Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With Type 2 Diabetes

What this Trial Is About

Researchers are evaluating different dosing regimens of enteric-coated aspirin in patients with type 2 diabetes mellitus to understand their effects on platelet aggregation. The study aims to assess how well patients respond to aspirin and to find the regimen with the lowest number of non-responders. This phase 2, randomized, open-label pilot trial also seeks to determine the feasibility of conducting a larger, confirmatory trial in the future. Participants will first take 80 mg of enteric-coated aspirin once daily for seven days. Those who show incomplete platelet inhibition after this run-in phase will be randomly assigned to receive one of three aspirin regimens in a crossover design 162 mg once daily, 81 mg twice daily, or 40 mg chewable twice daily. Each treatment period lasts seven days, separated by at least seven days of washout. During the study, blood samples will be collected to assess platelet function and serum salicylate levels. Throughout the trial, participants will attend multiple visits for blood draws and platelet function testing using Light Transmission Aggregometry. Adherence will be tracked by pill counts and questioning at visits. The primary outcomes include measuring the rate of aspirin non-responders and evaluating the feasibility of a larger trial by tracking screening, enrollment, retention, and consent rates. Secondary outcomes assess adherence, time to complete study procedures, and platelet response to different aspirin doses and other platelet activators. Total participation may extend over several months due to treatment and washout periods.

Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II