Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
16 participants
INTERVENTIONAL
2010-01-31
2010-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
vildagliptin treatment first, acarbose treatment second
vildagliptin + acarbose
4 week treatment
acarbose treatment first, vildagliptin treatment second
acarbose + vildagliptin
4 week treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
vildagliptin + acarbose
4 week treatment
acarbose + vildagliptin
4 week treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 35-75 years
* Treatment with metformin monotherapy or metformin combination therapy
* HbA1c \<8.0%
Exclusion Criteria
* 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
35 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Radboud University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
UMC St Radboud
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
C.J. Tack, MD, PhD, Prof. of Diabetology
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VILD1
Identifier Type: -
Identifier Source: org_study_id