Abstract：
OBJECTIVE: The objective of this study was to compare initiation of a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) vs insulin glargine U100 (iGlar) along with gliclazide, exclusively in people of South Asian origin with type 2 diabetes (T2D).
METHODS: The Variability of glucose Assessed in a Randomized trial comparing the Initiation of A Treatment approach with biosimilar basal Insulin analog Or a titratable iGlarLixi combinatioN in type 2 diabetes among South Asian participants (VARIATION 2 SA) trial (ClinicalTrials.gov identifier: NCT03819790) randomized insulin-naïve adults with T2D having glycated hemoglobin (A1C) 7.1% to 11% to initiate either iGlarLixi or iGlar + gliclazide. Insulin doses were titrated similarly to a prebreakfast glucose target of 4.0 to 5.5 mmol/L. Average time in range (TIR) on a masked continuous glucose monitor (CGM), A1C, fasting plasma glucose (FPG) and weight were assessed at the end of the 12-week treatment period.
RESULTS: Mean baseline characteristics for the 104 randomized participants were similar between treatment groups, including the following: age, 59±11 years; diabetes duration, 13.7±7.3 years; and A1C, 8.5%±1.2%. Coprimary outcomes of average TIRs within 24- and 12-h (6 am to 6 pm) periods at the end of trial were 70.5%±16.8% and 72.9%±17.6% for iGlarLixi, whereas these TIRs were 65.6%±21.6% and 67.3%±20.7% for the iGlar + gliclazide regimen, respectively, with no significant differences between groups (p=0.35 for 24-h TIR and p=0.14 for 12-h TIR). No significant difference in secondary outcomes was observed between treatment groups. Self-reported hypoglycemic events throughout the trial period and CGM-reported hypoglycemia (<4 and <3 mmol/L) were similar between randomized treatments.
CONCLUSIONS: Initiation of iGlarLixi resulted in similar TIR, A1C, FPG, weight and hypoglycemia compared with the more affordable option of starting iGlar + gliclazide in adults of South Asian origin with T2D.
METHODS: The Variability of glucose Assessed in a Randomized trial comparing the Initiation of A Treatment approach with biosimilar basal Insulin analog Or a titratable iGlarLixi combinatioN in type 2 diabetes among South Asian participants (VARIATION 2 SA) trial (ClinicalTrials.gov identifier: NCT03819790) randomized insulin-naïve adults with T2D having glycated hemoglobin (A1C) 7.1% to 11% to initiate either iGlarLixi or iGlar + gliclazide. Insulin doses were titrated similarly to a prebreakfast glucose target of 4.0 to 5.5 mmol/L. Average time in range (TIR) on a masked continuous glucose monitor (CGM), A1C, fasting plasma glucose (FPG) and weight were assessed at the end of the 12-week treatment period.
RESULTS: Mean baseline characteristics for the 104 randomized participants were similar between treatment groups, including the following: age, 59±11 years; diabetes duration, 13.7±7.3 years; and A1C, 8.5%±1.2%. Coprimary outcomes of average TIRs within 24- and 12-h (6 am to 6 pm) periods at the end of trial were 70.5%±16.8% and 72.9%±17.6% for iGlarLixi, whereas these TIRs were 65.6%±21.6% and 67.3%±20.7% for the iGlar + gliclazide regimen, respectively, with no significant differences between groups (p=0.35 for 24-h TIR and p=0.14 for 12-h TIR). No significant difference in secondary outcomes was observed between treatment groups. Self-reported hypoglycemic events throughout the trial period and CGM-reported hypoglycemia (<4 and <3 mmol/L) were similar between randomized treatments.
CONCLUSIONS: Initiation of iGlarLixi resulted in similar TIR, A1C, FPG, weight and hypoglycemia compared with the more affordable option of starting iGlar + gliclazide in adults of South Asian origin with T2D.
摘要：
目的：本研究的目的是比较甘精胰岛素和利西拉来（iGlarLixi）与甘精胰岛素U100（iGlar）和格列齐特的固定比例组合的起始，仅在南亚血统的2型糖尿病（T2D）患者中。
方法：在一项随机试验中评估了葡萄糖的变异性，该试验比较了在南亚参与者中2型糖尿病患者中采用生物类似药物基础胰岛素类似物或可滴定的iGlarLixi组合的治疗方法的启动（VARITION2SA）试验（ClinicalTrials.gov标识符：NCT03819790）将胰岛素-nailared成人与T以类似于早餐前葡萄糖目标4.0至5.5mmol/L的方式滴定胰岛素剂量。屏蔽连续葡萄糖监测仪(CGM)的平均时间范围(TIR),A1C,在12周治疗期结束时评估空腹血糖(FPG)和体重.
结果：104名随机参与者的平均基线特征在治疗组之间相似，包括:年龄,59±11年；糖尿病病程，13.7±7.3年；和A1C，8.5%±1.2%。iGlarLixi在试验结束时24小时和12小时（上午6点至下午6点）内的平均TIR的共同主要结果为70.5％±16.8％和72.9％±17.6％，而iGlar+格列齐特方案的TIR分别为65.6%±21.6%和67.3%±20.7%，分别,组间无显著差异(24小时TIRp=0.35，12小时TIRp=0.14)。治疗组之间的次要结局没有显着差异。在整个试验期间自我报告的低血糖事件和CGM报告的低血糖（<4和<3mmol/L）在随机治疗之间相似。
结论：启动iGlarLixi导致类似的TIR，A1C,FPG,与更实惠的选择开始iGlar+格列齐特在南亚血统的成人患有T2D相比，体重和低血糖。
方法：在一项随机试验中评估了葡萄糖的变异性，该试验比较了在南亚参与者中2型糖尿病患者中采用生物类似药物基础胰岛素类似物或可滴定的iGlarLixi组合的治疗方法的启动（VARITION2SA）试验（ClinicalTrials.gov标识符：NCT03819790）将胰岛素-nailared成人与T以类似于早餐前葡萄糖目标4.0至5.5mmol/L的方式滴定胰岛素剂量。屏蔽连续葡萄糖监测仪(CGM)的平均时间范围(TIR),A1C,在12周治疗期结束时评估空腹血糖(FPG)和体重.
结果：104名随机参与者的平均基线特征在治疗组之间相似，包括:年龄,59±11年；糖尿病病程，13.7±7.3年；和A1C，8.5%±1.2%。iGlarLixi在试验结束时24小时和12小时（上午6点至下午6点）内的平均TIR的共同主要结果为70.5％±16.8％和72.9％±17.6％，而iGlar+格列齐特方案的TIR分别为65.6%±21.6%和67.3%±20.7%，分别,组间无显著差异(24小时TIRp=0.35，12小时TIRp=0.14)。治疗组之间的次要结局没有显着差异。在整个试验期间自我报告的低血糖事件和CGM报告的低血糖（<4和<3mmol/L）在随机治疗之间相似。
结论：启动iGlarLixi导致类似的TIR，A1C,FPG,与更实惠的选择开始iGlar+格列齐特在南亚血统的成人患有T2D相比，体重和低血糖。
