Diabetes & Vardenafil (DiVa)
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|ClinicalTrials.gov Identifier: NCT02219646|
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Given the protective effect of nitric oxide (NO) on the endothelium and the results obtained so far in short-term, continuous treatment with phosphodiesterase-5 (PDE5) inhibitors on parameters of endothelial function, we hypothesise that chronic treatment with vardenafil can prevent or delay the deterioration of systemic endothelial function in patients with type 2 diabetes mellitus. The favourable effect of PDE5 inhibitors on sexual function in these patients has been convincingly demonstrated in the past. Here we hypothesise that vardenafil treatment can have beneficial effects on the vascular physiology in other body districts, possibly preventing the development of microangiopathy and atherosclerotic cardiovascular disease in these patients.
The main goal of this study is therefore 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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus (T2DM) Endothelial Dysfunction Erectile Dysfunction||Drug: Vardenafil Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Monitoring of Endothelial Dysfunction During Chronic Administration of Vardenafil in Patients With Type 2 Diabetes Mellitus: A Longitudinal, Randomised, Placebo-controlled, Double Blind, Phase II b, Clinical Trial|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2014|
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.
Vardenafil 10 mg twice daily for six months
Other Name: Levitra
Placebo Comparator: 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 Control Group were treated with tablets twice/daily identical to the Study Group, but containing placebo.
Placebo two tablets daily for 6 months
- Endothelin-1 [ Time Frame: "6 months" ]change in serum endothelin 1 concentration
- Flow Mediated Dilation [ Time Frame: "baseline" ]Change of flow mediated dilation evaluated by ultrasonography at brachial artery
- Flow Mediated dilation (FMD) [ Time Frame: "6 months" ]Change of FMD levels
- Flow Mediated Dilation [ Time Frame: "One year" ]Change of FMD levels
- carotid Intima Media Thickness [ Time Frame: "baseline" ]Change of ultrasonographic evaluation of intima-media thickness at both right and left carotid arteries
- carotid Intima Media Thickness (IMT) [ Time Frame: "6 months" ]Change in IMT levels
- carotid Intima Media Thickness [ Time Frame: "One year" ]change in IMT levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219646
|Unit of Endocrinology Azienda USL|
|Modena, Italy, 41126|
|Principal Investigator:||Manuela Simoni, MD, PhD||Azienda USL Modena|