Effect of combination therapy with repaglinide and metformin hydrochloride on glycemic control in Japanese patients with type 2 diabetes mellitus.
Effect of combination therapy with repaglinide and metformin hydrochloride on glycemic control in Japanese patients with type 2 diabetes mellitus.
复制标题
DOI：
10.1111/jdi.12121
复制
发表时间：
2014-02-12
影响因子：
3.2
通讯作者：
Hotta N
中科院分区：
文献类型：
--
作者：
Kawamori R;Kaku K;Hanafusa T;Oikawa T;Kageyama S;Hotta N
我们研究了瑞格列奈作为二甲双胍单药治疗（主要剂量为1，500 mg/天）加饮食和运动治疗的日本2型糖尿病患者的辅助治疗的疗效和安全性。在为期16周的多中心、安慰剂对照、随机、双盲、平行组试验（III期研究）中，接受二甲双胍单药治疗的2型糖尿病患者被随机分配至瑞格列奈组或安慰剂组。此后，将一项为期36周、多中心、非对照、剂量滴定方法研究延长至总持续时间为52周（长期研究）。每项研究的主要终点是糖化血红蛋白（HbA 1c）较基线的变化。16周后，瑞格列奈组HbA 1c的平均下降幅度显著大于安慰剂组（-0.98 ± 0.72% vs 0.13 ± 0.63%，P < 0.001）。在长期研究中，HbA 1c的平均变化为−0.76 ± 0.83%。在III期研究中，瑞格列奈组和安慰剂组的不良事件发生率分别为60.6%和50.0%，在长期研究中为78.3%。瑞格列奈组、安慰剂组和长期研究中分别有11.7%、0%和13.3%的患者报告低血糖。瑞格列奈和二甲双胍联合治疗导致第16周时HbA 1c降低约1%，研究结束时HbA 1c长期显著改善。瑞格列奈和二甲双胍合并使用期间未观察到安全性问题。这些研究已在JapicCTI注册（nos. JapicCTI-101202和JapicCTI-101203）。
We investigated the efficacy and safety of repaglinide as an add‐on therapy for Japanese patients with type 2 diabetes mellitus receiving metformin monotherapy (at a dose of 1,500 mg/day, mainly) in addition to diet and exercise. In the 16‐week multicenter, placebo‐controlled, randomized, double‐blind, parallel‐group trial (the phase III study), patients with type 2 diabetes mellitus with metformin monotherapy were randomly assigned to the repaglinide or placebo group. Thereafter, a 36‐week, multicenter, uncontrolled, dose‐titration method study was extended to a total duration of 52 weeks (the long‐term study). The primary end‐point of each study was a change in glycated hemoglobin (HbA1c) from baseline. After 16 weeks, mean reductions in HbA1c were significantly greater for the repaglinide group than for the placebo group (–0.98 ± 0.72% vs 0.13 ± 0.63%, P < 0.001). In the long‐term study, the mean change in HbA1c was −0.76 ± 0.83%. The rate of adverse events was 60.6 and 50.0% in the repaglinide and placebo groups, respectively, in the phase III study, and 78.3% in the long‐term study. Hypoglycemia was reported in 11.7, 0 and 13.3% of patients in the repaglinide group, placebo group and long‐term study, respectively. Combination therapy with repaglinide and metformin resulted in an approximately 1% reduction in HbA1c at week 16 and in a significant long‐term improvement in HbA1c at the end of the study. No safety problems were noted during the concomitant use of repaglinide and metformin. These studies were registered with JapicCTI (nos. JapicCTI‐101202 and JapicCTI‐101203).
登录
查看更多内容
影响因子：
105.7
作者：
Stratton, IM;Adler, AI;Holman, RR
通讯作者：
Holman, RR
影响因子：
--
作者：
Borch-Johnsen, K;Neil, A;Qiao, Q
通讯作者：
Qiao, Q
影响因子：
5.1
作者：
OHKUBO, Y;KISHIKAWA, H;SHICHIRI, M
通讯作者：
SHICHIRI, M
影响因子：
3.2
作者：
Kashiwagi, Atsunori;Kasuga, Masato;Ohashi, Hatsumi
通讯作者：
Ohashi, Hatsumi
影响因子：
158.5
作者：
SHAMOON, H;DUFFY, H;SIEBERT, C
通讯作者：
SIEBERT, C