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.
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。