Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

— DM-ASA 001  

Official title:

Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812032
• Other study ID #: EudraCT No: 2007-003186-40
• Status: Completed
• Phase: Phase 4
• Start date: January 2008
• Est. completion date: October 2010

Study information

• Verified date: May 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes. The aim of the investigators study is to test the laboratory response to different dosing of aspirin in type 2 Diabetes Mellitus. The investigators will compare the regular dose of 75mg once daily to 75 mg twice daily or to 320 mg once daily. The hypothesis of the study is that twice daily dosing of aspirin may improve the response to aspirin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Type 2 DM with micro- or macroangiopathy.

• HbA1c 6-9 % (Mono-S method).

• Need for, or already on-going aspirin treatment.

• Age 50-75 years

• Antecubital forearm veins allowing technically good sampling for platelet studies

Exclusion Criteria:

• Diet controlled DM.

• Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.

• Acute or chronic kidney disease (P-cystatin C within the reference interval)

• Acute or chronic liver disease (ALAT =2 times the upper reference value).

• A history of gastric or duodenal ulcer disease.

• Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.

• Thrombocytopenia (platelet count <150 x 109/L)

• Anticipated need for alteration of concomitant drug therapy during the course of the study.

• Enrollment in another clinical study.

• Contraindication(s) to aspirin treatment.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Aspirin
75 mg per day versus 75 mg twice daily and 320mg once daily
• aspirin
crossover study with three dosages: 75 mg once daily, 75 mg twice daily, 320 mg once daily.

Locations

Country	Name	City	State
Sweden	Department of Medicine, Clinical pharmacology Unit, Karolinska University Hospital, Solna.	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An exploratory study with three co-primary response variables which are directly related to platelet COX-1 inhibition: arachidonic acid-induced platelet aggregation in whole blood and PRP and in the Cone-and-Plate(let) Assay (CPA)		12 or 24 hours after last dose of Aspirin
Secondary	Indirectly COX-related platelet aggregation induced by collagen or ADP, and thromboxane metabolite excretion.		12 or 24 hours after last dose of aspirin