Pharmacokinetics and Safety of Chiglitazar, a Peroxisome Proliferator-Activated Receptor Pan-Agonist, in Patients < 65 and ≥ 65 Years With Type 2 Diabetes

The effect of age on the pharmacokinetics and safety of chiglitazar was evaluated in patients < 65 and >= 65 years with type 2 diabetes mellitus (T2DM). A total of 20 T2DM patients (<65 vs >= 65 years 1:1) completed the study. Patients received multiple doses of 48 mg chiglitazar once daily for 7 days consecutively. After the first dosing, chiglitazar maximum plasma concentration (C-max) and area under the plasma concentration-time curve (AUC) in patients >= 65 years were similar to those observed in patients < 65 years, with the geometric mean ratio (GMR) for C-max and AUC being 97.22% and 96.83%, respectively. No significant difference was observed in C-max (GMR, 97.23%) in the steady state. Compared with the patients < 65 years, a slight increase (8%-13%) of AUC was observed in the patients >= 65 years after multiple doses. Chiglitazar was generally well tolerated following multiple doses in both age groups. In conclusion, there were no significant clinical influences on the pharmacokinetic properties and safety profiles of chiglitazar between patients with T2DM < 65 and >= 65 years, indicating that in the future it is not required to adjust the dosing regimen by age for T2DM patients >= 65 years.

Automated summary

This study found no significant clinical influences on the pharmacokinetic properties and safety profiles of chiglitazar between patients with type 2 diabetes mellitus under 65 and over 65 years old, indicating that adjusting the dosing regimen by age for older patients with T2DM is not necessary in the future.