Abstract：
To evaluate the efficacy of iGlarLixi in the Asian Pacific (AP) population with type 2 diabetes (T2D) using derived time-in-ranges calculated from seven-point self-measured blood glucose.
Two phase III trials were analysed. LixiLan-O-AP was performed in insulin-naive T2D patients (n = 878) randomized to iGlarLixi, glargine 100 units/mL (iGlar) or lixisenatide (Lixi). LixiLan-L-CN was performed in insulin-treated T2D patients (n = 426) randomized to iGlarLixi or iGlar. Changes in derived time-in-ranges from baseline to end-of-treatment (EOT) and estimated treatment differences (ETDs) were analysed. The proportions of patients achieving 70% or higher derived time-in-range (dTIR), 5% or higher dTIR improvement, and the composite triple target (≥ 70% dTIR, < 4% derived time-below-the-range [dTBR] and < 25% derived time-above-the-range [dTAR]) were calculated.
The changes from baseline to EOT in dTIR with iGlarLixi were greater versus iGlar (ETD1 : 11.45% [95% CI, 7.66% to 15.24%]) or Lixi (ETD2 : 20.54% [95% CI, 15.74% to 25.33%]) in LixiLan-O-AP, and versus iGlar (ETD: 16.59% [95% CI, 12.09% to 21.08%]) in LixiLan-L-CN. In LixiLan-O-AP, the proportions of patients achieving 70% or higher dTIR or 5% or higher dTIR improvement at EOT with iGlarLixi were 77.5% and 77.8%, respectively, higher than with iGlar (61.1% and 75.3%) or Lixi (47.0% and 53.0%). In LixiLan-L-CN, the proportions of patients achieving 70% or higher dTIR or 5% or higher dTIR improvement at EOT were 71.4% and 59.8% with iGlarLixi, greater than with iGlar (45.4% and 39.5%). More patients achieved the triple target with iGlarLixi compared with iGlar or Lixi.
iGlarLixi achieved greater improvements in dTIR parameters versus iGlar or Lixi in insulin-naïve and insulin-experienced AP people with T2D.
Two phase III trials were analysed. LixiLan-O-AP was performed in insulin-naive T2D patients (n = 878) randomized to iGlarLixi, glargine 100 units/mL (iGlar) or lixisenatide (Lixi). LixiLan-L-CN was performed in insulin-treated T2D patients (n = 426) randomized to iGlarLixi or iGlar. Changes in derived time-in-ranges from baseline to end-of-treatment (EOT) and estimated treatment differences (ETDs) were analysed. The proportions of patients achieving 70% or higher derived time-in-range (dTIR), 5% or higher dTIR improvement, and the composite triple target (≥ 70% dTIR, < 4% derived time-below-the-range [dTBR] and < 25% derived time-above-the-range [dTAR]) were calculated.
The changes from baseline to EOT in dTIR with iGlarLixi were greater versus iGlar (ETD1 : 11.45% [95% CI, 7.66% to 15.24%]) or Lixi (ETD2 : 20.54% [95% CI, 15.74% to 25.33%]) in LixiLan-O-AP, and versus iGlar (ETD: 16.59% [95% CI, 12.09% to 21.08%]) in LixiLan-L-CN. In LixiLan-O-AP, the proportions of patients achieving 70% or higher dTIR or 5% or higher dTIR improvement at EOT with iGlarLixi were 77.5% and 77.8%, respectively, higher than with iGlar (61.1% and 75.3%) or Lixi (47.0% and 53.0%). In LixiLan-L-CN, the proportions of patients achieving 70% or higher dTIR or 5% or higher dTIR improvement at EOT were 71.4% and 59.8% with iGlarLixi, greater than with iGlar (45.4% and 39.5%). More patients achieved the triple target with iGlarLixi compared with iGlar or Lixi.
iGlarLixi achieved greater improvements in dTIR parameters versus iGlar or Lixi in insulin-naïve and insulin-experienced AP people with T2D.
