目的:比较甘精胰岛素100U/mL加利西拉来(iGlarLixi)与预混胰岛素的固定比例组合的疗效和安全性,degludec胰岛素加门冬胰岛素(IDegAsp),在中国2型糖尿病(T2D)患者中,口服抗糖尿病药物(OADs)控制不佳。
方法:在Soli-D中,24周,多中心,开放标签,study,未接受胰岛素治疗的成年人以1:1的比例随机分配给每天一次注射iGlarLixi(n=291)或IDegAsp(n=291),继续使用二甲双胍±钠-葡萄糖共转运蛋白2抑制剂。主要终点是从基线到第24周的HbA1c变化的非劣效性。关键次要终点包括24周时HbA1c变化和体重(BW)变化的优势。还评估了低血糖发生率。
结果:在第24周,iGlarLixi在HbA1c降低方面显示出非劣性和优于IDegAsp(最小二乘[LS]平均差:-0.20[95%置信区间{CI}:-0.33,-0.07];非劣性P<.001;[97.5%CI:-0.35,-0.05];优越性P=.003)从基线至第24周,iGlarLixi降低了BW,IDegAsp增加了BW,具有统计学意义的LS平均差异-1.49kg,有利于iGlarLixi(97.5%CI:-2.32,-0.66;P<.001)。美国糖尿病协会(ADA)1、2或3级低血糖的事件发生率(每人每年)iGlarLixi(1.90)低于IDegAsp(2.72)(相对风险:0.71;95%CI:0.52,0.98)。未报告ADA3级低血糖或意外安全性发现。
结论:在使用OAD的T2D亚最优控制的中国人中,与IDegAsp相比,每天1次iGlarLixi可更好地控制血糖,同时可获益于BW,并降低低血糖事件发生率.
OBJECTIVE: To compare the efficacy and safety of a fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) with premixed insulin, insulin degludec plus insulin aspart (IDegAsp), in Chinese people with type 2 diabetes (T2D) suboptimally controlled with oral antidiabetic drug(s) (OADs).
METHODS: In Soli-D, a 24-week, multicentre, open-label, study, insulin-naïve adults were randomized 1:1 to once-daily injections of iGlarLixi (n = 291) or IDegAsp (n = 291), with continued metformin ± sodium-glucose co-transporter-2 inhibitors. The primary endpoint was non-inferiority in HbA1c change from baseline to week 24. Key secondary endpoints included superiority in HbA1c change and body weight (BW) change at week 24. Hypoglycaemia rates were also assessed.
RESULTS: At week 24, iGlarLixi showed non-inferiority and superiority over IDegAsp in HbA1c reduction (least squares [LS] mean difference: -0.20 [95% confidence interval {CI}: -0.33, -0.07]; P < .001 for non-inferiority; [97.5% CI: -0.35, -0.05]; P = .003 for superiority). iGlarLixi decreased BW and IDegAsp increased BW from baseline to week 24, with a statistically significant LS mean difference of -1.49 kg in favour of iGlarLixi (97.5% CI: -2.32, -0.66; P < .001). Event rates (per person-year) for American Diabetes Association (ADA) Level 1, 2 or 3 hypoglycaemia were lower for iGlarLixi (1.90) versus IDegAsp (2.72) (relative risk: 0.71; 95% CI: 0.52, 0.98). No ADA Level 3 hypoglycaemia or unexpected safety findings were reported.
CONCLUSIONS: In Chinese people with T2D suboptimally controlled with OADs, once-daily iGlarLixi provided better glycaemic control with BW benefit and lower hypoglycaemia event rates versus IDegAsp.