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

Prior treatment

• Definitive indication for aspirin, including any evidence of atherosclerotic disease, previous or current;
• Planned major surgical procedure within 30 days of enrolment;
• Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids;

Other illness

• Known hypersensitivity to aspirin;
• High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract;
• Bleeding diathesis;
• History of hematological malignancy or myelodysplasia;
• Chronic inflammatory disease requiring regular anti-inflammatory treatment;
• Active cancer;

Lab values

• Platelet count or hemoglobin levels outside of the normal reference range;

Other

• Pregnant or lactating women.

• Age ≥ 18 years;
• Participant must be naïve to aspirin, defined as absence of chronic treatment with aspirin within the previous 3 months, and of any aspirin 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/mol);
• Willing to attend all study visits.