Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Department of Diabetes, Endocrinology, and Nutrition, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Diabetes Obes Metab. 2018 Feb;20(2):453-457. doi: 10.1111/dom.13079. Epub 2017 Sep 15.
Dipeptidyl peptidase-4 (DPP-4) inhibitors and sodium glucose co-transporter 2 (SGLT2) inhibitors are frequently used in combination for the treatment of type 2 diabetes mellitus (T2DM). We examined the efficacy and safety of teneligliptin (a DPP-4 inhibitor) added to canagliflozin (an SGLT2 inhibitor) monotherapy in Japanese patients with poorly controlled T2DM as part of the development of a fixed-dose combination of teneligliptin and canagliflozin. Japanese patients treated with canagliflozin (100 mg) for ≥12 weeks were randomized to receive add-on teneligliptin (20 mg; C + T group) or placebo (C + P group) for 24 weeks. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to Week 24. The between-group differences in reductions from baseline to Week 24 were significantly greater in the C + T group for HbA1c (-0.94%; P < .001). The incidence of adverse events was similar in both groups (55.8% and 49.4% in the C + T and C + P groups, respectively). No episodes of hypoglycaemia were reported. Teneligliptin added to ongoing canagliflozin monotherapy improved glycaemic control and was well tolerated in Japanese patients with inadequately controlled T2DM.
二肽基肽酶-4（DPP-4）抑制剂和钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂常用于联合治疗 2 型糖尿病（T2DM）。我们研究了在二肽基肽酶-4 抑制剂替格列汀（teneligliptin）基础上加用钠-葡萄糖共转运蛋白 2 抑制剂卡格列净（canagliflozin）在血糖控制不佳的日本 T2DM 患者中的疗效和安全性，这是替格列汀和卡格列净固定剂量复方制剂开发的一部分。接受卡格列净（100mg）治疗≥12 周的日本患者被随机分为加用替格列汀（20mg；C + T 组）或安慰剂（C + P 组）治疗 24 周。主要终点是从基线到第 24 周时糖化血红蛋白（HbA1c）的变化。C + T 组 HbA1c 从基线到第 24 周的降低幅度与 C + P 组相比有显著差异（-0.94%；P <.001）。两组不良反应发生率相似（C + T 组和 C + P 组分别为 55.8%和 49.4%）。无低血糖报告。替格列汀联合卡格列净持续治疗可改善血糖控制，在血糖控制不佳的日本 T2DM 患者中耐受性良好。
