Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes

NCT05105919 | Active Not Recruiting Early Phase 1

• 1 other identifier: ICM 2021-2919
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1 study will include patients suffering from type 2 diabetes mellitus and will study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. The aims are to determine the feasibility of a phase 2 larger scale trial, and to characterize the prevalence of incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily. Platelet function will be assessed at baseline and a day 7.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Aspirin; Acetylsalicylic acid; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Incomplete platelet aggregation inhibition by aspirin at 7 days.

  Incomplete platelet aggregation inhibition will be defined as ≥ 20% of residual platelet aggregation in response to arachidonic acid at a concentration of 1mM, measured by LTA (Light Transmission Aggregometry).

  7 days.

Secondary Outcomes (2)

• Serum levels of thromboxane B2

  7 days.

• Platelet aggregation response to various agonists

  7 days.

Study Arms (1)

Aspirin therapy

EXPERIMENTAL

All participants will be assigned to aspirin therapy. Participants will receive 80 mg of enteric coated aspirin per day for a 7 day period.

Drug: Aspirin 80 mg EC Tab

Interventions

Aspirin 80 mg EC Tab DRUG

Participants will receive a 7 day supply of Aspirin 80 mg EC Tab and will be instructed to take the drug at the same time every day for 7 days.

Aspirin therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Participant must be naïve to aspirin, defined as absence of chronic treatment with aspirin within the previous 3 months, and of any aspirin use within the previous 2 weeks;
• Type 2 diabetes, based on at least one of the following criteria: (5)
• Chronic treatment with oral antihyperglycemic agents or insulin therapy;
• Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) (fasting is defined as no caloric intake for at least 8h);
• h Plasma Glucose (2h-PG) ≥200 mg/dL (11.1 mmol/L) during the oral glucose tolerance test (OGTT);
• A1C ≥ 6.5% (48 mmol/mol);
• Willing to attend all study visits.

You may not qualify if:

• Definitive indication for aspirin, including any evidence of atherosclerotic disease, previous or current;
• Known hypersensitivity to aspirin;
• High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract;
• Bleeding diathesis;
• History of hematological malignancy or myelodysplasia;
• Platelet count or hemoglobin levels outside of the normal reference range;
• Planned major surgical procedure within 30 days of enrolment;
• Chronic inflammatory disease requiring regular anti-inflammatory treatment;
• Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids;
• Active cancer;
• Pregnant or lactating women.

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Institut de Recherches Cliniques de Montreal: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (4)

• Marquis-Gravel G, Roe MT, Harrington RA, Munoz D, Hernandez AF, Jones WS. Revisiting the Role of Aspirin for the Primary Prevention of Cardiovascular Disease. Circulation. 2019 Sep 24;140(13):1115-1124. doi: 10.1161/CIRCULATIONAHA.119.040205. Epub 2019 Sep 23.

  PMID: 31545683 RESULT

• ASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, Stevens W, Buck G, Barton J, Murphy K, Aung T, Haynes R, Cox J, Murawska A, Young A, Lay M, Chen F, Sammons E, Waters E, Adler A, Bodansky J, Farmer A, McPherson R, Neil A, Simpson D, Peto R, Baigent C, Collins R, Parish S, Armitage J. Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus. N Engl J Med. 2018 Oct 18;379(16):1529-1539. doi: 10.1056/NEJMoa1804988. Epub 2018 Aug 26.

  PMID: 30146931 RESULT

• Lordkipanidze M, Pharand C, Schampaert E, Palisaitis DA, Diodati JG. Heterogeneity in platelet cyclooxygenase inhibition by aspirin in coronary artery disease. Int J Cardiol. 2011 Jul 1;150(1):39-44. doi: 10.1016/j.ijcard.2010.02.025. Epub 2010 Mar 7.

  PMID: 20207433 RESULT

• Bhatt DL, Grosser T, Dong JF, Logan D, Jeske W, Angiolillo DJ, Frelinger AL 3rd, Lei L, Liang J, Moore JE, Cryer B, Marathi U. Enteric Coating and Aspirin Nonresponsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2017 Feb 14;69(6):603-612. doi: 10.1016/j.jacc.2016.11.050. Epub 2017 Jan 11.

  PMID: 28089180 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Guillaume Marquis-Gravel, MD, MSc

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: All enrolled participants will receive the same treatment.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist, Associate Professor of Medicine

Model Details: This is a single arm open-label feasibility phase 1 trial. The aim of the study if to determine the number of potentially eligible participants and the monthly recruitment rate at the MHI (Montreal Heart Institute), the Centre Épic and the IRCM (Institut de recherche clinique de Montréal) as well as participants adherence to study protocol to determine feasibility of a phase 2 trial within these centers.

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 3, 2021
• Study Start: August 26, 2021
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)