中文 2 型糖尿病患者空腹血糖目标对血糖变异性的影响：FPG GOAL 试验（BEYOND III）事后分析。

Influence of Fasting Plasma Glucose Targets on Glycemic Variability in Chinese Participants With Type 2 Diabetes: A Post Hoc Analysis of the FPG GOAL Trial (BEYOND III).

机构信息

Shengjing Hospital of China Medical University, Shenyang, China.

Jiangsu Province Hospital, Nanjing, China.

出版信息

Adv Ther. 2022 Jan;39(1):421-429. doi: 10.1007/s12325-021-01932-2. Epub 2021 Nov 10.

DOI:10.1007/s12325-021-01932-2

PMID:34757600

Abstract

INTRODUCTION

This post hoc analysis examines the relationship between glycemic variability (GV) and fasting plasma glucose (FPG) targets used to achieve glycated hemoglobin (HbA1c) < 7%, and HbA1c levels after 24 weeks of treatment with insulin glargine and oral antidiabetic drugs (OADs) in Chinese participants with type 2 diabetes mellitus (T2DM) from the BEYOND III FPG GOAL trial (NCT02545842).

METHODS

Participants were randomized for three FBG targets (≤ 5.6 mmol/L, ≤ 6.1 mmol/L, and ≤ 7.0 mmol/L) receiving insulin glargine 100 U/mL were analyzed for mean change from baseline to 24 weeks in postprandial glucose (PPG) excursion and FPG coefficient of variation (FPG-CV). The study analyzed change from baseline in HbA1c and the proportion of participants who achieved HbA1c < 7% at 24 weeks, according to their baseline FPG-CV and change from baseline in PPG excursion.

RESULTS

The change in PPG excursion and FPG-CV from baseline to 24 weeks was not significantly different between the three groups stratified by randomization or by 24-week FPG levels. While the change in HbA1c from baseline to 24 weeks was slightly higher among participants with baseline FPG-CV < 33.3% (vs. > 66.7%; P = 0.023), a higher proportion of participants with baseline FPG-CV < 33.3% achieved HbA1c < 7% (P = 0.021).

CONCLUSIONS

GV was not associated with either target FPG levels or HbA1c < 7.0% after 24 weeks of treatment with insulin glargine and OADs.

TRIAL REGISTRATION

Clinicaltrials.gov identifier NCT02545842.

摘要

简介

本事后分析研究考察了血糖变异性（GV）与空腹血糖（FPG）目标之间的关系，这些目标用于实现糖化血红蛋白（HbA1c）<7%，以及在中国 2 型糖尿病（T2DM）患者中使用甘精胰岛素和口服抗糖尿病药物（OADs）治疗 24 周后的 HbA1c 水平。该研究来自 BEYOND III FPG GOAL 试验（NCT02545842）。

方法

根据随机分组的三个 FBG 目标（≤5.6mmol/L、≤6.1mmol/L 和 ≤7.0mmol/L），接受甘精胰岛素 100U/mL 治疗的参与者，分析从基线到 24 周时餐后血糖（PPG）波动和 FPG 变异系数（FPG-CV）的平均变化。该研究根据基线 FPG-CV 和 PPG 波动的基线变化，分析了从基线到 24 周时 HbA1c 的变化以及 24 周时达到 HbA1c<7%的参与者比例。

结果

按随机分组或 24 周 FPG 水平分层，三组之间从基线到 24 周时 PPG 波动和 FPG-CV 的变化没有显著差异。虽然与基线 FPG-CV>66.7%的参与者相比，基线 FPG-CV<33.3%的参与者从基线到 24 周时 HbA1c 的变化略高（P=0.023），但基线 FPG-CV<33.3%的参与者中达到 HbA1c<7%的比例更高（P=0.021）。