Vildagliptin and Endothelium-dependent Vasodilatation

November 4, 2010 updated by: Radboud University Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: vildagliptin treatment first, acarbose treatment second
Drug: vildagliptin + acarbose
4 week treatment
EXPERIMENTAL: acarbose treatment first, vildagliptin treatment second
Drug: acarbose + vildagliptin
4 week treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of vildagliptin on inflammatory markers and adipokines
Time Frame: 8 weeks
8 weeks
Effect of vildagliptin on fat cell morphology and gene expression
Time Frame: 8 weeks
8 weeks
Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: C.J. Tack, MD, PhD, Prof. of Diabetology, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (ESTIMATE)

October 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 5, 2010

Last Update Submitted That Met QC Criteria

November 4, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VILD1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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