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Vildagliptin and Endothelium-dependent Vasodilatation

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01000688
First received: October 21, 2009
Last updated: November 4, 2010
Last verified: October 2009
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes
Endothelial Dysfunction
 Drug: vildagliptin + acarbose
Drug: acarbose + vildagliptin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

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

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of vildagliptin on inflammatory markers and adipokines [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Effect of vildagliptin on fat cell morphology and gene expression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000688

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

No publications provided

Responsible Party: Prof. Dr. C.J. Tack, UMC St Radboud
ClinicalTrials.gov Identifier: NCT01000688     History of Changes
Other Study ID Numbers: VILD1
Study First Received: October 21, 2009
Last Updated: November 4, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on May 21, 2013