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Vildagliptin and Endothelium-dependent Vasodilatation

Primary Purpose

Type 2 Diabetes, Endothelial Dysfunction

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
vildagliptin + acarbose
acarbose + vildagliptin
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud University Nijmegen Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

vildagliptin treatment first, acarbose treatment second

acarbose treatment first, vildagliptin treatment second

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of vildagliptin on inflammatory markers and adipokines
Effect of vildagliptin on fat cell morphology and gene expression
Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli

Full Information

First Posted
October 21, 2009
Last Updated
November 4, 2010
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01000688
Brief Title
Vildagliptin and Endothelium-dependent Vasodilatation
Official Title
The Effect of Vildagliptin on Endothelium-dependent Vasodilatation. A Double Blind Cross-over Study in Type 2 Diabetes Mellitus.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Endothelial Dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vildagliptin treatment first, acarbose treatment second
Arm Type
Experimental
Arm Title
acarbose treatment first, vildagliptin treatment second
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
vildagliptin + acarbose
Intervention Description
4 week treatment
Intervention Type
Drug
Intervention Name(s)
acarbose + vildagliptin
Intervention Description
4 week treatment
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Effect of vildagliptin on inflammatory markers and adipokines
Time Frame
8 weeks
Title
Effect of vildagliptin on fat cell morphology and gene expression
Time Frame
8 weeks
Title
Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C.J. Tack, MD, PhD, Prof. of Diabetology
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24485397
Citation
van Poppel PC, Gresnigt MS, Smits P, Netea MG, Tack CJ. The dipeptidyl peptidase-4 inhibitor vildagliptin does not affect ex vivo cytokine response and lymphocyte function in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2014 Mar;103(3):395-401. doi: 10.1016/j.diabres.2013.12.039. Epub 2014 Jan 3.
Results Reference
derived

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Vildagliptin and Endothelium-dependent Vasodilatation

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