Department of Endocrinology and Nutrition, Clínic University of Navarra, Pamplona, Spain.
Department of Diabetology, Endocrinology and Nutrition, Grenoble University Hospital Center, Grenoble, France.
Diabetes Obes Metab. 2018 Dec;20(12):2860-2868. doi: 10.1111/dom.13470. Epub 2018 Aug 30.
To investigate the impact of renal function on the safety and efficacy of insulin glargine 300 U/mL (Gla-300) and insulin glargine 100 U/mL (Gla-100).
A meta-analysis was performed using pooled 6-month data from the EDITION 1, 2 and 3 trials (N = 2496). Eligible participants, aged ≥18 years with a diagnosis of type 2 diabetes (T2DM), were randomized to receive once-daily evening injections of Gla-300 or Gla-100. Pooled results were assessed by two renal function subgroups: estimated glomerular filtration rate (eGFR) <60 and ≥60 mL/min/1.73 m .
The decrease in glycated haemoglobin (HbA1c) after 6 months and the proportion of individuals with T2DM achieving HbA1c targets were similar in the Gla-300 and Gla-100 groups, for both renal function subgroups. There was a reduced risk of nocturnal (12:00-5:59 am) confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia with Gla-300 in both renal function subgroups (eGFR <60 mL/min/1.73 m : relative risk [RR] 0.76 [95% confidence interval {CI} 0.62-0.94] and eGFR ≥60 mL/min/1.73 m : RR 0.75 [95% CI 0.67-0.85]). For confirmed (≤70 mg/dL [≤3.9 mmol/L]) or severe hypoglycaemia at any time of day (24 hours) the hypoglycaemia risk was lower with Gla-300 vs Gla-100 in both the lower (RR 0.94 [95% CI 0.86-1.03]) and higher (RR 0.90 [95% CI 0.85-0.95]) eGFR subgroups.
Gla-300 provided similar glycaemic control to Gla-100, while indicating a reduced overall risk of confirmed (≤3.9 and <3.0 mmol/L [≤70 and <54 mg/dL]) or severe hypoglycaemia, with no significant difference between renal function subgroups.
探讨肾功能对胰岛素甘精 300U/ml(Gla-300)和胰岛素甘精 100U/ml(Gla-100)安全性和疗效的影响。
使用 EDITION 1、2 和 3 项试验的 6 个月汇总数据进行荟萃分析(N=2496)。纳入年龄≥18 岁、诊断为 2 型糖尿病(T2DM)的合格参与者,随机接受每晚一次皮下注射 Gla-300 或 Gla-100。通过两个肾功能亚组评估汇总结果:估计肾小球滤过率(eGFR)<60 和≥60mL/min/1.73m2。
在肾功能亚组中,6 个月后糖化血红蛋白(HbA1c)的下降以及达到 HbA1c 目标的 T2DM 个体比例在 Gla-300 和 Gla-100 组中相似。在两个肾功能亚组中,Gla-300 均降低了夜间(12:00-5:59 am)确诊(≤3.9mmol/L[≤70mg/dL])或严重低血糖的风险(eGFR<60mL/min/1.73m:相对风险[RR]0.76[95%置信区间{CI}0.62-0.94]和 eGFR≥60mL/min/1.73m:RR0.75[95%CI0.67-0.85])。对于任何时间点(24 小时)的确诊(≤70mg/dL[≤3.9mmol/L])或严重低血糖,Gla-300 与 Gla-100 相比,在较低(RR0.94[95%CI0.86-1.03])和较高(RR0.90[95%CI0.85-0.95])eGFR 亚组中,低血糖风险均较低。
Gla-300 提供了与 Gla-100 相似的血糖控制效果,同时表明总体上确诊(≤3.9 和<3.0mmol/L[≤70 和<54mg/dL])或严重低血糖的风险降低,肾功能亚组之间无显著差异。