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首页> 外文期刊>BMJ Open Diabetes Research & Care >Pleiotropic effects of sitagliptin versus voglibose in patients with type 2 diabetes inadequately controlled via diet and/or a single oral antihyperglycemic agent: a multicenter, randomized trial
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Pleiotropic effects of sitagliptin versus voglibose in patients with type 2 diabetes inadequately controlled via diet and/or a single oral antihyperglycemic agent: a multicenter, randomized trial

机译：西他列汀与伏格列波糖对2型糖尿病患者饮食和/或单一口服降糖药控制不良的多效性研究：一项多中心随机试验

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Purpose A step-up strategy for diet therapy and/or single oral antihyperglycemic agent (OHA) regimens has not yet been established. The aim of this study was to evaluate hemoglobin A1c (HbA1c) as a primary end point, and the pleiotropic effects on metabolic and cardiovascular parameters as secondary end points, of sitagliptin versus voglibose in patients with type 2 diabetes with inadequate glycemic control while on diet therapy and/or treatment with a single OHA. Methods In this multicenter, randomized, open-label, parallel-group trial, a total of 260 patients with inadequately controlled type 2 diabetes (HbA1c levels 6.9%) were randomly assigned to receive either sitagliptin (50?mg, once daily) or voglibose (0.6?mg, thrice daily) for 12?weeks. The primary end point was HbA1c levels. Results Patients receiving sitagliptin showed a significantly greater decrease in HbA1c levels (?0.78±0.69%) compared with those receiving voglibose (?0.30±0.78%). Sitagliptin treatment also lowered serum alkaline phosphatase levels and increased serum creatinine, uric acid, cystatin-C and homeostasis model assessment-β values. Voglibose increased low-density lipoprotein-cholesterol levels and altered serum levels of several fatty acids, and increased Δ-5 desaturase activity. Both drugs increased serum adiponectin. The incidence of adverse events (AEs) was significantly lower in the sitagliptin group, due to the decreased incidence of gastrointestinal AEs. Conclusions Sitagliptin shows superior antihyperglycemic effects compared with voglibose as a first-line or second-line therapy. However, both agents possess unique pleiotropic effects that lead to reduced cardiovascular risk in Japanese people with type 2 diabetes. Trial registration number UMIN 000003503.
机译：目的尚未制定饮食疗法和/或单一口服降糖药（OHA）方案的增强策略。这项研究的目的是评估西他列汀与伏格列波糖对2型糖尿病患者饮食时血糖控制不足的主要终点为血红蛋白A1c（HbA1c），对代谢和心血管参数的多效性影响为次要终点。一个OHA进行治疗和/或治疗。方法在这项多中心，随机，开放标签，平行组的试验中，将总共260名2型糖尿病控制不佳（HbA1c水平> 6.9％）的患者随机分配接受西他列汀（50 mg，每天一次）或伏格列波糖（0.6？mg，每天三次），持续12周。主要终点是HbA1c水平。结果接受西他列汀治疗的患者与接受伏格列波糖治疗的患者相比，其HbA1c水平显着降低（？0.78±0.69％）（？0.30±0.78％）。西他列汀治疗还降低了血清碱性磷酸酶水平，并增加了血清肌酐，尿酸，胱抑素-C和体内稳态模型评估-β值。伏格列波糖增加了低密度脂蛋白胆固醇的水平，改变了几种脂肪酸的血清水平，并增加了Δ-5去饱和酶的活性。两种药物均增加血清脂联素。西他列汀组的不良事件（AEs）发生率显着降低，这是由于胃肠道AEs发生率降低所致。结论西格列汀作为一线或二线治疗药物比伏格列波糖具有更好的降血糖作用。但是，这两种药物均具有独特的多效作用，可降低日本2型糖尿病患者的心血管风险。试用注册号UMIN 000003503。

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