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与胰岛素lispro相比,超快速lispro在患有1型糖尿病的中国患者中改善了食后血糖控制:一项前性,随机化,双盲的第三期研究
Jianhua Ma1, Xiang Yan2, Qiong Feng2
1Department of Endocrinology, Nanjing First Hospital, Nanjing, China.
Diabetes, obesity & metabolism
|October 23, 2023
概括
超快速利斯普罗 (URLi) 在控制食后葡萄糖外流方面表现优越,与中国1型糖尿病患者的胰岛素利斯普罗相比. 此外,URLi在整体血糖控制 (HbA1c) 中也表现出非劣势,具有类似的安全性.
科学领域:
- 内分泌学和新陈代谢学
- 药理学和制药科学 药理学和制药科学
背景情况:
- 1型糖尿病 (T1D) 的管理需要有效的血糖控制策略.
- 超快速作用胰岛素的目的是改善食后血糖 (PPG) 控制和改善患者的舒适性.
研究的目的:
- 与胰岛素lispro相比,评估超快速lispro (URLi) 的疗效和安全性.
- 主要目标:评估URLi与胰岛素lispro在血糖控制 (HbA1c) 中的非劣势性.
- 二级目标:评估URLi在减少PPG游览方面的优势.
主要方法:
- 前性,随机,双盲,治疗到目标,第三阶段研究.
- 参与者:主要是中国T1D患者.
- 干预:患者随机分配给URLi (n=176) 或胰岛素利斯普罗 (n=178) 在基础胰岛素优化后的基础玻尿素治疗方案中.
主要成果:
- 从基线到第26周的HbA1c降低为URLi的-0.21%和胰岛素利斯普罗的-0.28% (非劣质发现).
- 在减少1小时 (p<0.005) 和2小时 (p<0.005) 的PPG游览方面,URLi表现出了统计学上显著的优势.
- URLi和胰岛素利斯普罗的安全性概况是可比的.
结论:
- 在主要是中国T1D患者的HbA1c控制中,URLi与胰岛素lispro无差.
- 在控制食后葡萄糖外流方面,URLi显示出优越性.
- 在这种人群中,URLi代表了一种安全有效的葡萄糖管理替代方案.
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