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Type 2 Diabetes MellitusPhase 4VAASTNCT01604213

Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease

A Phase 4 study testing Metformin plus vildagliptin and Metformin only in people with Type 2 Diabetes Mellitus and Ischemic Heart Disease, run by Sheba Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to demonstrate that combined vildagliptin-metformin therapy is associated with clinically significant reductions in biological markers of inflammation, pro-thrombogenicity, and atherosclerosis as compared to metformin mono-therapy in a population of diabetic patients with coronary artery… Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Metformin plus vildagliptin and Metformin only
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIsrael
Study dates
Sep 2012to Apr 2016
Phase
Phase 4
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 Diabetes Mellitus on oral mono-therapy or diet only treatment
  • Stable documented ischemic Heart disease (>30 days post AMI, CABG or PCI)
  • Sub-optimal Hb A1c as defined ≥6.5%
  • Age > 21
  • Life expectancy >1 year

Who cannot join

  • Significant renal impairment (creatinine ≥1.4 mg\dL females or ≥1.5 mg\dL males)
  • Planned coronary intervention or planed surgical intervention (PCI or CABG)
  • Planned surgical intervention
  • Recent (<30 day) acute coronary syndrome (ACS)
  • Hypersensitivity to either of the study drug components
  • History of lactic acidosis
Show all 18Show fewer
  • Type I diabetes
  • Current Hb A1c >9%
  • Current Insulin treatment
  • Active treatment with GLP-1 or DPP4i medication
  • Hepatic impairment or ALT\AST elevations beyond X2 upper normal limit or known hepatic failure
  • Inability to comply with study protocol
  • Active malignancy other than basal cell carcinoma (BCC)
  • Clinically advanced congestive heart failure - NYHA III-IV
  • Severe left ventricular dysfunction (LVEF<30%) with NYHA II or any NYHA class with documented recent heart failure decompensation (<3 months)
  • Severe stable cardiac angina CCS III - IV or Unstable angina
  • Chronic inflammation (i.e. IBD, Lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection)
  • Pregnancy, lactation or child-bearing potential

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Sheba Medical Center, Cardiac Rehabilitation Institute

    Tel HaShomer, 52621

Other trials in Israel

About this study

Official title: Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetic Patients With Coronary Artery Disease

The purpose of this study is to demonstrate that combined vildagliptin-metformin therapy is associated with clinically significant reductions in biological markers of inflammation, pro-thrombogenicity, and atherosclerosis as compared to metformin mono-therapy in a population of diabetic patients with coronary artery disease who undergo cardiac rehabilitation.

The pre-specified established biological markers of inflammation, pro-thrombogenicity, and atherosclerosis will include: interleukin-6 (IL-6 - primary biological marker), hs-CRP, platelet reactivity testing, MMP-9, Interleukin 1 beta (IL-1 beta) and adiponectin levels.

Read the detailed description

The study is designed as a single-center, randomized, non-blinded, clinical trial to provide evidence on the effects of vildagliptin on key biomarkers of atherothrombosis and inflammation. We plan to prospectively enroll 60 patients with proven coronary artery disease and randomize them in a 2:1 ratio to either vildagliptin-metformin therapy (n=40) or metformin therapy (n=20).

Being tested
Metformin plus vildagliptin, Metformin only
Keywords
Type 2 diabetes mellitus, vildagliptin, metformin, atherosclerosis, inflammation, interleukin-6, TNF, atherothrombosis, adiponectin, MMP-9, hs-CRP
Medical subject headings
Diabetes Mellitus, Type 2, Myocardial Ischemia, Atherosclerosis, Inflammation, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin plus vildagliptinDrug

    Also called Eucreas

    Oral Metformin 850mg and vildagliptin 50mg, qd initially, up-titrated to BID if clinically necessary

  • Metformin onlyDrug

    Oral Metformin 850mg QD, up-titrated to 850mg TID is clinically indicated

Study groups in NCT01604213
Study groupRoleWhat they receive
Vildagliptin+metforminExperimentalOral Vildagliptin+metformin combination
Receives: Drug: Metformin plus vildagliptin
Metformin onlyActive comparatorOral metformin only
Receives: Drug: Metformin only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in serum levels of Interleukin 6 (IL-6)

