Diabetes & Vardenafil

NCT02219646 | Completed Phase 2 DMC

• 1 other identifier: EudraCT number 2009-014137-25
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Endothelial Dysfunction; Erectile Dysfunction

Keywords

T2DM; ED

Outcome Measures

Primary Outcomes (1)

• Endothelin-1

  change in serum endothelin 1 concentration

  "6 months"

Secondary Outcomes (3)

• Flow Mediated Dilation

  "baseline"

• Flow Mediated dilation (FMD)

  "6 months"

• Flow Mediated Dilation

  "One year"

Other Outcomes (3)

• carotid Intima Media Thickness

  "baseline"

• carotid Intima Media Thickness (IMT)

  "6 months"

• carotid Intima Media Thickness

  "One year"

Study Arms (2)

Vardenafil

EXPERIMENTAL

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.

Drug: Vardenafil

Control

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Vardenafil DRUG

Vardenafil 10 mg twice daily for six months

Also known as: Levitra

Vardenafil

Placebo DRUG

Placebo two tablets daily for 6 months

Control

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda USL Modena: lead

Study Sites (1)

Unit of Endocrinology Azienda USL

Modena, Modena, 41126, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Erectile Dysfunction

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Manuela Simoni, MD, PhD

  Azienda USL Modena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ordinary Professor

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: August 19, 2014
• Study Start: March 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2014
• Last Updated: August 19, 2014

Record last verified: 2014-08

Locations

IT (1)