Impact of single versus double dose acetylsalicylic acid on platelet function in patients with type 2 diabetes

Phase 4

Completed

• Conditions: Diabetes (type 2); Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN34087526
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-31
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Inclusion criteria as of 08/02/2016:
1. Have type 2 diabetes (defined according to the European Association for the Study of Diabetes (EASD) guidelines)
2. Are aged between 18 years and 75 years
3. Have not had a coronary event or other indication requiring ASA
4. Are on diet alone or stable doses of antihyperglycaemic medication, i.e. the type of medication or dose used has not been changed for at least 3 months
5. Have HbA1c levels = 10.0%
6. Have triglycerides = 2mmol/l

Original inclusion criteria:
1. Have type 2 diabetes (defined according to the European Association for the Study of Diabetes (EASD) guidelines)
2. Are aged between 18 years and 55 years
3. Have not had a coronary event or other indication requiring ASA
4. Are on diet alone or stable doses of antihyperglycaemic medication, i.e. the type of medication or dose used has not been changed for at least 3 months
5. Have HbA1c levels = 8.0%
6. Have triglycerides = 2mmol/l

Exclusion Criteria

1. Have cardiovascular disease, including coronary heart disease, stroke and peripheral artery disease
2. Have been taking any dose of ASA, non-steroidal anti-inflammatory drugs, any antiplatelet or antithrombotic drugs within the last 30 days
3. Have a history of peptic ulcer disease
4. Are treated with insulin
5. Have high blood pressure (>150 mmHg systolic or >100 mmHg diastolic
6. Have a known bleeding disorder
7. Have a known gastrointestinal disorder
8. Have evidence of severe hepatic disease or ALT >3 times the upper limit of normal at screening
9. Have evidence of severe renal dysfunction or estimated glomerular filtration rate (eGFR) <40ml/min/1.73m2 at screening
10. Have a contraindication to ASA, such as allergy or active bleeding
11. Have a planned intervention or surgery in the next 3 months
12. Are pregnant or lactating women
13. Are currently taking part, or have completed, an Investigational Medicinal Product (IMP) trial within the last 3 months
14. Are unsuitable for the trial as decided by a clinician

Study & Design

• Study Type: Interventional
• Study Design: Not specified