The effect of vildagliptin on endothelium-dependent vasodilatation. A double blind, cross-over study in type 2 diabetes. - Vildagliptin and vasodilatatio

Phase 1

• Conditions: The effect of vildagliptin on endothelial dysfunction in type 2 diabetes, assessed by measuring endothelium-dependent vasodilatation; MedDRA version: 12.0Level: LLTClassification code 10048554Term: Endothelial dysfunction

• Registration Number: EUCTR2009-016053-18-NL
• Lead Sponsor: MC St Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-15
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

The research population will consist of patients with type 2 diabetes of all ethnic backgrounds, both sexes and age 35-75 years.
Inclusion criteria
•Type 2 diabetes
•Age 35-75 years
•Treatment with metformin monotherapy or metformin combination therapy
•HbA1c <8.0 %

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Renal disease defined as creatinine level > 130 umol/l
• Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
• Current use of acetylsalicylic acid or vitamine K antagonists
• History of smoking within the past year
• History of or current abuse of drugs or alcohol
• History of heartfailure (NYHA class III or IV)
• Abnormalities on ECG that might interfere with current study protocol
• Pregnancy or breastfeeding
• Inability to understand the nature and extent of the trial and procedures required
• Presence of any medical condition that might interfere with the current study protocol
• Participation in a drug trial within 60 days prior to the first dose

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether a four week treatment with vildagliptin compared to acarbose improves endothelial dysfunction in patients with type 2 diabetes mellitus.;Secondary Objective: •To determine the effect of vildagliptin on plasma levels of inflammatory markers and adipokines following a four week treatment with either vildagliptin or acarbose<br>•To determine the effect of vildagliptin on fat cell morphology and gene expression following a four week treatment with either vildagliptin or acarbose<br>• To determine the effect of vildagliptin on peripheral blood mononuclear cell responses to various stimuli following a four week treatment with vildagliptin compared to acarbose<br><br>;Primary end point(s): Forearm vasodilatory response to increasing doses of intra-arterially administered acetylcholine (endothelium-dependent) and sodium nitroprusside (endothelium-independent) following 4 week treatment with vildagliptin and acarbose