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利西拉来联合甘精胰岛素降低血糖控制不佳的日本 2 型糖尿病患者的残余血糖:来自 LixiLan JP-L 试验的事后分析。

iGlarLixi reduces residual hyperglycemia in Japanese patients with type 2 diabetes uncontrolled on basal insulin: A post-hoc analysis of the LixiLan JP-L trial.

机构信息

Department of Diabetes, Endocrinology and Metabolism, Gifu University Graduate School of Medicine, Gifu, Japan.

Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan.

出版信息

J Diabetes Investig. 2021 Nov;12(11):1992-2001. doi: 10.1111/jdi.13563. Epub 2021 Jun 19.

Abstract

INTRODUCTION

Treatments for type 2 diabetes targeting baseline glucose levels but not postprandial glucose can result in normalized fasting blood glucose but suboptimal overall glycemic control (high glycated hemoglobin): residual hyperglycemia. In Japanese patients with type 2 diabetes the predominant pathophysiology is a lower insulin secretory capacity, and residual hyperglycemia is common with basal insulin treatment. Single-injection, fixed-ratio combinations of glucagon-like peptide-1 receptor agonists and basal insulin have been developed. iGlarLixi (insulin glargine 100 units/mL [iGlar]: lixisenatide ratio of 1 unit:1 µg) is for specific use in Japan. Post-hoc analysis of the LixiLan JP-L trial (NCT02752412) compared the effect of iGlarLixi with iGlar on this specific subpopulation with residual hyperglycemia.

MATERIALS AND METHODS

Outcomes at week 26 (based on the last observation carried forward) were assessed in patients in the modified intent-to-treat population with baseline residual hyperglycemia.

RESULTS

Overall, 83 (32.5%) patients in the iGlarLixi group and 79 (30.7%) patients in the iGlar group had baseline residual hyperglycemia. The proportion of patients with residual hyperglycemia at week 26 decreased to 15.7% in the iGlarLixi group, and increased to 36.9% in the iGlar group. Patients in the iGlarLixi group had significantly greater reductions in glycated hemoglobin compared with the iGlar group (-0.72% difference between groups; P < 0.0001).

CONCLUSIONS

New data from this post-hoc analysis of the JP-L trial show that treatment with the fixed-ratio combination iGlarLixi reduced the proportion of Japanese patients with residual hyperglycemia from baseline to week 26 and significantly reduced glycated hemoglobin vs similar doses of iGlar alone.

摘要

简介

针对基础血糖水平而非餐后血糖的 2 型糖尿病治疗方法可能会使空腹血糖正常化,但总体血糖控制不理想(糖化血红蛋白高):仍存在高血糖。在日本 2 型糖尿病患者中,主要的病理生理学改变是胰岛素分泌能力降低,而基础胰岛素治疗常伴有残余高血糖。现已开发出胰高血糖素样肽-1 受体激动剂和基础胰岛素的单次注射、固定比例组合。iGlarLixi(胰岛素 glargine 100 单位/毫升 [iGlar]:lixisenatide 比例为 1 单位:1μg)专为日本使用。LixiLan JP-L 试验(NCT02752412)的事后分析比较了 iGlarLixi 与 iGlar 在具有残余高血糖的这一特定亚群中的疗效。

材料和方法

在基线残余高血糖的改良意向治疗人群中,根据最后一次观察向前(LOCF)评估第 26 周的结局。

结果

总体而言,iGlarLixi 组 83 例(32.5%)和 iGlar 组 79 例(30.7%)患者基线存在残余高血糖。iGlarLixi 组在第 26 周时仍有高血糖的患者比例下降至 15.7%,而 iGlar 组则上升至 36.9%。与 iGlar 组相比,iGlarLixi 组患者的糖化血红蛋白降低更显著(两组间差异为-0.72%;P<0.0001)。

结论

来自 JP-L 试验的这一事后分析的新数据表明,固定比例组合 iGlarLixi 的治疗使基线时存在残余高血糖的日本患者比例从第 26 周开始降低,并显著降低了糖化血红蛋白,而其与单独使用类似剂量的 iGlar 相比。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aebd/8565419/2ffc96218803/JDI-12-1992-g001.jpg

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