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

Inclusion criteria

• Age ≥ 18 years;
• Participant must be naïve to ASA, defined as absence of chronic treatment with ASA within the previous 3 months, and of any ASA use within the previous 2 weeks;
• Type 2 diabetes, based on at least one of the following criteria: (5)
• Chronic treatment with oral antihyperglycemic agents or insulin therapy;
• Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) (fasting is defined as no caloric intake for at least 8h);
• 2-h Plasma Glucose (2h-PG) ≥ 200 mg/dL (11.1 mmol/L) during the oral glucose tolerance test (OGTT);
• A1C ≥ 6.5% (48 mmol/ml);
• Willing to attend all study visits of both the run-in and randomized phases of the trial.

Exclusion criteria

• Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current;
• Known hypersensitivity to ASA;
• Patient requiring dialysis;
• Severe hepatic insufficiency or ALT \> 3 x ULN;
• High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract;
• Bleeding diathesis;
• Platelet count or hemoglobin levels outside of the normal reference range;
• Planned major surgical procedure or dental procedure during the course of the study;
• Chronic inflammatory disease requiring regular anti-inflammatory treatment;
• Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids;
• Active cancer;
• History of hematological malignancy or myelodysplasia;
• Pregnant or lactating women;