Study to examine whether single (100mg) or double (200 mg) doses of aspirin can reduce blood clotting in diabetic patients without heart disease and to determine whether the double dose is more effective when given as 100mg twice a day.

Conditions: MedDRA version: 14.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Type 2 Diabetes mellitus
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-003123-35-GB

Lead Sponsor: niversity of Oxford

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients will be eligible for the study if they: • Have type 2 diabetes (defined according to the European Association for the Study of Diabetes guidelines) • Are aged =18 years and <55 years • Have not had a coronary event or other indication requiring ASA • Have been on stable doses of antihyperglycaemic medication, i.e. the type of medication or dose used has not been changed for at least 3 months. • Have HbA1c levels =8.0% • Have triglycerides =2mmol/l
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients will be ineligible for the study if they: • Have cardiovascular disease, including coronary heart disease, stroke and peripheral artery disease • Have been taking aspirin (ASA), non-steroidal anti-inflammatory drugs, any antiplatelet or antithrombotic drugs within the last 30 days • Have a history of peptic ulcer disease • Are treated with insulin • Have high blood pressure (>150 mmHg systolic or >100 mmHg diastolic) • Have a known bleeding disorder • Have a known gastro-intestinal disorder • Have evidence of severe hepatic disease or ALT >3 times of the upper limit. • Have evidence of renal dysfunction or eGFR <40ml/min/1.73m2 • Have a contraindication to ASA, such as allergy or active bleeding • Have a planned intervention or surgery in the next 3 months • Are pregnant or lactating women • Have a history of any medical condition that would place them at risk as a result of a blood donation • Are currently taking part, or have completed, an Investigational Medicinal Product (IMP) trial within the last 3 months • Are felt to be unsuitable for the trial as decided by a principal investigator