Comparison of tofogliflozin versus glimepiride as the third oral agent added to metformin plus a dipeptidyl peptidase-4 inhibitor in Japanese patients with type 2 diabetes: A randomized, 24-week, open-label, controlled trial (STOP-OB)
Comparison of tofogliflozin versus glimepiride as the third oral agent added to metformin plus a dipeptidyl peptidase-4 inhibitor in Japanese patients with type 2 diabetes: A randomized, 24-week, open-label, controlled trial (STOP-OB)
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DOI：
10.1111/dom.14059
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发表时间：
2020-05-07
影响因子：
5.8
通讯作者：
Ishihara, Hisamitsu
中科院分区：
文献类型：
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作者：
Kitazawa, Toru;Seino, Hiroaki;Ishihara, Hisamitsu
二甲双胍加二肽基肽酶 4 抑制剂 (DPP-4i) 是日本 2 型糖尿病患者最常见的治疗方法。这项为期 24 周、多中心、开放标签、平行组试验将接受双重治疗的患者随机分配至附加托格列净（20 毫克/天，n = 33）或格列美脲（0.5 毫克/天，n = 31）。主要结果是体脂百分比的变化。次要结果包括 HbA1c、脂肪量、去脂量、肝功能变量和尿酸的变化。托福格列净和格列美脲降低 HbA1c 的程度相似。两组的体脂百分比相对于基线均没有变化。托格列净减少了脂肪量，但格列美脲增加了脂肪量（-2.0 +/- 1.7 kg 和 +1.6 +/- 1.6 kg，P = .002）。托福格列净也减少了去脂体重，格列美脲则增加了去脂体重（分别减少-1.3 +/- 1.3 kg 和+0.9 +/- 2.0 kg，P < .001）。托福格列净可降低丙氨酸转氨酶和尿酸水平（分别为 P = .006 和 P < .001）。这些数据提供了新的信息，有助于为二甲双胍加 DPP-4i 双重疗法控制不佳的糖尿病患者选择第三种口服药物。
Metformin plus a dipeptidyl peptidase-4 inhibitor (DPP-4i) is the most common therapy for Japanese patients with type 2 diabetes. This 24-week, multicentre, open-label, parallel-group trial randomized patients on dual therapy to add-on tofogliflozin (20 mg/day, n = 33) or glimepiride (0.5 mg/day, n = 31). The primary outcome was change in body fat percentage. The secondary outcomes included changes in HbA1c, fat mass, fat-free mass, liver function variables and uric acid. Tofogliflozin and glimepiride reduced HbA1c to a similar extent. Body fat percentage did not change from baseline in either group. Fat mass was reduced by tofogliflozin but was increased by glimepiride (by -2.0 +/- 1.7 kg and +1.6 +/- 1.6 kg, P = .002). Fat-free mass was also reduced by tofogliflozin and increased by glimepiride (by -1.3 +/- 1.3 kg and +0.9 +/- 2.0 kg, P < .001). Alanine aminotransferase and uric acid levels were reduced by tofogliflozin (P = .006 and P < .001, respectively). These data provide novel information useful for selecting the third oral agent for patients whose diabetes is inadequately controlled with metformin plus DPP-4i dual therapy.