E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes and Healthy volunteers |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes and Healthy volunteers |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012594 |
E.1.2 | Term | Diabetes |
E.1.2 | System Organ Class | 100000004861 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim is to investigate the effect of aspirin on platelet aggregation, endothelial-dependent vasodilation and arterial stiffness during 24 hours in patients with type 2 diabetes without known cardiovascular disease and in healthy controls. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diabetics: Age > 18 years and a diagnosis of type 2 diabetes. Controls: age > 18 years and exclusion of type 2 diabetes by oral glucose tolerance test.
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E.4 | Principal exclusion criteria |
Current treatment with antiplatelet drugs or anticoagulants including aspirin. Treatment with non-steroidal antiinflammatory drugs. Aspirin hypersensitivity. Pregnancy. Gastrointestinal bleeding within the last month. Platelet disease and/or bleeding diseases. Low platelet count (< 120 x 109/L). Active cancer diagnose, chronic or acute infection, dialysis. Known Cardiovascular disease. Inability to give informed consent.
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E.5 End points |
E.5.1 | Primary end point(s) |
24-hour antiplatelet effects of aspirin (maintenance therapy): To investigate the effect of aspirin on platelet aggregation early and late in the 24-hour dosing interval in patients with type 2 diabetes and healthy controls receiving aspirin as maintenance therapy.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
24-hour vascular effects of aspirin (maintenance therapy): To investigate the effect of aspirin on endothelial-dependent vasodilation and arterial stiffness early and late in the 24-hour dosing interval in patients with type 2 diabetes and healthy controls receiving aspirin as maintenance therapy.
Acute effects of aspirin (aspirin-naïve): To investigate the acute effect of aspirin on platelet aggregation, endothelial-dependent vasodilation and arterial stiffness in aspirin-naïve patients with type 2 diabetes and healthy controls.
24 hour platelet turnover: To investigate platelet turnover early and late in the 24-hour dosing interval of aspirin in patients with type 2 diabetes and healthy controls.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial is considered finished 2 days after the last patient’s last visit. The 2 days are to secure that the last trial subject does not experience adverse events or adverse reactions after ending of the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |