Vildagliptin and Endothelium-dependent Vasodilatation

Type 2 Diabetes Clinical Trial

Official title:

The Effect of Vildagliptin on Endothelium-dependent Vasodilatation. A Double Blind Cross-over Study in Type 2 Diabetes Mellitus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000688
• Other study ID #: VILD1
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2009
• Last updated: November 4, 2010
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2009
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Endothelial Dysfunction
• Type 2 Diabetes

Intervention

Drug:
• vildagliptin + acarbose
4 week treatment
• acarbose + vildagliptin
4 week treatment

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm vasodilator response to intra-arterial infusion of acetylcholine (endothelium-dependent) following treatment with vildagliptin and following active control with acarbose		8 weeks	No
Secondary	Effect of vildagliptin on inflammatory markers and adipokines		8 weeks	No
Secondary	Effect of vildagliptin on fat cell morphology and gene expression		8 weeks	No
Secondary	Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli		8 weeks	No