Aspirin sensitivity in diabetes mellitus; the role of glycaemic control and dosing - ASSIG

Conditions: Type 2 diabetes
MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

Registration Number: EUCTR2008-001308-22-NL

Lead Sponsor: Academic Medical Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age > 18 years
Diagnosis of type 2 diabetes according to ADA criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Current acetylsalicylic acid therapy
Use of any medication interfering with platelet function, e.g. diclofenac, naproxen or clopidogrel in the two weeks prior to the study.
Abnormal platelet count
Allergy or hypersensitivity to prostaglandinsynthetase inhibitors
Hemorrhagic stroke in medical history
Gastric complaints or gastritis/ulcus pepticum, history of gastric bleeding
Severe liver or kidneyfailure

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether laboratory acetylsalicylic acid resistance is more prevalent in type 2 diabetic patients with poor glycaemic control as compared to type 2 diabetic patients with adequate or intermediate glycaemic control and healthy subjects.;Secondary Objective: To determine whether higher doses of acetylsalicylic acid can overcome laboratory acetylsalicylic acid resistance in type 2 diabetic patients.;Primary end point(s): Prevalence of laboratory acetylsalicylic acid resistance in type 2 diabetic patients stratified by level of glycaemic control.

Secondary Outcome Measures