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度拉糖肽在中国2型糖尿病及不同血糖模式患者中的疗效:3期AWARD-CHN2试验的事后分析

Efficacy of Dulaglutide in Chinese Patients with Type 2 Diabetes and Different Glycemic Patterns: a Post-hoc Analysis of the Phase 3 AWARD-CHN2 Trial.

作者信息

Li Qifu, Zhang Qiqi, Wang Rui, Hong Tianpei

机构信息

Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.

Lilly Suzhou Pharmaceutical Co., Ltd, Shanghai Branch, No. 288 Shimen No.1 Road, Jingan District, Shanghai, 200041, China.

出版信息

Diabetes Ther. 2022 Jan;13(1):161-173. doi: 10.1007/s13300-021-01182-z. Epub 2021 Dec 6.

Abstract

INTRODUCTION

We evaluated the effect of dulaglutide on the relative contributions of fasting glucose (FG) and postprandial glucose (PPG) to overall hyperglycemia in patients with type 2 diabetes (T2D), and assessed responses to dulaglutide versus insulin glargine (glargine) in patients with different baseline glycemic patterns.

METHODS

This post-hoc analysis of the phase 3 AWARD-CHN2 trial included data from 560 Chinese patients with uncontrolled T2D who received once-weekly dulaglutide (1.5 or 0.75 mg) or once-daily glargine for 26 weeks. The relative contributions of FG and PPG to overall hyperglycemia across different glycated hemoglobin (HbA1c) categories were calculated using the area under the curve of 7-point self-monitored blood glucose profiles. Patients were also categorized into four subgroups according to median baseline FG (cutoff 8.9 mmol/L) and PPG (cutoff 12.5 mmol/L): low FG/low PPG, low FG/high PPG, high FG/low PPG and high FG/high PPG. Changes in glycemic parameters and body weight were calculated for patients in each subgroup.

RESULTS

Among patients receiving dulaglutide, higher HbA1c was associated with higher relative contributions of FG and lower relative contributions of PPG to overall hyperglycemia at baseline and week 26 of dulaglutide treatment. After 26 weeks, dulaglutide 1.5 mg led to statistically greater decreases in HbA1c from baseline versus glargine in most subgroups, including the high FG subgroups, and a numerically greater decrease in HbA1c was observed in the low FG/high PPG subgroup. Across all subgroups, higher proportions of patients achieved HbA1c ≤ 6.5% with dulaglutide 1.5 mg than with glargine (all P < 0.05). Dulaglutide 1.5 mg showed better control of body weight than glargine in all subgroups (all P < 0.05).

CONCLUSIONS

Dulaglutide reduced HbA1c through reductions in both FG and PPG across HbA1c categories in T2D patients with uncontrolled hyperglycemia. Furthermore, treatment with dulaglutide provided a greater reduction in HbA1c than glargine, regardless of baseline FG and PPG levels.

摘要

简介

我们评估了度拉糖肽对2型糖尿病(T2D)患者空腹血糖(FG)和餐后血糖(PPG)对总体高血糖相对贡献的影响,并评估了不同基线血糖模式的患者对度拉糖肽与甘精胰岛素(甘精)的反应。

方法

这项对3期AWARD-CHN2试验的事后分析纳入了560例未控制的T2D中国患者的数据,这些患者接受每周一次的度拉糖肽(1.5或0.75毫克)或每日一次的甘精胰岛素治疗26周。使用7点自我监测血糖曲线的曲线下面积计算FG和PPG对不同糖化血红蛋白(HbA1c)类别总体高血糖的相对贡献。患者还根据基线FG中位数(临界值8.9毫摩尔/升)和PPG中位数(临界值12.5毫摩尔/升)分为四个亚组:低FG/低PPG、低FG/高PPG、高FG/低PPG和高FG/高PPG。计算每个亚组患者的血糖参数和体重变化。

结果

在接受度拉糖肽治疗的患者中,较高的HbA1c与基线时以及度拉糖肽治疗第26周时FG对总体高血糖的较高相对贡献和PPG的较低相对贡献相关。26周后,在大多数亚组中,包括高FG亚组,度拉糖肽1.5毫克导致HbA1c较基线相比的下降在统计学上大于甘精胰岛素,并且在低FG/高PPG亚组中观察到HbA1c的数值下降更大。在所有亚组中,度拉糖肽1.5毫克组达到HbA1c≤6.5%的患者比例高于甘精胰岛素组(所有P<0.05)。在所有亚组中,度拉糖肽1.5毫克在控制体重方面均优于甘精胰岛素(所有P<0.05)。

结论

度拉糖肽通过降低未控制高血糖的T2D患者各HbA1c类别中的FG和PPG来降低HbA1c。此外,无论基线FG和PPG水平如何,度拉糖肽治疗比甘精胰岛素能更大程度地降低HbA1c。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ead5/8776932/4e2841cfc6b9/13300_2021_1182_Fig1_HTML.jpg

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