Factors contributing to the clinical effectiveness of imeglimin monotherapy in Japanese patients with type 2 diabetes mellitus

IF 3.1 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Journal of Diabetes Investigation Pub Date : 2024-05-25 DOI:10.1111/jdi.14247

Katsuhiko Hagi, Kenji Kochi, Hirotaka Watada, Kohei Kaku, Kohjiro Ueki

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Abstract

Aims/Introduction

To investigate the effect of patient characteristics on imeglimin effectiveness in Japanese patients with type 2 diabetes mellitus.

Materials and Methods

Data were pooled from two randomized, placebo-controlled, 24-week, double-blind studies of imeglimin monotherapy in Japanese adults with type 2 diabetes mellitus, with the proportion of responders (glycated hemoglobin [HbA1c] < 7.0%) and sustained responders (i.e., achieved and maintained response) in the imeglimin 1,000 mg twice daily group calculated at each visit. Patient factors significantly (P < 0.05) correlated with response were explored through multivariate logistic regression. Subgroup analyses compared the efficacy of imeglimin in patients with a HbA1c improvement less than or equal to −0.3% (early responders) versus greater than −0.3% (early non-responders) at week 4.

Results

A total of 38.0% of imeglimin-treated patients and 7.2% of placebo-treated patients were responders (P < 0.001, number needed to treat = 4). The proportion of sustained responders at weeks 4, 8, 12, 16 and 20 was 10.6, 19.0, 24.0, 25.7 and 29.1%, respectively (>70% of responders at each visit). Improvements in HbA1c and fasting glucose were significantly greater in early responders versus early non-responders from week 4; between-group differences remained significant to week 24. Older age (odds ratio 1.09, 95% confidence interval 1.04–1.14; P < 0.001); treatment-naïve status vs previous treatment (odds ratio 3.70, 95% confidence interval 1.55–8.82; P = 0.003), and lower baseline HbA1c (odds ratio 0.06, 95% confidence interval 0.02–0.16; P < 0.001) predicted response.

Conclusions

A significantly higher proportion of patients receiving imeglimin 1,000 mg twice daily monotherapy were responders versus placebo. Most (>70%) were sustained responders, suggesting that response is fairly predictable. Older age, treatment-naïve status and early treatment response significantly predicted imeglimin effectiveness.

Abstract Image

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日本 2 型糖尿病患者接受伊麦角林单药治疗的临床疗效因素。

目的/简介：研究日本2型糖尿病患者中患者特征对伊迈格列明疗效的影响：对日本成年 2 型糖尿病患者进行的两项为期 24 周的伊迈格列明单药治疗随机、安慰剂对照、双盲研究的数据进行了汇总，结果显示应答者的比例（糖化血红蛋白[HbA1c] 结果：伊迈格列明单药治疗的应答者比例为 38.0%，伊迈格列明单药治疗的应答者比例为 7.0%，伊迈格列明单药治疗的应答者比例为 8.0%：38.0%的伊麦格列明治疗患者和 7.2%的安慰剂治疗患者有反应（每次就诊时有反应者的比例为 70%）。从第 4 周开始，早期应答者与早期未应答者相比，HbA1c 和空腹血糖的改善幅度明显更大；直到第 24 周，组间差异仍然显著。年龄偏大（几率比 1.09，95% 置信区间 1.04-1.14；P 结论：年龄偏大的患者在接受药物治疗的比例明显高于年龄偏小的患者：接受伊迈格列明 1,000 毫克、每天两次单药治疗的患者中，应答者比例明显高于安慰剂。大多数患者（>70%）是持续应答者，这表明应答是可以预测的。年龄较大、未接受过治疗和早期治疗反应显著预示着伊迈格列明的疗效。

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 ENDOCRINOLOGY & METABOLISM-

CiteScore

6.50

自引率

9.40%

发文量

218

审稿时长

6-12 weeks

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).