Effect of patient characteristics on the efficacy and safety of imeglimin monotherapy in Japanese patients with type 2 diabetes mellitus: A post-hoc analysis of two randomized, placebo-controlled trials

IF 3.2 3区 医学
Katsuhiko Hagi, Kenji Kochi, Hirotaka Watada, Kohei Kaku, Kohjiro Ueki
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引用次数: 1

Abstract

Aims/Introduction

Substantial variability in demographic and clinical characteristics exists among patients with type 2 diabetes mellitus, which may impact treatment. This post-hoc analysis evaluated the efficacy and safety of imeglimin 1,000 mg twice daily (BID) monotherapy in type 2 diabetes mellitus patients according to demographic and clinical characteristics.

Materials and Methods

Data were pooled from two placebo-controlled, 24 week, randomized, double-blind studies in adults with type 2 diabetes mellitus. Outcomes (least squares mean [LSM] change in HbA1c from baseline to week 24, and safety) were analyzed according to subgroups based on demographics, clinical characteristics, and comorbidities.

Results

The difference in LSM change in HbA1c from baseline to week 24 was statistically significant for imeglimin vs placebo in all patient subgroups analyzed (P < 0.05 each), including demographics (age, body mass index), clinical characteristics (duration of type 2 diabetes mellitus, chronic kidney disease [CKD] stage, and prior medication use) and comorbidities (hypertension, dyslipidemia, risk of hepatic fibrosis and liver function parameter status). A statistically significant separation from placebo in HbA1c was observed at week 4 and maintained through week 24. No new safety concerns were identified with imeglimin in any patient subpopulations.

Conclusions

The efficacy and safety of imeglimin was demonstrated across patient subgroups, irrespective of baseline demographic and clinical characteristics. Our findings confirm the efficacy and safety of imeglimin across a broad spectrum of patients with type 2 diabetes mellitus.

患者特征对日本2型糖尿病患者伊美霉素单药治疗的疗效和安全性的影响:两项随机、安慰剂对照试验的事后分析
2型糖尿病患者的人口学和临床特征存在很大差异,这可能会影响治疗。根据人口统计学和临床特征,本事后分析评估了伊美美明1000 mg每日两次(BID)单药治疗2型糖尿病患者的疗效和安全性。资料和方法数据来自两项安慰剂对照、24周、随机、双盲的成人2型糖尿病研究。结果(HbA1c从基线到第24周的最小二乘平均值[LSM]变化和安全性)根据人口统计学、临床特征和合并症按亚组进行分析。结果在分析的所有患者亚组中,伊美米明与安慰剂的HbA1c从基线到第24周的LSM变化差异均有统计学意义(P < 0.05),包括人口统计学(年龄、体重指数)、临床特征(2型糖尿病病程、慢性肾脏疾病[CKD]分期、既往用药)和合共病(高血压、血脂异常、肝纤维化风险和肝功能参数状态)。在第4周观察到HbA1c与安慰剂的显著分离,并维持到第24周。未发现在任何患者亚群中使用伊米霉素有新的安全性问题。结论:无论基线人口统计学和临床特征如何,伊美霉素的有效性和安全性在患者亚组中都得到了证明。我们的研究结果证实了伊米霉素在广泛的2型糖尿病患者中的有效性和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Diabetes Investigation
Journal of Diabetes Investigation Medicine-Internal Medicine
自引率
9.40%
发文量
218
期刊介绍: Journal of Diabetes Investigation is your core diabetes journal from Asia; the official journal of the Asian Association for the Study of Diabetes (AASD). The journal publishes original research, country reports, commentaries, reviews, mini-reviews, case reports, letters, as well as editorials and news. Embracing clinical and experimental research in diabetes and related areas, the Journal of Diabetes Investigation includes aspects of prevention, treatment, as well as molecular aspects and pathophysiology. Translational research focused on the exchange of ideas between clinicians and researchers is also welcome. Journal of Diabetes Investigation is indexed by Science Citation Index Expanded (SCIE).
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