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

Inclusion Criteria:

1. Age ≥ 18 years;
2. 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;
3. 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);

4. Willing to attend all study visits of both the run-in and randomized phases of the trial.

Exclusion Criteria:

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