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基础胰岛素与胰高血糖素样肽-1 受体激动剂固定比例复方制剂治疗日本 2 型糖尿病患者:复杂治疗挑战的创新性解决方案。

Fixed-ratio combination of basal insulin and glucagon-like peptide-1 receptor agonists in the treatment of Japanese people with type 2 diabetes: An innovative solution to a complex therapeutic challenge.

机构信息

Division of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, Kurashiki, Japan.

Medical Affairs, Sanofi, Tokyo, Japan.

出版信息

Diabetes Obes Metab. 2020 Sep;22 Suppl 4:24-34. doi: 10.1111/dom.14095.

Abstract

Over 10 million people in Japan have known or suspected type 2 diabetes (T2D), and this number is expected to rise. Although many people require therapy escalation because of the progressive nature of T2D, this appears to be suboptimal in Japanese real-world clinical practice. Insulin therapy tends to be introduced only when glycaemic control is very poor (mean glycated haemoglobin >9%). Although basal insulin therapy is effective in reducing fasting plasma glucose (FPG), postprandial plasma glucose often remains uncontrolled. Basal-bolus insulin regimens are complex and carry the risk of weight gain and hypoglycaemia. Recently, fixed-ratio combinations (FRCs) of BI and glucagon-like peptide-1 receptor agonists (GLP-1RAs) have shown efficacy in reducing both FPG and postprandial plasma glucose with a single injection and without increased risk of hypoglycaemia or weight gain. IDegLira, a titratable FRC of insulin degludec (100 U/mL) and liraglutide, is currently available in Japan and the United States/European Union at a ratio of 1 U (unit):0.036 mg. iGlarLixi (insulin glargine 100 U/mL and lixisenatide at a ratio of 1:1 (20 U/20 μg) has recently been approved in Japan. Phase 3 trials in Japan for IDegLira (DUAL Japan) and iGlarLixi (LixiLan JP) have shown that both FRCs are efficacious. This review provides an overview of IDegLira and iGlarLixi (Japanese formulation) and considers their potential use as new therapeutic options to address the clinical need for early glycaemic control in Japanese people with T2D.

摘要

在日本,超过 1000 万人已知或疑似患有 2 型糖尿病(T2D),且这一数字预计还会上升。尽管许多人因 T2D 的进展性而需要升级治疗,但在日本的实际临床实践中,这种情况似乎并不理想。胰岛素治疗往往仅在血糖控制非常差(平均糖化血红蛋白>9%)时才开始。虽然基础胰岛素治疗可有效降低空腹血糖(FPG),但餐后血糖往往仍不受控制。基础-餐时胰岛素方案复杂,且存在体重增加和低血糖的风险。最近,双胰岛素和胰高血糖素样肽-1 受体激动剂(GLP-1RA)的固定比例组合(FRCs)显示出单次注射即可降低 FPG 和餐后血糖的疗效,且不会增加低血糖或体重增加的风险。IDegLira 是一种可滴定的胰岛素地特胰岛素(100U/mL)和利拉鲁肽 FRC,目前在日本和美国/欧盟以 1U(单位):0.036mg 的比例上市。iGlarLixi(胰岛素甘精 100U/mL 和利西那肽比例为 1:1(20U/20μg))最近在日本获得批准。IDegLira(DUAL Japan)和 iGlarLixi(LixiLan JP)在日本的 3 期临床试验表明,这两种 FRC 均有效。本文综述了 IDegLira 和 iGlarLixi(日本制剂),并探讨了它们作为新的治疗选择在日本 T2D 人群中早期控制血糖的潜在用途。

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