31% and 0.30% with glimepiride, liraglutide 1.8 mg and 1.2 mg, respectively. Body weight decreased with both liraglutide doses while a weight gain of 0.94 kg was observed with glimepiride. FPG reduced by 27.9 mg/dL with liraglutide 1.8 mg, whereas a FPG increase of 9.54 mg/dL was shown with glimepiride. No major hypoglycaemic episodes were reported in this trial.

CONCLUSIONS

in Mexican subjects with DM2, liraglutide monotherapy can provide greater reduction in HbA1c, weight loss and lower risk of hypoglycaemia in comparison with glimepiride.

摘要

目的

比较利拉鲁肽单药治疗与格列美脲单药治疗对饮食/运动或口服抗糖尿病药物前期治疗控制不佳的2型糖尿病(DM2)患者的疗效。

方法

在美国和墨西哥进行了一项为期52周、双盲、活性对照、平行组、多中心前瞻性试验,纳入746名受试者。在墨西哥,171名受试者被随机分为三组(1:1:1),分别接受每日一次的利拉鲁肽(皮下注射1.2或1.8mg/天)或格列美脲(口服8mg/天)治疗。

结果

格列美脲、1.8mg利拉鲁肽和1.2mg利拉鲁肽治疗后,糖化血红蛋白(Hb1Ac)分别降低0.64%、1.31%和0.30%。两种剂量的利拉鲁肽均使体重下降,而格列美脲使体重增加0.94kg。1.8mg利拉鲁肽使空腹血糖(FPG)降低27.9mg/dL,而格列美脲使FPG升高9.54mg/dL。该试验未报告严重低血糖事件。

结论

在墨西哥的DM2患者中,与格列美脲相比,利拉鲁肽单药治疗可使糖化血红蛋白降低幅度更大、体重减轻且低血糖风险更低。

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