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甘精胰岛素 300U/mL 可实现血糖控制和低血糖获益,且适用人群为 2 型糖尿病合并轻中度肾功能损害患者。

Glycaemic control and hypoglycaemia benefits with insulin glargine 300 U/mL extend to people with type 2 diabetes and mild-to-moderate renal impairment.

机构信息

Department of Endocrinology and Nutrition, Clínic University of Navarra, Pamplona, Spain.

Department of Diabetology, Endocrinology and Nutrition, Grenoble University Hospital Center, Grenoble, France.

出版信息

Diabetes Obes Metab. 2018 Dec;20(12):2860-2868. doi: 10.1111/dom.13470. Epub 2018 Aug 30.

Abstract

AIM

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).

MATERIALS AND METHODS

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 .

RESULTS

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.

CONCLUSIONS

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.

摘要

目的

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。

材料和方法

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。

结果

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。

结论

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/35ae/6282564/e3e3273921ac/DOM-20-2860-g002.jpg

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