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首页> 外文期刊>Endocrine >Alogliptin as an initial therapy in patients with newly diagnosed, drug naïve type 2 diabetes: a randomized, control trial
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Alogliptin as an initial therapy in patients with newly diagnosed, drug naïve type 2 diabetes: a randomized, control trial

机译：阿格列汀作为新诊断的初治2型糖尿病患者的初始治疗：一项随机对照试验

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The objectives of this study is to evaluate the efficacy and safety of alogliptin versus very low fat/calorie traditional Japanese diet (non-inferiority trial) as an initial therapy for newly diagnosed, drug naïve subjects with type 2 diabetes (T2DM). Study design was prospective, randomized, non-double-blind, controlled trial. The study was conducted at outpatient units of municipal hospital. Patients were newly diagnosed, drug naïve patients who visited the outpatient units. The patients randomly received 12.5–25 mg/day alogliptin (n = 25) or severe low calorie traditional Japanese diet (n = 26). The procedure of this trial was assessed by the consolidated standards of reporting trials statement. The primary end point was the change of HbA1c at 3 months. Secondary end points included the changes of fasting blood glucose, insulin, homeostasis model assessment-R (HOMA-R), HOMA-B, body mass index (BMI), and lipid parameters. Similar, significant reductions of HbA1c levels were observed in both groups (from 10.51 to 8.74% for alogliptin and from 10.01 to 8.39% for traditional Japanese diet) without any clinically significant adverse events. In the alogliptin group, some subjects (16%) had mild hypoglycemic evens which could be managed by taking glucose drinks by themselves. HOMA-B significantly increased in both groups with varying degrees, whereas HOMA-R significantly decreased only in the Japanese diet group. Atherogenic lipids, such as, total cholesterol, non-high density lipoprotein cholesterol, and low density lipoprotein cholesterol levels significantly decreased in both groups. BMI had no change in the alogliptin group, whereas it significantly decreased in the Japanese diet group. (1) Concerning its glycemic efficacy, alogliptin is effective and non-inferior to traditional Japanese diet as an initial therapeutic option for newly diagnosed T2DM. However, regarding the reductions of body weight and insulin resistance, traditional Japanese diet is superior. (2) Both alogliptin and traditional Japanese diet have favorable effects on atherogenic lipid profiles.
机译：这项研究的目的是评估阿格列汀与低脂/低热量传统日本饮食（非劣效性试验）作为新诊断，初治的2型糖尿病（T2DM）受试者的初始疗法的疗效和安全性。研究设计是前瞻性，随机，非双盲，对照试验。该研究在市立医院的门诊部进行。患者是新诊断的，未曾接受过药物治疗的患者，曾就诊过门诊部。患者随机接受每天12.5–25 mg阿格列汀（n = 25）或严重的低热量日本传统饮食（n = 26）。该试验程序由报告试验报告的合并标准评估。主要终点是3个月时HbA1c的变化。次要终点包括空腹血糖，胰岛素，体内稳态模型评估-R（HOMA-R），HOMA-B，体重指数（BMI）和脂质参数的变化。相似地，两组均观察到HbA1c水平显着降低（阿格列汀从10.51％降低到8.74％，传统日本饮食从10.01％降低到8.39％），而没有任何临床上明显的不良事件。在阿格列汀组中，一些受试者（16％）的轻度降血糖均匀，可以通过自己服用葡萄糖饮料来控制。两组中HOMA-B均有不同程度的显着升高，而HOMA-R仅在日本饮食组中显着降低。两组的总胆固醇，非高密度脂蛋白胆固醇和低密度脂蛋白胆固醇等致动脉血脂均明显降低。阿格列汀组的BMI没有变化，而日本饮食组的BMI则显着下降。 （1）关于其降糖功效，阿格列汀是有效的且不逊于传统的日本饮食，是新诊断的T2DM的初始治疗选择。但是，就减轻体重和胰岛素抵抗而言，传统的日本饮食更为优越。 （2）阿格列汀和日本传统饮食对动脉粥样硬化性脂质的分布都有良好的影响。

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