The Effect of Vildagliptin on Endothelium-dependent Vasodilatation. A Double Blind Cross-over Study in Type 2 Diabetes Mellitus.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Forearm vasodilator response to intra-arterial infusion of acetylcholine (endothelium-dependent) following treatment with vildagliptin and following active control with acarbose
Study Overview
Brief Summary
Rationale: Cardiovascular complications in type 2 diabetes are the leading cause of morbidity and mortality associated with the disease. Endothelial dysfunction is regarded as an important factor in these vascular complications.
The introduction of glucagon-like peptide-1 (GLP-1) analogues and dipeptidyl peptidase IV (DPP-IV) inhibitors for the treatment of type 2 diabetes is of special interest because of possible influences on endothelial function. Numerous reports have shown that GLP-1 improves endothelial function.
Objective: To determine whether a four week treatment with vildagliptin compared to acarbose improves endothelial dysfunction in patients with type 2 diabetes mellitus.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes
- •Age 35-75 years
- •Treatment with metformin monotherapy or metformin combination therapy
- •HbA1c <8.0%
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
Arms & Interventions
vildagliptin treatment first, acarbose treatment second
Intervention: vildagliptin + acarbose (Drug)
acarbose treatment first, vildagliptin treatment second
Intervention: acarbose + vildagliptin (Drug)
Outcomes
Primary Outcomes
Forearm vasodilator response to intra-arterial infusion of acetylcholine (endothelium-dependent) following treatment with vildagliptin and following active control with acarbose
Time Frame: 8 weeks
Secondary Outcomes
- Effect of vildagliptin on inflammatory markers and adipokines(8 weeks)
- Effect of vildagliptin on fat cell morphology and gene expression(8 weeks)
- Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli(8 weeks)