E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with type 2 diabetes and coronary artery disease. |
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MedDRA Classification |
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 |
To test the hypothesis that treatment with exenatid 10 micrograms daily during three months improves microvascular function measured by iontophoresis in patients with type 2 diabetes and coronary artery disease and that this improvement is greater than the corresponding changes with conventional treatment. |
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E.2.2 | Secondary objectives of the trial |
To study the effects of exenatid on myocardial and skin microcirculation, respectively, evaluated by Coronary Flow Reserve (CFR), laser Doppler fluxmetry (LDF), Dynamic Capillaroscopy and transcutaneous oxygen tension (TcPO2). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Type 2 diabetes mellitus 2. Treatment with Metformin and/or SU at least 3 months prior to randomisation 3. Glycated haemoglobin >6.0% 4. Coronary artery disease, i.e. previous MI, stable angina, acute coronary syndrome 5. Signed written inform consent
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E.4 | Principal exclusion criteria |
1. Age >75 or <18 years 2. Glycated haemoglobin >10% 3. Childbearing potential 4. Impaired renal function with creatinine clearance <30 ml/min 5. Current or previous treatment with exenatid 6. Current insulin use 7. Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol 8. Participant in an ongoing study
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of the trial is to test the hypothesis that treatment with exenatid 10 micrograms daily during three months improves microvascular function measured by iontophoresis in patients with type 2 diabetes and coronary artery disease and that this improvement is greater than the corresponding changes with conventional treatment. |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |