Evidence mapPaperPMID 39367290Full record

ArticleClinical pharmacokinetics2024

Use of a PK/PD Model to Select Cetagliptin Dosages for Patients with Type 2 Diabetes in Phase 3 Trials.

Jinmiao Lu, Jiahong Zhao, Daosheng Xie, Juping Ding, Qiang Yu, Tong Wang

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Article in Clinical pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

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0 citing papers in PubMed.

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4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Jinmiao LuCGeneTech (Suzhou, China) Co., Ltd., 218 Xinghu Street, Suzhou, 215123, China. lujm@cgenetech.com.cn.ORCID 0000-0002-3782-6645
Jiahong ZhaoCGeneTech (Suzhou, China) Co., Ltd., 218 Xinghu Street, Suzhou, 215123, China.
Daosheng XieBeijing Noahpharm Medical Technology Co., Ltd., Beijing, China.
Juping DingCGeneTech (Suzhou, China) Co., Ltd., 218 Xinghu Street, Suzhou, 215123, China.
Qiang YuCGeneTech (Suzhou, China) Co., Ltd., 218 Xinghu Street, Suzhou, 215123, China.
Tong WangCGeneTech (Suzhou, China) Co., Ltd., 218 Xinghu Street, Suzhou, 215123, China. wangt@cgenetech.com.cn.

Funding

2018ZX09301007-001 2018ZX09301007-001
6 · The paper itself

Abstract

backgroundCetagliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor developed for the treatment of patients with type 2 diabetes (T2D). Several phase 1 studies have been conducted in China. Modelling and simulation were used to obtain cetagliptin dose for phase 3 trials in T2D patients.

methodsA pharmacokinetic (PK)/pharmacodynamic (PD) model and model-based analysis of the relationship between hemoglobin A1c (HbA1c) and dosage was explored to guide dose selection of cetagliptin for phase 3 trials. The PK/PD data were derived from four phase 1 clinical studies, and sitagliptin 100 mg was employed as a positive control in studies 1, 3, and 4.

resultsThe PK profiles of cetagliptin were well described by a two-compartment model with first-order absorption, saturated efflux, and first-order elimination. The final PD model was a sigmoid maximum inhibitory efficacy (E

conclusionsThe PK/PD model supports dose selection of cetagliptin for phase 3 trials. A model‑informed approach can be used to replace a dose-finding trial and accelerate cetagliptin's development.

Indexed as

Diabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsModels, BiologicalSitagliptin PhosphateAdultAgedClinical Trials, Phase III as TopicDose-Response Relationship, DrugFemaleGlycated HemoglobinHumansHypoglycemic AgentsMaleMiddle AgedDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsSitagliptin Phosphate

Identifiers

PMID39367290

What Socratic holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.