patients affected by type 2 Diabetes mellitus and affected by mild or severe ED MedDRA version: 12.0 Level: LLT Classification code 10045248 Term: Type II diabetes mellitus with other specified manifestations
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Vardenafil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of
Sponsors
Unita` Operativa di Endocrinologia e Malattie del Metabolismo
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male gender; - Signed written Consent Form - Type 2 diabetes mellitus diagnosed within 12 months before enrolment in the study; - Body Mass Index (BMI) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Systemic diseases except type 2 diabetes mellitus; - Absence of ED; - Psychiatric disorders; - All contraindications to treatment with PDE5 inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to monitor the endothelial dysfunction during continuous treatment with vardenafil for 6 months; object of the study will be endothelin 1 and other known parameters of endothelial damage in newly diagnosed patients with type 2 diabetes mellitus;Secondary Objective: nd;Primary end point(s): The primary end point is the serum endothelin 1 concentration (decreased/not increased in the verum group vs. not decrease/increased in the placebo group). | — |
Countries
Italy
Outcome results
None listed