Evaluation of Antiplatelet Effects of Different Dosages of Aspirin in Type 2 Diabetic Patients (DM-ASA 001)

Karolinska Institute

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Aspirin

Drug: aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT00812032

EudraCT No: 2007-003186-40

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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.