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中国 2 型糖尿病患者起始基础胰岛素治疗时血糖控制未达标及其相关因素的事后分析:FPG GOAL 研究。

Unmet Needs of Glycaemic Control and Risk Factors of Residual Hyperglycaemia in a Chinese Population with Type 2 Diabetes Initiating Basal Insulin: A Post Hoc Analysis of the FPG GOAL Study.

机构信息

Department of Endocrinology, China-Japan Friendship Hospital, Beijing, 100029, China.

Sanofi Medical, Shanghai, China.

出版信息

Adv Ther. 2022 Jun;39(6):2820-2830. doi: 10.1007/s12325-022-02128-y. Epub 2022 Apr 16.

Abstract

INTRODUCTION

To aim of this analysis was to investigate the extent and evaluate risk factors of residual hyperglycaemia in Chinese individuals with type 2 diabetes (T2D) initiating basal insulin.

METHODS

FPG GOAL was a 24-week, open-label, treat-to-target randomised controlled trial in Chinese individuals with T2D inadequately controlled with oral anti-hyperglycaemic drugs initiating treatment with basal insulin. This analysis categorised participants into the following glycaemic control categories: hyperglycaemia [glycated haemoglobin (HbA1c) ≥ 53 mmol/mol (≥ 7%), fasting plasma glucose (FPG) ≥ 7.0 mmol/L], residual hyperglycaemia [HbA1c ≥ 53 mmol/mol (≥ 7%), FPG < 7.0 mmol/L], discordant [HbA1c < 53 mmol/mol (< 7%), FPG ≥ 7.0 mmol/L] and at target [HbA1c < 53 mmol/mol (< 7%), FPG < 7.0 mmol/L]. The proportion of participants in each glycaemic control category was assessed at weeks 12 and 24. Multivariable regression analyses were conducted to evaluate risk factors for residual hyperglycaemia.

RESULTS

Of the 914 participants included, 22.1% had residual hyperglycaemia, 31.9% had hyperglycaemia, 11.1% were discordant and 29.3% were at target at week 24. More participants who were randomised to a fasting blood glucose (FBG) target of > 3.9 to ≤ 5.6 mmol/L had residual hyperglycaemia compared with participants randomised to a FBG target of > 3.9 to ≤ 6.1 mmol/L or > 3.9 to ≤ 7.0 mmol/L. Multivariable analysis indicated that higher HbA1c and lower FPG levels at baseline were associated with greater proportion of residual hyperglycaemia.

CONCLUSION

Some Chinese individuals with T2D may have residual hyperglycaemia 3-6 months after initiating basal insulin treatment and require further intensified treatment. Higher HbA1c and lower FPG levels could be risk factors for residual hyperglycaemia.

TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT02545842.

摘要

简介

本分析旨在研究中国 2 型糖尿病(T2D)患者起始基础胰岛素治疗后残余高血糖的程度和评估其相关风险因素。

方法

FPG GOAL 是一项为期 24 周、开放标签、以目标为导向的随机对照临床试验,研究对象为口服降糖药治疗控制不佳的中国 T2D 患者,起始基础胰岛素治疗。本分析将参与者分为以下血糖控制类别:高血糖[糖化血红蛋白(HbA1c)≥53mmol/mol(≥7%),空腹血糖(FPG)≥7.0mmol/L]、残余高血糖[HbA1c≥53mmol/mol(≥7%),FPG<7.0mmol/L]、血糖不达标且高血糖[HbA1c<53mmol/mol(<7%),FPG≥7.0mmol/L]和血糖达标[HbA1c<53mmol/mol(<7%),FPG<7.0mmol/L]。分别于第 12 周和第 24 周评估每个血糖控制类别的参与者比例。采用多变量回归分析评估残余高血糖的风险因素。

结果

914 名参与者中,22.1%有残余高血糖,31.9%有高血糖,11.1%血糖不达标,29.3%血糖达标。与随机血糖目标设定为 3.9 至 5.6mmol/L 相比,随机血糖目标设定为 3.9 至 6.1mmol/L 或 3.9 至 7.0mmol/L 的参与者发生残余高血糖的比例更高。多变量分析表明,基线时 HbA1c 更高和 FPG 水平更低与残余高血糖比例增加相关。

结论

一些中国 T2D 患者在起始基础胰岛素治疗后 3-6 个月可能仍有残余高血糖,需要进一步强化治疗。较高的 HbA1c 和较低的 FPG 水平可能是残余高血糖的风险因素。

试验注册

ClinicalTrials.gov 标识符 NCT02545842。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d07/9123059/baff7ec09919/12325_2022_2128_Fig1_HTML.jpg

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