E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
diabetes mellitus type II with and without microalbuminuria, damaged glycocalyx |
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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 |
Primary Objective: Aim of the study is to investigate whether sulodexide treatment reverses damage of the systemic glycocalyx in patients with DM type II. The effect of sulodexide will be addressed in this prospective study measuring systemic and local glycocalyx volume, vascular permeability as well as vascular function in patients with DM type II who have microalbuminuria and in patients with DM type II who do not have microalbuminuria compared to healthy controls, matched for age and sex.
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E.2.2 | Secondary objectives of the trial |
Secondary Objective(s): The second objective of the present study is to measure the effect of sulodexide in patients with DM type II with and without microalbuminuria on biochemical parameters, including micro-albuminuria and HBA1c.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male - Age between 18 and 65 years
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E.4 | Principal exclusion criteria |
- immunosuppressive drugs - Serious previous illnesses - Coagulation disorders - Primary dyslipidemias - BMI > 30 kg/m2 - Hypertension (systolic >140 mm Hg or diastolic >90 mm Hg) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Main study parameter/endpoint The change from baseline to end of the study in systemic glycocalyx volume.
Secondary study parameters/endpoints (if applicable) The change from baseline to end of the study in local sublingual glycocalyx volume, vascular permeability and endothelial function in all patients. The percentage change from baseline to end of the study in microalbuminuria in patients with DM type II who have microalbuminuria.
Other study parameters (if applicable) Body weight Baseline values of glucose, HbA1c, lipid profile, albumin, creatinin, liver enzymes, CRP.
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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 | 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 | 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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |