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比较甘精胰岛素 300U/ml(特充)与甘精胰岛素 100U/ml 在 2 型糖尿病和 1 型糖尿病中的临床疗效和安全性:系统文献回顾和荟萃分析。

Comparative clinical efficacy and safety of insulin glargine 300 U/ml (Toujeo) versus insulin glargine 100 U/ml in type 2 diabetes and type 1 diabetes: A systematic literature review and meta-analysis.

机构信息

Department of Diabetology and Endocrinology, Lilavati Hospital and Research Center, Mumbai, India.

Clinical Development and Medical Affairs, Biocon Biologics India Ltd., Bengaluru, India.

出版信息

Diabetes Obes Metab. 2023 Jun;25(6):1589-1606. doi: 10.1111/dom.15007. Epub 2023 Feb 28.

Abstract

AIM

To compare the clinical efficacy and safety of glargine-U100 (Lantus/Gla-100) with glargine-U300 (Toujeo/Gla-300) in adult patients with type 2 diabetes (T2D) and type 1 diabetes (T1D).

MATERIALS AND METHODS

A literature search on Gla-300/Gla-100 in diabetes management was conducted using the MEDLINE/Embase/Cochrane databases from inception to 10 January 2021. Eligible studies considered for inclusion were parallel-design, randomized controlled trials (RCTs). The Cochrane risk-of-bias tool was used to evaluate the quality of the included studies. The random-effects model was applied for interpretation of the results.

RESULTS

Of 5348 records screened, 592 were assessed for eligibility and 15 RCTs were considered for data extraction and meta-analysis (T2D [N = 10; n = 7082]; T1D [N = 5; n = 2222]). In patients with T1D, all safety parameters were comparable between Gla-100 and Gla-300. In T2D, statistically significant differences were observed in favour of Gla-300 over Gla-100 for nocturnal and total hypoglycaemia. For efficacy parameters, a statistically and clinically significant difference favouring Gla-100 in basal insulin dose requirement was observed for both T2D and T1D. Change in HbA1c showed a statistically but not clinically significant reduction with Gla-100 compared with Gla-300 in T1D. Statistically significant but clinically less relevant differences favoured Gla-300 for control of body weight in T1D and T2D and Gla-100 for fasting blood glucose in T2D.

CONCLUSIONS

Gla-100 and Gla-300 had comparable efficacy and safety profiles in both T1D and T2D populations. Gla-300 showed a lower risk of nocturnal and total hypoglycaemia, significant in insulin-experienced/exposed patients with T2D. Patients on Gla-300 required significantly more units of insulin daily than the Gla-100 group to achieve equivalent efficacy.

摘要

目的

比较甘精胰岛素 U100(Lantus/Gla-100)与甘精胰岛素 U300(Toujeo/Gla-300)在 2 型糖尿病(T2D)和 1 型糖尿病(T1D)成年患者中的临床疗效和安全性。

材料和方法

使用 MEDLINE/Embase/Cochrane 数据库,从建库至 2021 年 1 月 10 日,对甘精胰岛素 U300/Gla-300 治疗糖尿病的文献进行检索。纳入的研究为平行设计、随机对照试验(RCT)。使用 Cochrane 偏倚风险工具评估纳入研究的质量。采用随机效应模型解释结果。

结果

在筛选的 5348 条记录中,有 592 条被评估为符合纳入标准,15 项 RCT 被纳入数据提取和荟萃分析(T1D[N=5;n=2222];T2D[N=10;n=7082])。在 T1D 患者中,甘精胰岛素 U100 和 U300 的所有安全性参数均无差异。在 T2D 患者中,甘精胰岛素 U300 夜间和总低血糖发生率显著低于甘精胰岛素 U100。对于疗效参数,T2D 和 T1D 患者中,甘精胰岛素 U300 的基础胰岛素剂量需求显著低于甘精胰岛素 U100。T1D 患者中,甘精胰岛素 U100 组的糖化血红蛋白(HbA1c)较甘精胰岛素 U300 组有统计学意义的降低,但无临床意义。T1D 和 T2D 患者中,甘精胰岛素 U300 组的体重控制有统计学意义但临床意义较小的差异,T2D 患者中,甘精胰岛素 U100 组的空腹血糖有统计学意义但临床意义较小的差异。

结论

甘精胰岛素 U100 和 U300 在 T1D 和 T2D 人群中的疗效和安全性相似。在 T2D 胰岛素经验/暴露患者中,甘精胰岛素 U300 夜间和总低血糖风险较低。使用甘精胰岛素 U300 的患者每天需要使用更多单位的胰岛素才能达到等效疗效。

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