ClinicalTrials.gg
CompletedNCT01000688Updated Nov 5, 2010

Vildagliptin and Endothelium-dependent Vasodilatation

A Phase 3 interventional study of vildagliptin + acarbose and acarbose + vildagliptin in Type 2 Diabetes and Endothelial Dysfunction, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-11-05.

Sponsored by Radboud University Medical Center · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes
  • Endothelial Dysfunction
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's planned enrollment of 16 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 984 studies on the registry; 135 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type 2 diabetes
  • Age 35-75 years
  • Treatment with metformin monotherapy or metformin combination therapy
  • HbA1c \<8.0%

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    vildagliptin treatment first, acarbose treatment second

    Drug: vildagliptin + acarbose

  • Experimental
    acarbose treatment first, vildagliptin treatment second

    Drug: acarbose + vildagliptin

Interventions

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Radboud University Nijmegen Medical Centre
    Nijmegen, 6500 HB, Netherlands
08

References and documents

Publications

  • 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. PubMed 24485397 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01000688
First posted
Oct 23, 2009
Start date
Jan 2010
Primary completion
Aug 2010
Completion
Oct 2010
Last update
Nov 5, 2010

Study contacts

C.J. Tack, MD, PhD, Prof. of Diabetology
principal investigator · Radboud University Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Vildagliptin · Acarbose

Start the discussion