The effect of vildagliptin on endothelial dysfunction in type 2 diabetes, assessed by measuring endothelium-dependent vasodilatation MedDRA version: 12.0 Level: LLT Classification code 10048554 Term: Endothelial dysfunction
Conditions
Interventions
Trade Name: Galvus
Product Name: Vildagliptin
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Glucobay
Product Name
Sponsors
UMC St Radboud
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 •To determine the effect of vildagliptin on fat cell morphology and gene expression following a four week treatment with either vildagliptin or acarbose • 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 ;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 | — |
Countries
Netherlands
Outcome results
None listed