甘精胰岛素300 U/ml与100 U/ml治疗中国2型糖尿病患者疗效和安全性的比较

Efficacy and safety of insulin glargine 300 U/ml versus insulin glargine 100 U/ml in Chinese patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drugs

目的比较甘精胰岛素300 U/ml(Gla-300)与100 U/ml(Gla-100)治疗非胰岛素类降糖药血糖控制不佳中国T2DM患者的疗效和安全性。方法本研究为EDITION AP(NCT02855684)中国亚组分析,在这项开放标签、随机对照的临床试验中,非Ins类降糖药物血糖控制不佳的474例中国T2DM患者按2:1比例随机予Gla-300(n=315)或Gla-100(n=159)治疗,观察两组26周时的疗效和安全性指标。结果两组自基线至治疗26周时HbA1c降幅的最小二乘均值差为0.05%,达到非劣效性评估终点。26周治疗期间,Gla-300组发生至少1次重度和/或证实夜间低血糖患者比例低于Gla-100组(31.5%vs 42.0%,P=0.03)。两组其余疗效和安全性指标差异无统计学意义。结论Gla-300治疗26周降低HbA1c效果与Gla-100相似,发生夜间低血糖风险更低。

Objective To compare the efficacy and safety of insulin glargine 300 U/ml(Gla-300)versus insulin glargine 100 U/ml(Gla-100) in insulin-naive Chinese adult patients with type 2 diabetes mellitus(T2DM).Methods EDITION AP(NCT02855684) was an open-label,randomized, active-controlled,26-week study.In this Chinese subgroup analysis, 474 insulin-naive Chinese mainland participants with T2DM inadequately controlled with non-insulin antihyperglycemic drugs were randomized(2:1) to Gla-300(n=315) or Gla-100(n=159) group.Results Non-inferiority of two groups in HbA1c reduction from baseline to week 26 was confirmed with least squares mean difference of 0.05%.During 26-week treatment,fewer patients reported≥1 nocturnal severe or confirmed hypoglycemia with Gla-300 than Gla-100(31.5%vs 42.0%, P=0.03).Other efficacy and safety profile endpoints were similar between groups.Conclusion Gla-300 is non-inferior to Gla-100 in reducing HbA1c over 26 weeks in insulin-naive Chinese patients with T2DM, with lower nocturnal hypoglycemia risk.