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Clinical Trials in Canada / NCT05105919
Active, not recruiting Phase EARLY_PHASE1

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

NCT05105919 · tracked via the Priya Life Science Canada tracker
Phase
Phase EARLY_PHASE1
Started
2021-08-26
Last updated
2025-12-08

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

Aspirin 80 mg EC Tab

Aspirin 80 mg EC Tab: Participants will receive a 7 day supply of Aspirin 80 mg EC Tab and will be instructed to take the drug at the same time every day for 7 days.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Montreal Heart Institute Montreal Quebec

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05105919 on ClinicalTrials.gov ↗ ← All trials in Canada