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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Radboud University

Additional 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
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 July 22, 2014