Vildagliptin and Endothelium-dependent Vasodilatation

Phase 3

Completed

• Conditions: Type 2 Diabetes; Endothelial Dysfunction
• Interventions: Drug: vildagliptin + acarbose; Drug: acarbose + vildagliptin

• Registration Number: NCT01000688
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Study Start: 2010-01
• Primary Completion: 2010-08
• Study Completion: 2010-10
• Last Update Submitted: 2010-11-04
• Last Update Posted: 2010-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
vildagliptin treatment first, acarbose treatment second	vildagliptin + acarbose	-
acarbose treatment first, vildagliptin treatment second	acarbose + vildagliptin	-

Primary Outcome Measures

Name	Time	Method
Forearm vasodilator response to intra-arterial infusion of acetylcholine (endothelium-dependent) following treatment with vildagliptin and following active control with acarbose	8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands