Type 2 Diabetes mellitus MedDRA version: 14.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Bayer Aspirin protect 100 mg
Product Name: N/A
Product Code: N/A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Acetylsalicylic acid
CAS Number: 50-78-2
Other descriptive nam
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to compare the effects of single dose, double dose and split double dose aspirin (ASA) on platelet function in ASA-naïve patients with Type 2 diabetes but with no cardiovascular disease. Our hypothesis is that the high residual platelet reactivity commonly seen in ASA-treated diabetes patients might be overcome by giving higher or more frequent ASA doses. The change in platelet reactivity between baseline and the post single dose, split dose or double dose treatment period will be measured by the 'VerifyNowTM' ASA Point-of-Care test.;Secondary Objective: To determine whether the mechanism(s) for aspirin (ASA) “treatment failure” or “high platelet reactivity” in type 2 diabetics is/are COX-1 dependent or independent. (COX-1 is an important enzyme in the platelet that is affected by aspirin).;Primary end point(s): The primary endpoint is the change in platelet reactivity between baseline and post the single dose, split double dose, and double dose treatment periods, as measured by the 'VerifyNowTM' ASA Point-of-Care test after two weeks treatment on each of the three dose regimens.;Timepoint(s) of evaluation of this end point: Baseline results taken at the randomisation visit will be compared to those results obtained following the three study interventions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include a variety of COX-1 dependent and independent platelet function tests, and indirect and direct measures of platelet function, after two weeks treatment on each of the three dose regimens as follows: - Change in serum TXB2 level between baseline and on ASA treatments - Change in urinary dTxB2 levels between baseline and on ASA treatments - Change in platelet function between baseline and on ASA treatments as measured by LTA - Change in platelet function between baseline and on ASA treatments as measured by PFA-100 - Change in platelet function between baseline and on ASA treatments as measured by WBA - Change in platelet function between baseline and on ASA treatments as measured by IPF;Timepoint(s) of evaluation of this end point: Baseline results taken at the randomisation visit will be compared to those results obtained following the three study interventions. | — |
Countries
United Kingdom
Outcome results
None listed