E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Our primary objective is to elucidate whether increase in cGMP mediated by acute administration of tadalafil, a selective well tolerated PDE-5 inhibitor, may affect capillary recruitment and muscle glucose uptake in type 2 diabetes subjects following a mixed meal. Our secondary objective is to elucidate whether tadalafil may modulate arterial stiffness as indicated by changes in pulse wave velocity.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012613 |
E.1.2 | Term | Diabetes mellitus non-insulin-dependent |
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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 |
To elucidate whether increase in cGMP mediated by acute administration of tadalafil, a selective well tolerated PDE-5 inhibitor, may affect capillary recruitment and muscle glucose uptake in type 2 diabetes subjects following a mixed meal.
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E.2.2 | Secondary objectives of the trial |
To elucidate whether tadalafil may modulate arterial stiffness as indicated by changes in pulse wave velocity.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be acceptable for the study the type 2 diabetic subjects have to fulfill the following criteria: 1) Post-menopausal state, defined as natural amenorrhea for at least 12 months, age 52-67 yr or males 40-65 years; 2) Type 2 diabetes diagnosed or indicated by fasting or 2-hr OGTT plasma glucose levels (diabetes duration < 3 years).
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E.4 | Principal exclusion criteria |
1) Subjects with concurrent use of nitrates or NO donors, history of coronary heart or cerebrovascular disease, cardiac failure (stages NYHA II-IV), uncontrolled hypertension, significant diabetic complications, and inadequate glycemic control (HbA1c > 6.5%, ref values: 3.5-5.3%) will be excluded; 2) Patients on glitazones, insulin, beta-blockers, ACE-inhibitors, Angiotensin II Receptor subtype 1 Blocker or corticosteroids will be excluded.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints are PS for glucose in muscle and uptake of glucose in the brachioradialis muscle following a mixed meal as well as Area Under the Curve (AUC) for plasma glucose following the meal. If the data suggest an enhanced glucose uptake induced by tadalafil there may be a new indication for the drug. The secondary endpoint will be to estimate the effects of tadalafil on indices of arterial stiffness.
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 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) | 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 | 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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Last visit of 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 | |