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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
APPEASEDII Trial 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.Check my eligibility
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.See study design
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.
APPEASEDII Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have type 2 diabetes.
Select...
I am 18 years old or older.
Select...
I am willing to attend all required study visits.
APPEASEDII Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreAPPEASEDII 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?
Montreal Heart InstituteLead Sponsor
121 Previous Clinical Trials
68,889 Total Patients Enrolled
Institut de Recherches Cliniques de MontrealOTHER
70 Previous Clinical Trials
10,338 Total Patients Enrolled
Guillaume Marquis Gravel, MD, MScPrincipal InvestigatorICM Co. Ltd.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on regular medication for a chronic inflammatory condition.I haven't taken ASA regularly in the last 3 months or at all in the last 2 weeks.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.I have type 2 diabetes.I require dialysis.You are allergic to aspirin.I currently have active cancer.I am 18 years old or older.I am willing to attend all required study visits.I have a high risk of bleeding in my stomach or intestines.I am on long-term medication for blood thinning, pain, inflammation, or steroids.I have a condition that requires me to take aspirin due to heart or artery disease.I am planning to have a major surgery or dental procedure during the study.I have a bleeding disorder.My liver is not working well or my ALT levels are three times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: EC ASA 81 mg twice daily for 7 days
- Group 2: EC ASA 162 mg once daily for 7 days
- Group 3: chewable ASA 40 mg twice daily for 7 days
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any potential risks associated with taking EC ASA 162 mg daily for a week?
"Our team at Power assigned EC ASA 162 mg once daily for 7 days a score of 1 due to its limited supporting data from Phase 1 trials."
Answered by AI
Is there still availability for patients to participate in this research?
"Clinicaltrials.gov affirms that this medical trial is not actively in search of participants at the moment, despite its initial posting date on February 1st 2023 and latest update taking place on January 25th 2023. Although no longer open to enrolment, 1426 other clinical trials are still recruiting patients currently."
Answered by AI
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