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Pharmacokinetics and Pharmacodynamics of Prusogliptin (DBPR108), a Once-Daily Dipeptidyl Peptidase-4 Inhibitor, in Patients with Type 2 Diabetes
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Pharmacokinetics and Pharmacodynamics of Prusogliptin (DBPR108), a Once-Daily Dipeptidyl Peptidase-4 Inhibitor, in Patients with Type 2 Diabetes
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Pharmacokinetics and Pharmacodynamics of Prusogliptin (DBPR108), a Once-Daily Dipeptidyl Peptidase-4 Inhibitor, in Patients with Type 2 Diabetes
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Journal Article
Pharmacokinetics and Pharmacodynamics of Prusogliptin (DBPR108), a Once-Daily Dipeptidyl Peptidase-4 Inhibitor, in Patients with Type 2 Diabetes
2025
Overview
DBPR108 (prusogliptin) is a novel, orally bioavailable dipeptidyl peptidase-4 (DPP-4) inhibitor. This study investigated the pharmacokinetics and pharmacodynamic characteristics of DBPR108 tablets in patients with type 2 diabetes.
In this randomized, parallel-group, open-label, phase I study, Chinese adults with type 2 diabetes, glycated hemoglobin of 7.0-9.5%, and body mass index of 19-35 kg/m
were randomized 1:1:1 to once-daily DBPR108 50-, 100-, or 200-mg tablet groups. The primary endpoints included pharmacokinetic and pharmacodynamic characteristics after a single dose and multiple doses of DBPR108.
In total, 30 patients were randomized with 10 patients in each group. DBPR108 was quickly absorbed with median time to reach the maximum plasma concentration of 1.5-4 h at steady state. Exposure to DBPR108 at steady-state increased dose proportionally with mean maximum steady-state plasma DBPR108 concentration during dosage intervals of 119, 256, and 567 ng/mL in the 50-, 100-, and 200-mg groups, respectively. Accumulation ratio of DBPR108 ranged from 0.85 to 1.3, and steady state was reached after four continuous daily doses. After multiple doses of DBPR108, maximum inhibitory efficacy of DPP-4 increased with higher dose levels ranging from 62.1 to 89.4%. Active glucagon-like peptide-1 levels increased after DBPR108 administration. In addition, six patients experienced treatment-emergent adverse events without leading to treatment interruption or discontinuation.
DBPR108 was well tolerated in Chinese patients with type 2 diabetes, and both the pharmacokinetic and pharmacodynamic profiles support once-daily dosage regimens of DBPR108 in future studies.
ClinicalTrials.gov (NCT05146869); registered 23 November 2021.
Publisher
Springer Nature B.V,Springer International Publishing
Subject
/ Aged
/ Butanes
/ Diabetes
/ Diabetes Mellitus, Type 2 - blood
/ Diabetes Mellitus, Type 2 - drug therapy
/ Dipeptidyl-Peptidase IV Inhibitors - administration & dosage
/ Dipeptidyl-Peptidase IV Inhibitors - adverse effects
/ Dipeptidyl-Peptidase IV Inhibitors - pharmacokinetics
/ Dipeptidyl-Peptidase IV Inhibitors - pharmacology
/ Dose-Response Relationship, Drug
/ Female
/ Glucagon
/ Glucagon-Like Peptide 1 - blood
/ Glucose
/ Glycated Hemoglobin - analysis
/ Humans
/ Hypoglycemic Agents - administration & dosage
/ Hypoglycemic Agents - adverse effects
/ Hypoglycemic Agents - pharmacokinetics
/ Hypoglycemic Agents - pharmacology
/ Insulin
/ Male
/ Nitriles
/ Original
/ Peptides
/ Piperidines - pharmacokinetics
/ Plasma
