中国 2 型糖尿病患者每两周服用一次辅非格列汀的疗效和安全性：一项随机、双盲、安慰剂对照的 3 期试验。

IF 5.4 2区医学 Q1 ENDOCRINOLOGY & METABOLISM Diabetes, Obesity & Metabolism Pub Date : 2024-10-21 DOI:10.1111/dom.16014

Leili Gao, Fang Bian, Tianrong Pan, Hongwei Jiang, Bo Feng, Chengxia Jiang, Jia Sun, Jianzhong Xiao, Pangke Yan, Linong Ji

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引用次数: 0

摘要

目的：我们在中国开展了一项多中心、随机3期试验，评估新型长效二肽基肽酶-4抑制剂--复格列汀(HSK7653)在药物治疗无效的2型糖尿病(T2D)患者中的疗效和安全性：将控制不佳的 T2D 患者随机（1:1:1）分配到复格列汀 10 毫克、复格列汀 25 毫克或安慰剂，每两周口服一次，双盲期 24 周。随后，符合条件的患者在为期28周的开放标签延长期中接受25毫克的复格列汀治疗。主要终点是糖化血红蛋白（HbA1c）从基线到第24周的变化：共有475名患者（中位年龄：54.0岁）接受了随机治疗，并至少接受了一剂辅格列汀10毫克（158人）、辅格列汀25毫克（158人）或安慰剂（159人）；401名患者参加了开放标签延长期治疗。第 24 周时，与安慰剂相比，辅格列汀 10 mg 和辅格列汀 25 mg HbA1c 的最小二乘法（LS）平均差（95% 置信区间 [CI]）分别为-0.63% (-0.81, -0.46)和-0.59% (-0.77, -0.42)（在研究结束时，给予开放标签辅格列汀 25 mg 延长 28 周的患者与基线相比的 p 1c 均保持不变：辅格列汀 10 mg：-0.86% (0.07, -0.86)；辅格列汀 25 mg：-0.77% (0.07, -0.42)）：-0.86%（0.07）；25 毫克：-0.74%（0.07）：-安慰剂：-0.89% (0.07)。在整个研究过程中，常见的不良反应包括高尿酸血症、高脂血症、高甘油三酯血症、脂肪酶升高、上呼吸道感染和尿路感染。各组之间的低血糖事件差异不大：结论：52周内，辅格列汀可控制血糖，T2D患者的耐受性普遍良好：已在 Clinicaltrials.gov 注册，注册号为 NCT04556851 (https://clinicaltrials.gov/study/NCT04556851)。

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Efficacy and safety of cofrogliptin once every 2 weeks in Chinese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled, phase 3 trial.

Aim: We conducted a multicentre, randomized phase 3 trial in China to evaluate the efficacy and safety of cofrogliptin (HSK7653), a novel long-acting dipeptidyl peptidase-4 inhibitor, in patients with drug-naïve type 2 diabetes (T2D).

Materials and methods: Patients with inadequately controlled T2D were randomly assigned (1:1:1) to cofrogliptin 10 mg, cofrogliptin 25 mg or placebo, taken orally once every 2 weeks for a 24-week double-blind period. Eligible patients then received cofrogliptin 25 mg in a 28-week open-label extension. The primary endpoint was the change in glycated haemoglobin (HbA_1c) from baseline to week 24.

Results: In total, 475 patients (median age: 54.0 years) were randomized and received at least one dose of cofrogliptin 10 mg (n = 158), cofrogliptin 25 mg (n = 158) or placebo (n = 159); 401 patients entered the open-label extension. At week 24, the least-squares (LS) mean difference (95% confidence interval [CI]) in HbA_1c versus placebo was -0.63% (-0.81, -0.46) with cofrogliptin 10 mg and -0.59% (-0.77, -0.42) with cofrogliptin 25 mg (both p < 0.0001). The LS mean (standard error) change in HbA_1c from baseline was maintained at the end of the study in patients given open-label cofrogliptin 25 mg for an additional 28 weeks: cofrogliptin 10 mg: -0.86% (0.07); cofrogliptin 25 mg: -0.74% (0.07); placebo: -0.89% (0.07). Over the entire study, common adverse events were hyperuricaemia, hyperlipidaemia, hypertriglyceridaemia, increased lipase, upper respiratory tract infection and urinary tract infection. Hypoglycaemic events did not significantly differ between groups.

Conclusions: Cofrogliptin provided glycaemic control over 52 weeks and was generally well tolerated in patients with T2D.

Clinical trial registration: Registered on Clinicaltrials.gov with the registration number NCT04556851 (https://clinicaltrials.gov/study/NCT04556851).

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来源期刊

Diabetes, Obesity & Metabolism 医学-内分泌学与代谢

CiteScore

10.90

自引率

6.90%

发文量

319

审稿时长

3-8 weeks

期刊介绍： Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.