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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 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.
+2 more
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.
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Heart and Stroke Foundation of CanadaOTHER
130 Previous Clinical Trials
72,761 Total Patients Enrolled
1 Trials studying Diabetes
177 Patients Enrolled for Diabetes
Montreal Heart InstituteLead Sponsor
123 Previous Clinical Trials
85,336 Total Patients Enrolled
Institut de Recherches Cliniques de MontrealOTHER
71 Previous Clinical Trials
10,370 Total Patients Enrolled
Guillaume Marquis Gravel, MD, MScPrincipal InvestigatorICM Co. Ltd.

Media Library

Aspirin (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05702463 — Phase 1
Diabetes Research Study Groups: EC ASA 81 mg twice daily for 7 days, EC ASA 162 mg once daily for 7 days, chewable ASA 40 mg twice daily for 7 days
Diabetes Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT05702463 — Phase 1
Aspirin (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05702463 — Phase 1
~19 spots leftby Jun 2027