NCT01000688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_3 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 5, 2010

Status Verified

October 1, 2009

Enrollment Period

7 months

First QC Date

October 21, 2009

Last Update Submit

November 4, 2010

Conditions

Type 2 DiabetesEndothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (3)

  • Effect of vildagliptin on inflammatory markers and adipokines

    8 weeks

  • Effect of vildagliptin on fat cell morphology and gene expression

    8 weeks

  • Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli

    8 weeks

Study Arms (2)

vildagliptin treatment first, acarbose treatment second

EXPERIMENTAL
Drug: vildagliptin + acarbose

acarbose treatment first, vildagliptin treatment second

EXPERIMENTAL
Drug: acarbose + vildagliptin

Interventions

vildagliptin + acarboseDRUG

4 week treatment

vildagliptin treatment first, acarbose treatment second
acarbose + vildagliptinDRUG

4 week treatment

acarbose treatment first, vildagliptin treatment second

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 24485397DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinAcarbose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • C.J. Tack, MD, PhD, Prof. of Diabetology

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 23, 2009

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

November 5, 2010

Record last verified: 2009-10

Locations

NL(1)