Diabetes, obesity & metabolism · 2026
Impact of iGlarLixi on Glycaemic Control Depth and Variability in Asian Pacific People With Type 2 Diabetes: A Post Hoc Analysis of LixiLan-O-AP and LixiLan-L-CN.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Ni Jiaying, Lu Jingyi, Gao Fei, Li Min, Zhang Minlu, Du Qin, Kang Lei, Peng Danfeng, Zhou Jian
Аннотация
AIMS: To evaluate the impact of iGlarLixi on the depth of glycaemic control, glycaemic variability (GV) and postprandial glucose (PPG) control versus insulin glargine 100 U/mL (iGlar) or lixisenatide (Lixi) in Asian Pacific individuals with type 2 diabetes (T2D).
MATERIALS AND METHODS: A post hoc analysis was conducted of two phase 3 trials in individuals with suboptimally controlled T2D on oral antidiabetic drugs (LixiLan-O-AP) or basal insulin (LixiLan-L-CN). Outcomes were evaluated from baseline to end-of-treatment (EOT; Week 24 or 30, respectively). Using self-monitoring of blood glucose (SMBG) profiles, glycaemic control depth was assessed via derived time in tight range (dTITR; 3.9-7.8 mmol/L). GV was evaluated using standard deviation (SD) of SMBG, high blood glucose index (HBGI), mean absolute glucose (MAG), and mean amplitude of glycaemic excursions (MAGE). PPG at 0.5, 1, and 2 h was measured via standardised meal tests.
RESULTS: From baseline to EOT, iGlarLixi provided greater increases in dTITR versus iGlar (least squares mean difference 15.03%) or Lixi (29.14%) in LixiLan-O-AP, and versus iGlar (15.93%) in LixiLan-L-CN. At EOT, > 50% dTITR rate was 67.2%, 41.1% and 26.5% with iGlarLixi, iGlar and Lixi in LixiLan-O-AP, respectively, and 53.6% and 26.4% with iGlarLixi and iGlar in LixiLan-L-CN. iGlarLixi provided generally greater reductions in SD of SMBG, HBGI, MAG, MAGE and 0.5-, 1- and 2-h PPG versus iGlar or Lixi and greater 2-h PPG < 10.0 mmol/L achievement rates at EOT.
CONCLUSION: iGlarLixi improves dTITR, GV, and PPG control versus iGlar or Lixi in Asian Pacific individuals with T2D.
MATERIALS AND METHODS: A post hoc analysis was conducted of two phase 3 trials in individuals with suboptimally controlled T2D on oral antidiabetic drugs (LixiLan-O-AP) or basal insulin (LixiLan-L-CN). Outcomes were evaluated from baseline to end-of-treatment (EOT; Week 24 or 30, respectively). Using self-monitoring of blood glucose (SMBG) profiles, glycaemic control depth was assessed via derived time in tight range (dTITR; 3.9-7.8 mmol/L). GV was evaluated using standard deviation (SD) of SMBG, high blood glucose index (HBGI), mean absolute glucose (MAG), and mean amplitude of glycaemic excursions (MAGE). PPG at 0.5, 1, and 2 h was measured via standardised meal tests.
RESULTS: From baseline to EOT, iGlarLixi provided greater increases in dTITR versus iGlar (least squares mean difference 15.03%) or Lixi (29.14%) in LixiLan-O-AP, and versus iGlar (15.93%) in LixiLan-L-CN. At EOT, > 50% dTITR rate was 67.2%, 41.1% and 26.5% with iGlarLixi, iGlar and Lixi in LixiLan-O-AP, respectively, and 53.6% and 26.4% with iGlarLixi and iGlar in LixiLan-L-CN. iGlarLixi provided generally greater reductions in SD of SMBG, HBGI, MAG, MAGE and 0.5-, 1- and 2-h PPG versus iGlar or Lixi and greater 2-h PPG < 10.0 mmol/L achievement rates at EOT.
CONCLUSION: iGlarLixi improves dTITR, GV, and PPG control versus iGlar or Lixi in Asian Pacific individuals with T2D.