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

• Status: Recruiting
• Trial end date: 2022-08-08
• Target enrollment: 0
• Participant gender: All

Summary

This phase 1 study will include patients suffering from type 2 diabetes mellitus and will study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. The aims are to determine the feasibility of a phase 2 larger scale trial, and to characterize the prevalence of incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily. Platelet function will be assessed at baseline and a day 7.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montreal Heart Institute
• Collaborator: Institut de Recherches Cliniques de Montreal
• Treatments: Aspirin

Criteria

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.