Vildagliptin and Endothelium-dependent Vasodilatation

Radboud University Medical Center

Status and phase: Completed; Phase 3

Conditions: Endothelial Dysfunction; Type 2 Diabetes

Treatments: Drug: vildagliptin + acarbose; Drug: acarbose + vildagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT01000688

VILD1

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

vildagliptin treatment first, acarbose treatment second

Experimental group

Treatment:

Drug: vildagliptin + acarbose

acarbose treatment first, vildagliptin treatment second

Experimental group

Treatment:

Drug: acarbose + vildagliptin