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

• Status: Not yet recruiting
• Trial end date: 2024-02-08
• Target enrollment: 0
• Participant gender: All

Summary

This phase 2 study will include patients suffering from type 2 diabetes mellitus and will first study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. Participants with an incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily will be randomized to a random order of 3 different ASA regimens: EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily. The aims are to determine the feasibility of a larger scale trial, and to determine the regimen associated with the lowest proportion of non-responders after randomization. Platelet function will be assessed at baseline and at day 7 of each arms of the study.

• Phase: 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 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;