每周一次的二肽基肽酶4抑制剂奥格列汀对维持性血液透析的2型糖尿病患者血糖控制的影响：一项24周开放标签、多中心随机对照研究。
Effects of the Once-Weekly DPP4 Inhibitor Omarigliptin on Glycemic Control in Patients with Type 2 Diabetes Mellitus on Maintenance Hemodialysis: A 24-Week Open-Label, Multicenter Randomized Controlled Study.
作者信息
Yoshizawa Yuta, Hosojima Michihiro, Kabasawa Hideyuki, Tanabe Naohito, Ugamura Daisuke, Koda Yutaka, Shimada Hisaki, Takasawa Tetsuya, Ito Takahito, Kitamura Tadahiro, Kobayashi Masaki, Suzuki Yoshiki, Narita Ichiei, Saito Akihiko
机构信息
Department of Applied Molecular Medicine, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan.
Department of Clinical Nephrology and Rheumatology, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, 951-8510, Japan.
出版信息
Diabetes Ther. 2021 Mar;12(3):655-667. doi: 10.1007/s13300-020-00991-y. Epub 2021 Jan 20.
INTRODUCTION
Dipeptidyl peptidase 4 (DPP4) inhibitors are widely used in patients with type 2 diabetes mellitus (T2DM) on maintenance hemodialysis (HD), but the efficacy of the once-weekly DPP4 inhibitor omarigliptin is not known.
METHODS
This prospective, randomized, open-label, parallel-group, non-inferiority/superiority, once-daily DPP4 inhibitor linagliptin-controlled, multicenter study examined glycemic control and safety of omarigliptin (UMIN000024284). Sample size was calculated to confirm non-inferiority in terms of changes in glycated hemoglobin (HbA1c). We enrolled 33 patients with T2DM on maintenance HD who had been treated with linagliptin for at least 3 months. The patients were randomized to receive omarigliptin (12.5 mg/week; n = 16) or linagliptin (5 mg/day; n = 17). Primary endpoints were changes in HbA1c and glycoalbumin (GA) over 24 weeks.
RESULTS
Differences in the mean change in primary endpoint values between the omarigliptin and linagliptin groups were - 0.61% [- 1.14, - 0.09] for HbA1c, with a two-tailed upper 95% limit (i.e., one-tailed 97.5% upper limit) of 0.25%, below the non-inferiority limit, and - 1.67% [- 4.23, + 0.88] for GA, with a two-tailed upper 95% limit of 0.75%, above the non-inferiority limit. At 24 weeks, the omarigliptin group showed significantly greater reduction in HbA1c than the linagliptin group (- 0.2% ± 0.6% vs. 0.4% ± 0.8%, two-tailed p = 0.024) and significantly greater reduction in blood glucose after a single HD session (- 18.4 ± 31.4 mg/dL vs. 25.2 ± 59.5 mg/dL, respectively, two-tailed p = 0.019). No subjects in the omarigliptin group developed hypoglycemia.
CONCLUSIONS
Our data showed that omarigliptin was non-inferior to linagliptin in glycemic control. Omarigliptin is feasible for glycemic control in patients with T2DM on maintenance HD.
CLINICAL TRIALS REGISTRATION
UMIN000024284.
引言
二肽基肽酶4（DPP4）抑制剂广泛应用于维持性血液透析（HD）的2型糖尿病（T2DM）患者，但每周一次的DPP4抑制剂奥格列汀的疗效尚不清楚。
方法
这项前瞻性、随机、开放标签、平行组、非劣效性/优效性、每日一次DPP4抑制剂利格列汀对照的多中心研究，考察了奥格列汀（UMIN000024284）的血糖控制情况和安全性。根据糖化血红蛋白（HbA1c）变化计算样本量以确认非劣效性。我们纳入了33例接受维持性HD且已接受利格列汀治疗至少3个月的T2DM患者。患者被随机分为接受奥格列汀（12.5mg/周；n = 16）或利格列汀（5mg/天；n = 17）。主要终点为24周内HbA1c和糖化白蛋白（GA）的变化。
结果
奥格列汀组和利格列汀组主要终点值的平均变化差异，HbA1c为-0.61%[-1.14，-0.09]，双尾95%上限（即单尾97.5%上限）为0.25%，低于非劣效性界值；GA为-1.67%[-4.23，+0.88]，双尾95%上限为0.75%，高于非劣效性界值。在24周时，奥格列汀组的HbA1c降低幅度显著大于利格列汀组（-0.2%±0.6%对0.4%±0.8%，双尾p = 0.024），且单次HD治疗后血糖降低幅度也显著更大（分别为-18.4±31.4mg/dL对25.2±59.5mg/dL，双尾p = 0.019）。奥格列汀组无受试者发生低血糖。
结论
我们的数据表明，奥格列汀在血糖控制方面不劣于利格列汀。奥格列汀对维持性HD的T2DM患者控制血糖是可行的。
临床试验注册
UMIN000024284。
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