Aspirin Dosing for Type 2 Diabetes
(APPEASEDII Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that participants do not take aspirin regularly before joining, and those on certain medications like anticoagulants, antiplatelet agents, NSAIDs, or systemic steroids cannot participate. If you're on these medications, you may need to stop them to join the trial.
Is aspirin safe for humans?
How does aspirin dosing differ for type 2 diabetes treatment?
Aspirin, when taken twice daily at a low dose, may be more effective for people with type 2 diabetes because it better inhibits platelet activity, which is important for preventing blood clots. This is different from the usual once-daily dosing and is particularly relevant for those with diabetes who have increased platelet turnover.15678
Research Team
Guillaume Marquis Gravel, MD, MSc
Principal Investigator
ICM Co. Ltd.
Eligibility Criteria
Adults with type 2 diabetes who haven't taken aspirin regularly in the past 3 months can join. They must be willing to attend all study visits and not have any planned major surgeries, bleeding disorders, severe liver issues, active cancer, chronic inflammatory diseases needing anti-inflammatory drugs, high-risk GI bleeding conditions or need for dialysis.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants receive 80 mg of enteric-coated aspirin daily for 7 days to assess initial response
Randomized Treatment
Participants are randomized to one of three ASA regimens for 7 days each, with washout periods in between
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Aspirin
Aspirin is already approved in European Union, United States, Canada, China for the following indications:
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montreal Heart Institute
Lead Sponsor
Heart and Stroke Foundation of Canada
Collaborator
Institut de Recherches Cliniques de Montreal
Collaborator