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Vildagliptin and Endothelium-dependent Vasodilatation

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ClinicalTrials.gov Identifier: NCT01000688
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : November 5, 2010
Information provided by:
Radboud University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Endothelial Dysfunction Drug: vildagliptin + acarbose Drug: acarbose + vildagliptin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Vildagliptin on Endothelium-dependent Vasodilatation. A Double Blind Cross-over Study in Type 2 Diabetes Mellitus.
Study Start Date : January 2010
Primary Completion Date : August 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Effect of vildagliptin on inflammatory markers and adipokines [ Time Frame: 8 weeks ]
  2. Effect of vildagliptin on fat cell morphology and gene expression [ Time Frame: 8 weeks ]
  3. Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000688

Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Principal Investigator: C.J. Tack, MD, PhD, Prof. of Diabetology Radboud University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. C.J. Tack, UMC St Radboud
ClinicalTrials.gov Identifier: NCT01000688     History of Changes
Other Study ID Numbers: VILD1
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: November 5, 2010
Last Verified: October 2009

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors