Evidence map›Paper›PMID 26052984›Full record

Trial reportThe New England journal of medicine2015

Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes.

Jennifer B Green, M Angelyn Bethel, Paul W Armstrong, John B Buse, Samuel S Engel, Jyotsna Garg, Robert Josse, Keith D Kaufman, Joerg Koglin, Scott Korn and 10 more

Erratum issued 5 registry-linked trialsAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 5 registered trials, which are not on this map. Cited by 1,026 papers, 25 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,026citing papers in PubMed, 25 pooled it
–field-weighted citation impact
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.

NCT04183868 phase4completedstarted 2016, after this paper: background citation

Comparative Effects of Empagliflozin Versus Glimepiride After 26-weeks of Treatment Add on Metformin on Myocardial Metabolic Rate of Glucose Estimated Through 18FDG-PET in Patients With Type 2 Diabetes

Ran2016Enrolled26Registered outcomes10Posted comparisons0ConditionsCardiovascular Risk Factor, Type 2 DiabetesArmsempagliflozin 10 mg, Glimepiride 2 mg
PMID 24929430PMID 24463454PMID 26378978PMID 26343814PMID 25791290PMID 25537706PMID 25271206PMID 23404920PMID 22357182PMID 21606218PMID 11511119PMID 9742976other papers from this trial
Open the trial in the graph
NCT06286878 phase2 / phase3recruitingstarted 2021, after this paper: background citation

Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes

Ran2021Enrolled80Registered outcomes4Posted comparisons0ConditionsAcute Coronary Syndrome, Diabetes, Myocardial Infarction, Ventricular DysfunctionArmsdapagliflozin, Placebo
PMID 14502100PMID 28605608PMID 21205121PMID 26026848PMID 27295427PMID 28522450PMID 11602624PMID 11595605PMID 24026259PMID 23992602PMID 23992601PMID 23598457other papers from this trial
Open the trial in the graph
NCT00790205 phase3completednot on this map

TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2008 to 2015Enrolled14,671ConditionsType 2 Diabetes MellitusArmsSitagliptin, Placebo
NCT02377388 phase3completednot on this mapstarted 2017, after this paper: background citation

DPP-4 Inhibitors in Patients With Type 2 Diabetes and Acute Myocardial Infarction:Effects on Platelet Function

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2017 to 2020Enrolled74ConditionsPlatelet Aggregation During Acute Myocardial InfarctionArmssitagliptin OR saxagliptin, placebo
NCT04231838 naunknown statusnot on this mapstarted 2021, after this paper: background citation

A Randomised Controlled International Multicentre Study Evaluating Changes in Metabolic Syndrome in Smokers With Type 2 Diabetes Mellitus After Switching From Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems: DIASMOKE Study

TypeinterventionalSponsorEclat Srl.Ran2021 to 2026Enrolled576ConditionsCardiovascular Risk Factor, Diabetes Mellitus, Type 2ArmsTOBACCO CIGARETTES, COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)
3 · Its place in the literature

Who cites it

1,026 citing papers in PubMed, 25 syntheses or guidelines pooled it.

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  20. Effects of newer-generation anti-diabetics on diabetic retinopathy: a critical review.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Pooled it

966 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Jennifer B GreenFrom the Duke Clinical Research Institute, Duke University School of Medicine, Durham (J.B.G., J.G., M.J.P., E.D.P.) and University of North Carolina School of Medicine, Chapel Hill (J.B.B.) - both in North Carolina; Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, United Kingdom (M.A.B., R.R.H.); Canadian VIGOUR Centre, University of Alberta, Edmonton, AB (P.W.A.) and St. Michael's Hospital, University of Toronto, Toronto (R.J.) - both in Canada; Merck, Kenilworth, NJ (S.S.E., K.D.K., J.K., S.K., P.P.S., S.S.); George Washington University Biostatistics Center, Rockville, MD (J.M.L.); University of Texas Southwestern Medical Center, Dallas (D.K.M.); Munich Diabetes Research Group, Helmholtz Center, Neuherberg, Germany (E.S.); and University of Leuven, Leuven, Belgium (F.V.W.).
M Angelyn Bethel
Paul W Armstrong
John B Buse
Samuel S Engel
Jyotsna Garg
Robert Josse
Keith D Kaufman
Joerg Koglin
Scott Korn
John M Lachin
Darren K McGuire
Michael J Pencina
Eberhard Standl
Peter P Stein
Shailaja Suryawanshi
Frans Van de Werf
Eric D Peterson
Rury R Holman
TECOS Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundData are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease.

methodsIn this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina.

resultsDuring a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to -0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P<0.001). Rates of hospitalization for heart failure did not differ between the two groups (hazard ratio, 1.00; 95% CI, 0.83 to 1.20; P=0.98). There were no significant between-group differences in rates of acute pancreatitis (P=0.07) or pancreatic cancer (P=0.32).

conclusionsAmong patients with type 2 diabetes and established cardiovascular disease, adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalization for heart failure, or other adverse events. (Funded by Merck Sharp & Dohme; TECOS ClinicalTrials.gov number, NCT00790205.).

Indexed as

Administration, OralCardiovascular DiseasesDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFollow-Up StudiesGlycated HemoglobinHeart DiseasesHeart FailureHospitalizationHumansHypoglycemic AgentsKaplan-Meier EstimatePyrazinesSitagliptin PhosphateTriazolesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsPyrazinesSitagliptin PhosphateTriazoles

Identifiers

PMID26052984

What OpenQuestion holds

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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 OpenQuestion graph.