Inagaki Nobuya, Araki Eiichi, Oura Tomonori, Matsui Akiko, Takeuchi Masakazu, Tanizawa Yukio
Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
Diabetes Obes Metab. 2016 Dec;18(12):1279-1282. doi: 10.1111/dom.12758. Epub 2016 Sep 8.
The efficacy and safety of once-weekly dulaglutide 0.75 mg (dulaglutide) in Japanese patients with type 2 diabetes (T2D) were evaluated according to subgroups defined by concomitant oral hypoglycaemic agents. This exploratory analysis included data from a randomized, open-label, phase III study that compared dulaglutide with insulin glargine (glargine) (n = 361). The three subgroups were dulaglutide or glargine in combination with sulphonylurea (SU) alone, biguanide (BG) alone or SU and BG combined. There were no clinically relevant differences in glycated haemoglobin (HbA1c) changes among the three subgroups in the dulaglutide group; in the glargine group, a numerically greater reduction was observed in combination with BG alone compared to the other two groups (SU alone and SU + BG). Weight loss was observed with dulaglutide in combination with BG alone or with SU + BG. The incidence of adverse events among subgroups was significantly different in the glargine group but not in the dulaglutide group. Incidence of hypoglycaemia was highest in combination with SU for both treatments. For patients with T2D, dulaglutide added to concomitant BG may be more likely to result in weight loss than dulaglutide added to concomitant SU.
根据同时使用的口服降糖药所定义的亚组，评估了每周一次注射0.75毫克度拉糖肽（dulaglutide）在日本2型糖尿病（T2D）患者中的疗效和安全性。这项探索性分析纳入了一项随机、开放标签的III期研究的数据，该研究比较了度拉糖肽与甘精胰岛素（glargine）（n = 361）。三个亚组分别为度拉糖肽或甘精胰岛素单独与磺脲类药物（SU）联合使用、单独与双胍类药物（BG）联合使用或与SU和BG联合使用。度拉糖肽组的三个亚组之间糖化血红蛋白（HbA1c）变化无临床相关差异；在甘精胰岛素组中，与单独使用SU和SU + BG的其他两组相比，单独与BG联合使用时糖化血红蛋白降低幅度在数值上更大。度拉糖肽与单独使用BG或与SU + BG联合使用时可观察到体重减轻。甘精胰岛素组亚组间不良事件发生率有显著差异，而度拉糖肽组无显著差异。两种治疗方法中，与SU联合使用时低血糖发生率最高。对于T2D患者，在同时使用BG的基础上加用度拉糖肽可能比在同时使用SU的基础上加用度拉糖肽更易导致体重减轻。
