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

This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Aspirin, Acetylsalicylic acid, Pharmacodynamics Read More

Inclusion Criteria:

1. Age ≥ 18 years;
2. 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;

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/mol);
4. Willing to attend all study visits.

Exclusion Criteria:

1. Definitive indication for aspirin, including any evidence of atherosclerotic disease, previous or current;
2. Known hypersensitivity to aspirin;
3. High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract;
4. Bleeding diathesis;
5. History of hematological malignancy or myelodysplasia;
6. Platelet count or hemoglobin levels outside of the normal reference range;
7. Planned major surgical procedure within 30 days of enrolment;
8. Chronic inflammatory disease requiring regular anti-inflammatory treatment;
9. Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids;
10. Active cancer;
11. Pregnant or lactating women.