Diabetes & Vardenafil (DiVa)
Type 2 Diabetes Mellitus (T2DM), Endothelial Dysfunction, Erectile Dysfunction
About this trial
This is an interventional supportive care trial for Type 2 Diabetes Mellitus (T2DM) focused on measuring T2DM, ED
Eligibility Criteria
Inclusion Criteria:
- Male gender
- Signed written Consent Form
- Type 2 diabetes mellitus diagnosed within 5 years before enrolment in the study
- Body Mass Index (BMI) < 35
- ED (severe, moderate or light according to the International Index of Erectile Function - erectile function domain score < 26 (Rosen et al. 1997))
- Age range: 40-65 years.
Exclusion Criteria:
- Systemic diseases except type 2 diabetes mellitus
- Absence of ED
- Psychiatric disorders
- All contraindications to treatment with PDE5 inhibitors, such as retinitis pigmentosa, non-arteritic anterior ischaemic optic neuropathy, history of coronary artery disease, recent myocardial infarction, unstable angina, systemic arterial hypotension, nitric-oxide donors therapy, severe hepatic and renal failure.
Sites / Locations
- Unit of Endocrinology Azienda USL
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Vardenafil
Control
The study protocol consists of a Screening/Enrolment Phase lasting up to 4 weeks, a Treatment Phase of 24 weeks, and Follow-up/Observation Treatment-free Phase of 24 weeks after the Treatment Phase. During treatment phase, patients enrolled in the Study Group were treated with vardenafil 10 mg twice/daily.
The study protocol consists of a Screening/Enrolment Phase lasting up to 4 weeks, a Treatment Phase of 24 weeks, and Follow-up/Observation Treatment-free Phase of 24 weeks after the Treatment Phase. During treatment phase, patients enrolled in the Control Group were treated with tablets twice/daily identical to the Study Group, but containing placebo.