    Measured: 3 months

Secondary outcomes (1)

  1. Improvement in other markers of athero-thrombosis and inflammation:

    1. Improvement in other markers of athero-thrombosis and inflammation:
    2. High sensitivity C-reactive protein (hs-CRP),
    3. Platelet reactivity
    4. Adiponectin levels
    5. IL-1 beta
    6. Matrix metallo-peptidase 9 (MMP-9)
    7. Additional exploratory markers including: IL-1 alpha ,, IL-17, TNF-alpha, MCP-1

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01604213
Sponsor's protocol ID
SHEBA-12-9455-RK-CTIL
Acronym
VAAST
Status last verified
Apr 2016
First submitted
21 May 2012
Last updated
19 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Shah Z, Kampfrath T, Deiuliis JA, Zhong J, Pineda C, Ying Z, Xu X, Lu B, Moffatt-Bruce S, Durairaj R, Sun Q, Mihai G, Maiseyeu A, Rajagopalan S. Long-term dipeptidyl-peptidase 4 inhibition reduces atherosclerosis and inflammation via effects on monocyte recruitment and chemotaxis. Circulation. 2011 Nov 22;124(21):2338-49. doi: 10.1161/CIRCULATIONAHA.111.041418. Epub 2011 Oct 17.

    PubMed 22007077

  • Goossen K, Graber S. Longer term safety of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes mellitus: systematic review and meta-analysis. Diabetes Obes Metab. 2012 Dec;14(12):1061-72. doi: 10.1111/j.1463-1326.2012.01610.x. Epub 2012 May 17.

    PubMed 22519906

  • Zoungas S, Patel A, Chalmers J, de Galan BE, Li Q, Billot L, Woodward M, Ninomiya T, Neal B, MacMahon S, Grobbee DE, Kengne AP, Marre M, Heller S; ADVANCE Collaborative Group. Severe hypoglycemia and risks of vascular events and death. N Engl J Med. 2010 Oct 7;363(15):1410-8. doi: 10.1056/NEJMoa1003795.

    PubMed 20925543

  • Jenny NS, Brown ER, Detrano R, Folsom AR, Saad MF, Shea S, Szklo M, Herrington DM, Jacobs DR Jr. Associations of inflammatory markers with coronary artery calcification: results from the Multi-Ethnic Study of Atherosclerosis. Atherosclerosis. 2010 Mar;209(1):226-9. doi: 10.1016/j.atherosclerosis.2009.08.037. Epub 2009 Aug 28.

    PubMed 19766217

  • Derosa G, Maffioli P, Ferrari I, Mereu R, Ragonesi PD, Querci F, Franzetti IG, Gadaleta G, Ciccarelli L, Piccinni MN, D'Angelo A, Salvadeo SA. Effects of one year treatment of vildagliptin added to pioglitazone or glimepiride in poorly controlled type 2 diabetic patients. Horm Metab Res. 2010 Aug;42(9):663-9. doi: 10.1055/s-0030-1255036. Epub 2010 Jun 17.

    PubMed 20560108

  • Younis A, Eskenazi D, Goldkorn R, Leor J, Naftali-Shani N, Fisman EZ, Tenenbaum A, Goldenberg I, Klempfner R. The addition of vildagliptin to metformin prevents the elevation of interleukin 1ss in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study. Cardiovasc Diabetol. 2017 May 22;16(1):69. doi: 10.1186/s12933-017-0551-5.

    PubMed 28532406

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin plus vildagliptin and Metformin only in people with Type 2 Diabetes Mellitus and Ischemic Heart Disease, run by Sheba Medical Center at 1 site in Israel.

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 5 inclusion and 18 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 19 Apr 2016. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Reduction in serum levels of Interleukin 6 (IL-6) (time frame: 3 months). 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 NCT01604213, which also lists 6 linked publications.

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 19 Apr 2016.

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