在基础胰岛素治疗的2型糖尿病控制不佳患者中推进治疗：SoliMix随机对照试验中甘精胰岛素利司那肽与预混门冬胰岛素30的临床结局
Advancing Therapy in Suboptimally Controlled Basal Insulin-Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial.
作者信息
Rosenstock Julio, Emral Rifat, Sauque-Reyna Leobardo, Mohan Viswanathan, Trescolí Carlos, Al Sifri Saud, Lalic Nebojsa, Alvarez Agustina, Picard Pascaline, Bonnemaire Mireille, Demil Nacima, McCrimmon Rory J
机构信息
Dallas Diabetes Research Center at Medical City, Dallas, TX
Department of Endocrinology and Metabolic Diseases, Ankara University Faculty of Medicine, Ankara, Turkey.
出版信息
Diabetes Care. 2021 Jun 28;44(10):2361-70. doi: 10.2337/dc21-0393.
OBJECTIVE
To directly compare the efficacy and safety of a fixed-ratio combination, of insulin glargine 100 units/mL and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi), with those of a premix insulin analog, biphasic aspart insulin 30 (30% insulin aspart and 70% insulin aspart protamine) (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs).
RESEARCH DESIGN AND METHODS
In SoliMix, a 26-week, open-label, multicenter study, adults with suboptimally controlled basal insulin-treated type 2 diabetes (HbA ≥7.5% and ≤10%) were randomized to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy end points were noninferiority in HbA reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30.
RESULTS
Both primary efficacy end points were met: after 26 weeks, baseline HbA (8.6%) was reduced by 1.3% with iGlarLixi and 1.1% with BIAsp 30, meeting noninferiority (least squares [LS] mean difference -0.2% [97.5% CI -0.4, -0.1]; < 0.001). iGlarLixi was also superior to BIAsp 30 for body weight change (LS mean difference -1.9 kg [95% CI -2.3, -1.4]) and percentage of participants achieving HbA <7% without weight gain and HbA <7% without weight gain and without hypoglycemia (all < 0.001). iGlarLixi was also superior versus BIAsp 30 for HbA reduction ( < 0.001). Incidence and rates of American Diabetes Association level 1 and 2 hypoglycemia were lower with iGlarLixi versus BIAsp 30.
CONCLUSIONS
Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia than twice-daily premix BIAsp 30. iGlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 in suboptimally controlled type 2 diabetes requiring treatment beyond basal insulin plus OAD therapy. VIDEO 1: diacare;dc21-0393v4/F1F1f1Infographic available at https://care.diabetesjournals.org/content/dc21-0393-infographic.
目的
直接比较甘精胰岛素100单位/毫升与胰高血糖素样肽-1受体激动剂利司那肽的固定比例复方制剂（iGlarLixi）和预混胰岛素类似物双相门冬胰岛素30（30%门冬胰岛素和70%精蛋白门冬胰岛素）（BIAsp 30）作为基础胰岛素加口服降糖药（OADs）治疗效果欠佳的2型糖尿病患者治疗升级方案时的疗效和安全性。
研究设计与方法
在一项为期26周的开放标签、多中心研究SoliMix中，基础胰岛素治疗效果欠佳的2型糖尿病成人患者（糖化血红蛋白[HbA]≥7.5%且≤10%）被随机分为每日一次的iGlarLixi组或每日两次的BIAsp 30组。主要疗效终点为iGlarLixi组与BIAsp 30组相比，HbA降低的非劣效性（界值0.3%）或体重变化的优效性。
结果
两个主要疗效终点均达到：26周后，iGlarLixi组基线HbA（8.6%）降低了1.3%，BIAsp 30组降低了1.1%，达到非劣效性（最小二乘法[LS]均值差异-0.2%[97.5%CI -0.4，-0.1]；P<0.001）。iGlarLixi组在体重变化方面也优于BIAsp 30组（LS均值差异-1.9千克[95%CI -2.3，-1.4]），以及在未体重增加且HbA<7%和未体重增加且未发生低血糖的参与者百分比方面（均P<0.001）。iGlarLixi组在HbA降低方面也优于BIAsp 30组（P<0.001）。与BIAsp 30组相比，iGlarLixi组美国糖尿病协会1级和2级低血糖的发生率和发生率更低。
结论
每日一次的iGlarLixi与每日两次的预混BIAsp 30相比，能提供更好的血糖控制，有益体重且低血糖更少。在基础胰岛素加OAD治疗效果欠佳、需要进一步治疗的2型糖尿病患者中，iGlarLixi是一种比预混BIAsp 30更有效、更简便且耐受性良好的替代方案。视频1：diacare；dc21 - 0393v4/F1F1f1信息图可在https://care.diabetesjournals.org/content/dc21 - 0393 - infographic获取。
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