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基线特征对 2 型糖尿病患者每周一次皮下司美格鲁肽疗效的影响:来自中国 SUSTAIN 研究的事后分析。

Impact of baseline characteristics on the efficacy of once-weekly subcutaneous semaglutide among participants with type 2 diabetes: A post hoc analysis of SUSTAIN China.

机构信息

Peking University People's Hospital, Beijing, China.

The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.

出版信息

Diabetes Obes Metab. 2024 Nov;26(11):5312-5324. doi: 10.1111/dom.15888. Epub 2024 Sep 16.

DOI:10.1111/dom.15888
PMID:39279647
Abstract

AIMS

To investigate the impact of baseline characteristics on the efficacy of once-weekly subcutaneous semaglutide 0.5 and 1.0 mg in participants with type 2 diabetes (T2D) from the SUSTAIN China trial.

METHODS

In this post hoc analysis, data for semaglutide 0.5 and 1.0 mg versus sitagliptin 100 mg were analysed in the total (n = 868) and Chinese-only (n = 605) populations. Changes from baseline to end of treatment (EOT) in glycated haemoglobin (HbA1c) and body weight were analysed by baseline age, sex, body mass index, HbA1c, diabetes duration, and homeostatic model assessment of β-cell function (HOMA-β) tertile. Proportions of participants achieving HbA1c <7.0% (53 mmol/mol) by baseline HbA1c, change from baseline to EOT in standard deviation of seven-point self-monitored plasma glucose (SMPG), derived time-in-range (dTIR) of seven-point SMPG at Week 30, and HOMA-β ratio to baseline at Week 30 were assessed for both populations.

RESULTS

In both populations the efficacy of once-weekly subcutaneous semaglutide 0.5 and 1.0 mg versus sitagliptin was not significantly affected by most of the baseline characteristics studied. The proportion of participants achieving the target HbA1c <7% was not affected by baseline HbA1c (p > 0.05). SMPG fluctuation and dTIR indicated less glucose variability in participants treated with semaglutide 0.5 and 1.0 mg versus sitagliptin, and the HOMA-β ratios to baseline at EOT were greater with semaglutide 0.5 and 1.0 mg versus sitagliptin (p < 0.05).

CONCLUSIONS

These results support the effectiveness of once-weekly subcutaneous semaglutide 0.5 and 1.0 mg across a broad range of baseline characteristics, in participants with T2D from SUSTAIN China.

摘要

目的

研究基线特征对 SUSTAIN China 试验中 2 型糖尿病(T2D)患者每周一次皮下注射司美格鲁肽 0.5 和 1.0mg 疗效的影响。

方法

本事后分析对司美格鲁肽 0.5 和 1.0mg 与西格列汀 100mg 的数据在总体人群(n=868)和仅中国人群(n=605)中进行了分析。根据基线年龄、性别、体重指数、糖化血红蛋白(HbA1c)、糖尿病病程和β细胞功能稳态模型评估(HOMA-β)三分位数,分析治疗结束时(EOT)与基线相比 HbA1c 和体重的变化。根据基线 HbA1c、从基线到 EOT 的七点自我监测血浆葡萄糖(SMPG)标准差变化、第 30 周七点 SMPG 可达到时间(dTIR)和第 30 周时 HOMA-β 比值相对于基线,评估了两个人群中达到 HbA1c<7.0%(53mmol/mol)的参与者比例。

结果

在两个人群中,每周一次皮下注射司美格鲁肽 0.5 和 1.0mg 与西格列汀相比,大多数研究的基线特征对其疗效没有显著影响。达到目标 HbA1c<7%的参与者比例不受基线 HbA1c 的影响(p>0.05)。SMPG 波动和 dTIR 表明,与西格列汀相比,接受司美格鲁肽 0.5 和 1.0mg 治疗的参与者血糖变异性更小,并且与西格列汀相比,EOT 时的 HOMA-β 比值相对于基线更高(p<0.05)。

结论

这些结果支持每周一次皮下注射司美格鲁肽 0.5 和 1.0mg 在 SUSTAIN China 试验中具有广泛的基线特征,对 T2D 患者的有效性。

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