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Nonsteroidal Anti-inflammatory Drug

Aspirin Dosing for Type 2 Diabetes (APPEASEDII Trial)

Phase 1

Recruiting

Led By Guillaume Marquis Gravel, MD, MSc

Research Sponsored by Montreal Heart Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 2 diabetes, based on at least one of the following criteria: (1) Chronic treatment with oral antihyperglycemic agents or insulin therapy, (2) Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) (fasting is defined as no caloric intake for at least 8h), (3) 2-h Plasma Glucose (2h-PG) ≥ 200 mg/dL (11.1 mmol/L) during the oral glucose tolerance test (OGTT), (4) A1C ≥ 6.5% (48 mmol/ml)

Age ≥ 18 years

Must not have

Chronic inflammatory disease requiring regular anti-inflammatory treatment

History of hematological malignancy or myelodysplasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if different doses of aspirin help type 2 diabetes patients. It'll compare response to one dose of 80mg, two doses of 80mg, one dose of 162mg and two doses of 40mg. Results will help decide best dose for larger future trials.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include gastrointestinal issues like stomach pain or ulcers, increased risk of bleeding especially if there's a history of GI tract problems, allergic reactions for those sensitive to aspirin, and potential liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have type 2 diabetes.

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I am 18 years old or older.

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I am willing to attend all required study visits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on regular medication for a chronic inflammatory condition.

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I have had blood cancer or a condition that affects how my blood cells form.

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I require dialysis.

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I currently have active cancer.

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I have a high risk of bleeding in my stomach or intestines.

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I am on long-term medication for blood thinning, pain, inflammation, or steroids.

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I have a condition that requires me to take aspirin due to heart or artery disease.

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I am planning to have a major surgery or dental procedure during the study.

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I have a bleeding disorder.

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My liver is not working well or my ALT levels are three times the normal limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Among initial ASA non-responder participants, define the proportion of participants that remain ASA non-responders with different formulations and dosing regimens of ASA.

Describe the enrollment rate by the proportion of eligible participants who consent to evaluate the feasibility of a larger scale randomized controlled trial.

Describe the enrollment rate by the proportion of referred participants who are eligible to evaluate the feasibility of a larger scale randomized controlled trial.

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Secondary study objectives

Adherence rate to study protocol

Average time per participant required to complete study enrolment and all data collection.

For the run-in phase, characterize the prevalence of ASA non-responders at steady state following a 7-day treatment with ASA EC 81 mg once daily in participants with type 2 diabetes.

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