Article(id=1292130396158841576, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.06.011, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1769616000000, receivedDateStr=2026-01-29, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997493065, onlineDateStr=2026-08-06, pubDate=1774627200000, pubDateStr=2026-03-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997493065, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997493065, creator=13701087609, updateTime=1785997493065, updator=13701087609, issue=Issue{id=1292130360968630762, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='6', pageStart='751', pageEnd='900', issueExtLink='null', onlineDate='null', pubDate='1774627200000', pubDateStr='2026-03-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997484675, creator='13701087609', updateTime=1786014452071, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201527440068743, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201527440068744, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=820, endPage=827, ext={EN=ArticleExt(id=1292130396515357417, articleId=1292130396158841576, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Population pharmacokinetics and pharmacodynamics of a novel GLP-1 analogue in type 2 diabetes patient, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective To establish a population pharmacokinetic-pharmacodynamic (PK-PD) model of a novel glucagon-like peptide-1 (GLP-1) analogue in patients with type 2 diabetes mellitus (T2DM), using HbA1c levels after 52 weeks of treatment as the efficacy endpoint and based on a nonlinear mixed-effects model (NLME).
Methods A population PK-PD linkage model was developed via the NLME approach, utilizing 1 967 plasma concentration data points and 1 813 observed HbA1c data points from 409 T2DM subjects enrolled in a Phase Ⅲ clinical trial. Model robustness and predictive performance were comprehensively validated using diagnostic plots, visual predictive check (VPC), and the Bootstrap method.
Results The PK characteristics were best described by a one-compartment model with first-order absorption and first-order elimination, while the PD model was a plasma concentration-driven indirect response model. Key parameters were estimated as follows: apparent volume of distribution (V/F)=11.28 L, apparent clearance (CL/F)=1.11 L·day-1, maximum inhibitory effect (Imax)=0.30, and half-maximal inhibitory concentration (IC50)=37.77 ng·mL-1. Covariate analysis revealed that baseline body weight was a significant factor affecting CL/F, and baseline HbA1c (group 1: HbA1c < 8.5%; group 2: HbA1c ≥ 8.5%) influenced the parameter kin.
Conclusion The nonlinear mixed-effects model effectively utilizes sparsely sampled data, and the obtained PK-PD parameter estimates are robust and reliable.
, authors=Na XIE
1, Min-guang ZHANG
2, Run NAN
2, Si-qi WANG
1, Ya-he ZHU
1, Ying WU
1, Heng-hui LIU
2, authorsList=Na XIE, Min-guang ZHANG, Run NAN, Si-qi WANG, Ya-he ZHU, Ying WU, Heng-hui LIU, authorCompany=null, correspAuthors=Ying WU, Heng-hui LIU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292130396804764395, articleId=1292130396158841576, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=新型GLP-1类似物在T2DM患者中的群体药代动力学和药效学研究, columnId=1246531407988805834, journalTitle=中国临床药理学杂志, columnName=药代动力学与生物等效性研究, runingTitle=null, highlight=null, articleAbstract=
目的 以治疗52周后的糖化血红蛋白（glycated hemoglobin，HbA1c）值为效应终点，基于非线性混合效应模型构建新型胰高血糖素样肽1（GLP-1）类似物在2型糖尿患者中的群体药代动力学-药效学（pharmacokinetics-pharmacodynamics，PK-PD）模型。
方法 基于一项Ⅲ期临床试验中409例2型糖尿病受试者的1 967条血药浓度数据和1 813条HbA1c的观测数据，采用非线性混合效应模型法构建群体PK-PD链接模型。结合诊断图、可视化预测检验（visual predictive check，VPC）及Bootstrap法对模型的稳健性与预测效能进行全面验证。
结果 PK特征符合一级吸收和一级消除的一房室模型，PD模型为以血药浓度驱动的间接效应模型。表观分布容积（V/F）：11.8/L，表观清除率（CL/F）：1.11 L·d-1，最大抑制效应（Imax）：0.30，半抑制浓度（IC50）：37.77 ng·mL-1。协变量分析显示，基线体重是CL/F的显著影响因素；基线HbA1c（HbA1c<8.5%，group=1;HbA1c≥8.5%，group=2）是kin的影响因素。
结论 基于非线性混合效应模型能有效利用稀疏采样数据，所获PK-PD参数估计值稳健可靠。
, authors=谢娜
1, 张敏广
2, 南润
2, 王思琪
1, 朱亚河
1, 武英
1, 刘亨辉
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谢娜（2000-），女，硕士研究生，主要从事群体药代动力学和药效动力学建模方面的研究
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