Type 2 DiabetesPhase 3NCT01000688
Vildagliptin and Endothelium-dependent Vasodilatation
A Phase 3 study testing vildagliptin + acarbose and acarbose + vildagliptin in people with Type 2 Diabetes and Endothelial Dysfunction, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Endothelial Dysfunction
- What is being tested?
- vildagliptin + acarbose and acarbose + vildagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2010to Oct 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Age 35-75 years
- Treatment with metformin monotherapy or metformin combination therapy
- HbA1c <8.0%
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
Official title: The Effect of Vildagliptin on Endothelium-dependent Vasodilatation. A Double Blind Cross-over Study in Type 2 Diabetes Mellitus.
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.
- Conditions
- Type 2 Diabetes, Endothelial Dysfunction
- Being tested
- vildagliptin + acarbose, acarbose + vildagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vildagliptin + acarboseDrug
4 week treatment
acarbose + vildagliptinDrug
4 week treatment
| Study group | Role | What they receive |
|---|---|---|
| vildagliptin treatment first, acarbose treatment second | Experimental | Not described Receives: Drug: vildagliptin + acarbose |
| acarbose treatment first, vildagliptin treatment second | Experimental | Not described Receives: Drug: acarbose + vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm vasodilator response to intra-arterial infusion of acetylcholine (endothelium-dependent) following treatment with vildagliptin and following active control with acarbose
Measured: 8 weeks
Secondary outcomes (3)
Effect of vildagliptin on inflammatory markers and adipokines
Measured: 8 weeks
Effect of vildagliptin on fat cell morphology and gene expression
Measured: 8 weeks
Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- C.J. Tack, MD, PhD, Prof. of Diabetology, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000688
- Sponsor's protocol ID
- VILD1
- Status last verified
- Oct 2009
- First submitted
- 21 Oct 2009
- Last updated
- 5 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vildagliptin on Endothelium-dependent Vasodilatation. A Double Blind Cross-over Study in Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT01000688
- Acronym / sponsor ID
- VILD1
- Conditions
- Type 2 Diabetes, Endothelial Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vildagliptin treatment first, acarbose treatment second | Experimental | Drug: vildagliptin + acarbose |
| acarbose treatment first, vildagliptin treatment second | Experimental | Drug: acarbose + vildagliptin |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- Age 35-75 years
- Treatment with metformin monotherapy or metformin combination therapy
- HbA1c <8.0%
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vildagliptin + acarbose4 week treatment | Drug | vildagliptin treatment first, acarbose treatment second |
| acarbose + vildagliptin4 week treatment | Drug | acarbose treatment first, vildagliptin treatment second |
Primary outcome
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
3 secondary outcomes
Effect of vildagliptin on inflammatory markers and adipokines
Time frame: 8 weeks
Effect of vildagliptin on fat cell morphology and gene expression
Time frame: 8 weeks
Effect of vildagliptin on ex vivo mononuclear cell responses to various stimuli
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2010.
- Derived from this study: PubMed 24485397van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C.J. Tack, MD, PhD, Prof. of Diabetology principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vildagliptin + acarbose and acarbose + vildagliptin in people with Type 2 Diabetes and Endothelial Dysfunction, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2010.