Evidence mapPaperPMID 28532406Full record

Trial reportCardiovascular diabetology2017

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.

Arwa Younis, Dana Eskenazi, Ronen Goldkorn, Jonathan Leor, Nili Naftali-Shani, Enrique Z Fisman, Alexander Tenenbaum, Ilan Goldenberg, Robert Klempfner

2 registry-linked trialsOpen access · goldFull text readRandomized Controlled Trial
In one paragraph

Trial report in Cardiovascular diabetology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01604213. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 pooled it
2.8field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01604213 phase4completed

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

Ran2012Enrolled60Registered outcomes2Posted comparisons0ConditionsIschemic Heart Disease, Type 2 Diabetes MellitusArmsMetformin only, Metformin plus vildagliptin
Open the trial in the graph
NCT03693560 phase4completedstarted 2018, after this paper: background citation

The Effect of Adding Vildagliptin Versus Glimepiride to Metformin on Markers of Inflammation, Thrombosis, and Atherosclerosis in Diabetic Patients With Symptomatic Coronary Artery Diseases

Ran2018Enrolled80Registered outcomes7Posted comparisons0ConditionsCoronary Artery Disease, Diabetes Mellitus, Type 2ArmsGlimepiride upto 4 mg Oral Tablet, Metformin 1000 mg Oral Tablet, Vildagliptin 50 mg Oral Tablet
Open the trial in the graph
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Impact of DPP-4 Inhibitors on Interleukin Levels in Type 2 Diabetes Mellitus.The Journal of clinical endocrinology and metabolism · 2025
    Pooled it
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  5. Review
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  11. Vasculoprotective Effects of Vildagliptin. Focus on Atherogenesis.International journal of molecular sciences · 2020
    Review
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  13. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Arwa YounisThe Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sheba Road 2, 52620, Ramat Gan, Israel. or.younis@gmail.com.
Dana EskenaziSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Ronen GoldkornThe Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sheba Road 2, 52620, Ramat Gan, Israel.
Jonathan LeorThe Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sheba Road 2, 52620, Ramat Gan, Israel.
Nili Naftali-ShaniThe Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sheba Road 2, 52620, Ramat Gan, Israel.
Enrique Z FismanSackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Alexander TenenbaumThe Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sheba Road 2, 52620, Ramat Gan, Israel.
Ilan GoldenbergThe Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sheba Road 2, 52620, Ramat Gan, Israel.
Robert KlempfnerThe Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sheba Road 2, 52620, Ramat Gan, Israel.
Sheba Medical Center · ILTel Aviv University · ILUniversity of Rochester · US

Funding

MEDICAL SCIENTIST TRAINING PROGRAMT32GM007266 · UNIVERSITY OF WASHINGTON · 1985 to 2005
$5.5M
NIGMS NIH HHS T32 GM007266
6 · The paper itself

Abstract

backgroundPatients with type 2 diabetes present with an accelerated atherosclerotic process. Animal evidence indicates that dipeptidyl peptidase-4 inhibitors (gliptins) have anti-inflammatory and anti-atherosclerotic effects, yet clinical data are scarcely available. DESIGN AND

methodsA prospective, randomized, open-label study was performed in 60 patients with coronary artery disease (CAD) and type 2 diabetes, who participated in a cardiac rehabilitation program. After a washout period of 3 weeks, patients were randomized in a 2:1 ratio to receive combined vildagliptin/metformin therapy (intervention group: n = 40) vs. metformin alone (control group: n = 20) for a total of 12 weeks. Blinded assessment of interleukin-1ß (IL-1ß, the primary endpoint), hemoglobin A1c (HbA1c), and high sensitivity C reactive protein (hsCRP), were performed at baseline and after 12 weeks.

resultsMean age of study patients was 67 ± 9 years, 75% were males, and baseline HbA1c and inflammatory markers levels were similar between the two groups. At 12 weeks of follow up, levels of IL-1ß, hsCRP, and HbA1c were significantly lower in the intervention group as compared with the control group. There was a continuous elevation of IL-1ß among the control group, which was not observed in the intervention group (49 vs. 4%, respectively; p < 0.001). The hsCRP was lowered by 60% in the vildagliptin/metformin group vs. 23% in the metformin group (p < 0.01). Moreover, a significant relative reduction of the HbA1c was seen in the intervention group (7% reduction, p < 0.03).

conclusionThe addition of vildagliptin to metformin treatment in patients with type 2 diabetes and CAD led to a significant suppression of the IL-1ß elevation during follow up. A significant relative reduction of hsCRP and HbA1c in the intervention group was also observed. Trial registration NCT01604213.

Indexed as

Cardiac RehabilitationAdamantaneAgedBiomarkersCoronary Artery DiseaseC-Reactive ProteinDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemic AgentsInflammation MediatorsInterleukin-1betaIsraelAdamantaneBiomarkersC-Reactive ProteinDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsIL1B protein, humanInflammation MediatorsInterleukin-1betaMetforminNitrilesPyrrolidinesVildagliptinDipeptidyl peptidase-4 inhibitorsGliptinsInterleukin 1 betaMetforminVildagliptin

Identifiers

PMID28532406
PMCPMC5440983
OpenAlexW2619552711

What Socratic holds

Textfull text, public
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.