摘要：
目的：使用从七点自测血糖计算得出的时间范围，评估iGlarLixi在亚太地区（AP）2型糖尿病（T2D）人群中的疗效。
方法：分析了两项III期试验。LixiLan-O-AP在未接受胰岛素治疗的T2D患者（n=878）中进行，随机分为iGlarLixi，甘精100单位/mL（iGlar）或利西拉来（Lixi）。在接受胰岛素治疗的T2D患者（n=426）中进行了LixiLan-L-CN，随机分为iGlarLixi或iGlar。分析了从基线到治疗结束（EOT）的衍生时间范围变化和估计的治疗差异（ETD）。达到70%或更高的衍生时间范围（dTIR）的患者比例，5%或更高的dTIR改进，和复合三重目标(≥70%dTIR，计算<4%的衍生时间低于范围[dTBR]和<25%的衍生时间高于范围[dTAR])。
结果：在LixiLan-O-AP中，使用iGlarLixi的dTIR从基线到EOT的变化大于iGlar（ETD1：11.45%[95%CI，7.66%至15.24%]）或Lixi（ETD2：20.54%[95%CI，15.74%至25.33%]），和iGlar（ETD：16.59%[95%CI，12.09%至21.08%]）在LixiLan-L-CN中。在LixiLan-O-AP,在使用iGlarLixi的EOT时达到70%或更高dTIR或5%或更高dTIR改善的患者比例分别为77.5%和77.8%，分别,高于iGlar（61.1%和75.3%）或Lixi（47.0%和53.0%）。在LixiLan-L-CN,在EOT达到70%或更高dTIR或5%或更高dTIR改善的患者比例分别为71.4%和59.8%，高于iGlar（45.4%和39.5%）。与iGlar或Lixi相比，更多的患者使用iGlarLixi实现了三重目标。
结论：iGlarLixi与iGlar或Lixi相比，在初治胰岛素和有胰岛素经验的AP患者的T2D患者中，dTIR参数有更大的改善。
方法：分析了两项III期试验。LixiLan-O-AP在未接受胰岛素治疗的T2D患者（n=878）中进行，随机分为iGlarLixi，甘精100单位/mL（iGlar）或利西拉来（Lixi）。在接受胰岛素治疗的T2D患者（n=426）中进行了LixiLan-L-CN，随机分为iGlarLixi或iGlar。分析了从基线到治疗结束（EOT）的衍生时间范围变化和估计的治疗差异（ETD）。达到70%或更高的衍生时间范围（dTIR）的患者比例，5%或更高的dTIR改进，和复合三重目标(≥70%dTIR，计算<4%的衍生时间低于范围[dTBR]和<25%的衍生时间高于范围[dTAR])。
结果：在LixiLan-O-AP中，使用iGlarLixi的dTIR从基线到EOT的变化大于iGlar（ETD1：11.45%[95%CI，7.66%至15.24%]）或Lixi（ETD2：20.54%[95%CI，15.74%至25.33%]），和iGlar（ETD：16.59%[95%CI，12.09%至21.08%]）在LixiLan-L-CN中。在LixiLan-O-AP,在使用iGlarLixi的EOT时达到70%或更高dTIR或5%或更高dTIR改善的患者比例分别为77.5%和77.8%，分别,高于iGlar（61.1%和75.3%）或Lixi（47.0%和53.0%）。在LixiLan-L-CN,在EOT达到70%或更高dTIR或5%或更高dTIR改善的患者比例分别为71.4%和59.8%，高于iGlar（45.4%和39.5%）。与iGlar或Lixi相比，更多的患者使用iGlarLixi实现了三重目标。
结论：iGlarLixi与iGlar或Lixi相比，在初治胰岛素和有胰岛素经验的AP患者的T2D患者中，dTIR参数有更大的改善。
