E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
1. To study the effect of Acarbose treatment on endothelial function as a potential mechanism for the beneficial effects of better postprandial glycemic control in patients with impaired glucose tolerance or newly diagnosed diabetes mellitus
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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 |
1. To study the effect of Acarbose treatment on endothelial function as a potential mechanism for the beneficial effects of better postprandial glycemic control.
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E.2.2 | Secondary objectives of the trial |
2. To study the effect of Acarbose treatment on marker of the coagulation, fibrinolytic, and platelet function (vWF, pSelectin, FVII, fibrinogen, PAI-1; 8-Iso PGF2alpha).
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male and female subjects aged between 40 and 75 years with IGT/new diagnosed diabetes, with body mass index between 25 and 40 kg/m2 2. Patients with stable angina pectoris (<=CCS II) and angiographically documented coronary artery disease not requiring immediate revascularization 3. Informed consent
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E.4 | Principal exclusion criteria |
- Current smokers - Participation in an other clinical study during the previous 1,5 months - Evidence of significant hepatic, renal, cardiac or pulmonary insufficiency - History of malignant neoplasms (treated within the last 1 year) other than basal cell carcinoma of the skin. - Other serious diseases, which might influence the clinical course - Recent major surgery or childbirth - Pregnancy or lactation - History of malabsorption - regular intake of narcotics - regular intake of more than 30 g alcohol for female or 40 g alcohol for male - a clear deviation from the norm at the clinical findings, which, in the opinion of the Investigator, would preclude unequivocal interpretation of the findings. - Contraindication to Acarbose or previous interrupted Acarbose treatment due to serious side effects. - Type I diabetes -Pre-treatment with alpha-glucosidase inhibitors, metformin or other drugs, influencing insulin resistance. - Pre-treatment of ACE-inhibitors and statins because of their influence on endothelial function. - poor metabolic control (HBA1c>8), plasma glucose level up to 300 mg/dL postprandial
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement in endothelial-dependen Vasodliation under Acarbose treatment > 50% compared to Placebo
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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 | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |