Assessing the effects of enteric-coated aspirin in patients with type 2 diabetes

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

This study is testing different doses of enteric-coated aspirin to see which one works best for people with type 2 diabetes who don’t respond well to a standard dose.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Montreal Heart Institute (Academic / other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT05702463 on ClinicalTrials.gov

What this trial studies

This phase 2 trial investigates the pharmacokinetics and pharmacodynamics of enteric-coated aspirin in patients with type 2 diabetes mellitus. Participants will initially receive 80 mg of aspirin daily for 7 days, followed by randomization into three different dosing regimens to evaluate their platelet response. The study aims to identify the most effective aspirin regimen for patients who do not respond adequately to the initial dose. Platelet function will be measured at baseline and after the treatment period to assess the effectiveness of each regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with type 2 diabetes who have not used aspirin in the past three months.

Not a fit: Patients with a definitive indication for aspirin or those with known hypersensitivity to aspirin may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved aspirin treatment strategies for patients with type 2 diabetes, enhancing their cardiovascular health.

How similar studies have performed: Similar studies have shown promise in optimizing aspirin regimens for cardiovascular protection, making this approach both relevant and potentially impactful.

Eligibility 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;

Where this trial is running

Montreal, Quebec

• Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Guillaume Marquis Gravel, MD, MSc — ICM Co. Ltd.
• Study coordinator: Guillaume Marquis Gravel, MD, MSc

Conditions Platelet Aggregation; Type 2 Diabetes; Aspirin; Diabetes Mellitus, Type 2; Platelet Aggregation Inhibitors; diabetes; aspirin; Acetylsalicylic acid