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

ICM 2023-3231

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.

2023-06-13

2024-06-01

2024-06-08

Recruiting

Early phase I

30

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;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'triple crossover', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'laboratory personnel doing the platelet function assay will be blinded to minimize potential assessment bias.'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-10-19