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首页> 外文期刊>Diabetes care >Efficacy and Safety of Imeglimin Monotherapy Versus Placebo in Japanese Patients With Type 2 Diabetes (TIMES 1): A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Phase 3 Trial
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Efficacy and Safety of Imeglimin Monotherapy Versus Placebo in Japanese Patients With Type 2 Diabetes (TIMES 1): A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Phase 3 Trial

机译：日本患有2型糖尿病患者的IMEGLIMIN单疗法与安慰剂的疗效和安全性（时序1）：双盲，随机，安慰剂控制，并联组，多中心3阶段试验

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OBJECTIVE The aim of this study was to investigate the efficacy and safety of imeglimin, the first in a new class of oral antidiabetic agent, in Japanese patients with type 2 diabetes. RESEARCH DESIGN AND METHODS This was a double-blind, randomized, parallel-group, placebo-controlled phase 3 trial in 30 sites in Japan. Eligible participants were individuals aged >= 20 years with type 2 diabetes treated with diet and exercise, stable for >= 12 weeks prior to screening, and whose HbA(1c) was 7.0-10.0% (53-86 mmol/mol). Patients were randomly assigned (1:1) to either oral imeglimin (1,000 mg twice daily) or matched placebo for 24 weeks. Investigators, participants, and the sponsor of the study remained blinded throughout the trial. The primary end point was the change in mean HbA(1c) from baseline to week 24, and the key secondary end point was the percentage of responders (according to two definitions) at week 24. RESULTS Between 26 December 2017 and 1 February 2019, 106 and 107 patients were randomly assigned to treatment with imeglimin and placebo, respectively. Compared with placebo, the adjusted mean difference in change from baseline HbA(1c) at week 24 was -0.87% (95% CI -1.04 to -0.69 [-9.5 mmol/mol; 95% CI -11.4 to -7.5]; P = 1 adverse event in the imeglimin group versus 48 adverse events (44.9%) in the placebo group. CONCLUSIONS Imeglimin significantly improved HbA(1c) in Japanese patients with type 2 diabetes compared with placebo and had a similar safety profile to placebo. Imeglimin represents a potential new treatment option for this population.
机译：目的本研究的目的是研究新型口服降糖药中的第一种伊美格列明对日本2型糖尿病患者的疗效和安全性。研究设计和方法这是一项双盲、随机、平行组、安慰剂对照的3期试验，在日本的30个地点进行。符合条件的参与者为年龄大于等于20岁的2型糖尿病患者，接受饮食和运动治疗，筛查前稳定时间大于等于12周，HbA1c为7.0-10.0%（53-86 mmol/mol）。患者被随机分配（1:1）口服伊美格列明（1000 mg，每日两次）或配对安慰剂24周。在整个试验过程中，研究人员、参与者和研究赞助者仍然是盲目的。主要终点是从基线检查到第24周平均HbA（1c）的变化，关键的次要终点是第24周应答者的百分比（根据两个定义）。结果在2017年12月26日至2019年2月1日期间，106名和107名患者分别被随机分配到伊美格列明和安慰剂治疗组。与安慰剂相比，在第24周，与基线HbA（1c）相比，调整后的平均变化差异为-0.87%（95%可信区间-1.04至-0.69[-9.5 mmol/mol；95%可信区间-11.4至-7.5]；依格列明组的P=1例不良事件与安慰剂组的48例不良事件（44.9%）相比。结论与安慰剂相比，伊美格列明显著改善了日本2型糖尿病患者的HbA（1c），且其安全性与安慰剂相似。伊美格列明代表了这一人群潜在的新治疗选择。

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