30 Participants Needed

Aspirin Dosing for Type 2 Diabetes

(APPEASEDII Trial)

GM
ML
Overseen ByMarie Lordkipanidzé B. Pharm, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Montreal Heart Institute
Must be taking: Oral antihyperglycemics, Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

Aspirin, also known as acetylsalicylic acid (ASA), has been shown to affect platelet function and increase bleeding times in healthy people, especially at doses around 100 mg daily. It is generally considered safe for use in humans, but it can increase the risk of bleeding.12345

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

GM

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

I haven't taken ASA regularly in the last 3 months or at all in the last 2 weeks.
I have type 2 diabetes.
I am willing to attend all required study visits.

Exclusion Criteria

I am on regular medication for a chronic inflammatory condition.
I have had blood cancer or a condition that affects how my blood cells form.
Your blood platelet count or hemoglobin levels are not within the normal range.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Run-in

Participants receive 80 mg of enteric-coated aspirin daily for 7 days to assess initial response

1 week
2 visits (in-person)

Randomized Treatment

Participants are randomized to one of three ASA regimens for 7 days each, with washout periods in between

3 weeks (plus washout periods)
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Aspirin
Trial Overview The trial is testing how different doses and forms of aspirin affect blood platelet function in people with type 2 diabetes over a week. It compares daily enteric-coated aspirin (81 mg twice or 162 mg once) versus chewable aspirin (40 mg twice), focusing on which regimen best prevents platelets from clumping together.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: chewable ASA 40 mg twice daily for 7 daysExperimental Treatment1 Intervention
chewable ASA 40 mg twice daily for 7 days
Group II: EC ASA 81 mg twice daily for 7 daysExperimental Treatment1 Intervention
EC ASA 81 mg twice daily for 7 days
Group III: EC ASA 162 mg once daily for 7 daysExperimental Treatment1 Intervention
EC ASA 162 mg once daily for 7 days

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

🇪🇺
Approved in European Union as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
🇺🇸
Approved in United States as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
🇨🇦
Approved in Canada as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
🇨🇳
Approved in China as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montreal Heart Institute

Lead Sponsor

Trials
125
Recruited
85,400+

Heart and Stroke Foundation of Canada

Collaborator

Trials
131
Recruited
72,600+

Institut de Recherches Cliniques de Montreal

Collaborator

Trials
72
Recruited
10,300+

Findings from Research

In a study involving healthy volunteers who took varying doses of acetylsalicylic acid (ASA) for one week, all doses significantly inhibited platelet function and increased bleeding times, indicating its effectiveness in thrombosis prophylaxis.
The research found that a daily dose of around 100 mg of ASA maximized the effects on platelet function and bleeding time, suggesting that higher doses do not provide additional benefits.
The effects of different doses of some acetylsalicylic acid formulations on platelet function and bleeding times in healthy subjects.McLeod, LJ., Roberts, MS., Cossum, PA., et al.[2019]
Aspirin (ASA) significantly reduced urinary 11-dehydro-thromboxane B2 levels by about 71.5% in patients with type 2 diabetes and 75.1% in healthy controls, indicating its effectiveness in inhibiting platelet activation through COX-1 inhibition.
Despite the reduction in thromboxane levels, many patients with type 2 diabetes were identified as 'poor responders' to ASA, suggesting that oxidative stress may counteract the effects of ASA and maintain platelet function, highlighting a potential challenge in treating this population.
Aspirin insensitive thromboxane generation is associated with oxidative stress in type 2 diabetes mellitus.Ames, PR., Batuca, JR., Muncy, IJ., et al.[2013]
In a study involving 2539 patients with type 2 diabetes, low-dose aspirin did not reduce the risk of cardiovascular events over a median follow-up of 10.3 years, indicating it may not be effective for primary prevention in this population.
However, the use of low-dose aspirin was associated with an increased risk of gastrointestinal bleeding, with 2% of patients in the aspirin group experiencing this side effect compared to 0.9% in the no-aspirin group.
Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus: 10-Year Follow-Up of a Randomized Controlled Trial.Saito, Y., Okada, S., Ogawa, H., et al.[2020]

References

The effects of different doses of some acetylsalicylic acid formulations on platelet function and bleeding times in healthy subjects. [2019]
Aspirin insensitive thromboxane generation is associated with oxidative stress in type 2 diabetes mellitus. [2013]
Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus: 10-Year Follow-Up of a Randomized Controlled Trial. [2020]
Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. [2023]
Aspirin for primary prevention in patients with diabetes mellitus. [2013]
Twice daily dosing of aspirin improves platelet inhibition in whole blood in patients with type 2 diabetes mellitus and micro- or macrovascular complications. [2013]
Increased blood plasma hydrolysis of acetylsalicylic acid in type 2 diabetic patients: a role of plasma esterases. [2017]
Pharmacokinetic study of a new oral buffered acetylsalicylic acid (ASA) formulation in comparison with plain ASA in healthy volunteers. [2013]
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