Evidence map›Paper›PMID 26378978›Full record

Trial reportThe New England journal of medicine2015

Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes.

Bernard Zinman, Christoph Wanner, John M Lachin, David Fitchett, Erich Bluhmki, Stefan Hantel, Michaela Mattheus, Theresa Devins, Odd Erik Johansen, Hans J Woerle and 3 more

33 registry-linked trialsOpen access · bronzeAbstract 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. It is linked to 33 registered trials, which are not on this map. Cited by 5,250 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5,250citing papers in PubMed, 10 pooled it
622.5field-weighted citation impact, top 1% 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.

NCT02964585 phase4completedstarted 2016, after this paper: background citation

Role of Canagliflozin on Gene Expression and Function of CD34+ Endothelial Progenitor Cells and Renal Function in Patients With Type 2 Diabetes

Ran2016Enrolled34Registered outcomes18Posted comparisons0ConditionsType 2 Diabetes MellitusArmsCanagliflozin, Placebo
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NCT03151343 phase3completedstarted 2017, after this paper: background citation

Effects of SGLT-2 Inhibitor on Myocardial Perfusion, Function and Metabolism in Type 2 DM Patients at High Cardiovascular Risk: The SIMPle Randomized Clinical Trial

Ran2017Enrolled92Registered outcomes22Posted comparisons0ConditionsType2 Diabetes MellitusArmsempagliflozin, Placebo Oral Tablet
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NCT03173963 phase3withdrawnstarted 2017, after this paper: background citation

Empagliflozin in Early Diabetic Kidney Disease

Ran2017Enrolled0Registered outcomes4Posted comparisons0ConditionsDiabetes Mellitus Type 2, Diabetic Kidney DiseaseArmsempagliflozin, Placebo
PMID 27299675PMID 10361863other papers from this trial
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NCT03200860 phase2completedstarted 2017, after this paper: background citation

Randomized, Double Blind, Placebo Controlled, Multicenter Pilot Study on the Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure (EMPA-RESPONSE-AHF)

Ran2017Enrolled80Registered outcomes8Posted comparisons6ConditionsHeart Failure Acute, Heart Failure,Congestive, Heart Failure; With DecompensationArmsempagliflozin 10 mg, Placebo Oral Tablet
PMID 27299675other papers from this trial
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NCT03485092 phase4completedstarted 2018, after this paper: background citation

Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects in Patients With Diabetes Mellitus (or Pre-diabetes) and Heart Failure (SUGAR-DM-HF)

Ran2018Enrolled105Registered outcomes28Posted comparisons0ConditionsDiabetes Mellitus, Heart FailureArmsempagliflozin 10 mg, Placebo Oral Tablet
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NCT03887416 phase4unknown statusstarted 2019, after this paper: background citation

Effect of Dapagliflozin on Nighttime Blood Pressure in Type 2 Diabetes

Ran2019Enrolled225Registered outcomes4Posted comparisons0ConditionsType2 DiabetesArmsDapagliflozin 10 MG Oral Tablet [Farxiga], Placebo Oral Tablet
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NCT03912909 phase4unknown statusstarted 2018, after this paper: background citation

Effects of SGLT-2 Inhibition on Sympathetic Nervous System Activity in Humans

Ran2018Enrolled30Registered outcomes7Posted comparisons0ConditionsMetabolic Syndrome, Obesity, Type 2 Diabetes MellitusArmsEmpagliflozin Oral Tablet [Jardiance], Placebo Oral Tablet
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NCT03917758 naunknown statusstarted 2018, after this paper: background citation

Assessment of the Renin-angiotensin-aldosterone System (RAAS) and Antidiuretic Function in Patients With Type 2 Diabetes Before and During Treatment With Sodium-glucose Co-transporter 2 Inhibitors (SGLT2i): the GliRACo 1 Study

Ran2018Enrolled30Registered outcomes24Posted comparisons0ConditionsArterial Hypertension, Body Weight Changes, Diabetes Mellitus, Type 2ArmsSGLT2 inhibitor
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NCT04131582 phase3unknown statusstarted 2019, after this paper: background citation

Effect of a Quadruple Therapy on Pancreatic Islet Function, Insulin Resistance and Cardiovascular Function in Patients With Mixed Prediabetes and Obesity: Randomized Clinical Trial

Ran2019Enrolled34Registered outcomes4Posted comparisons0ConditionsInsulin Resistance, Prediabetic StateArmsLinagliptin + metformin and Empagliflozin + metformin, Metformin
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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
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NCT04215445 phase4unknown statusstarted 2019, after this paper: background citation

Effect of Sodium Glucose co Transporter 2 (SGLT2) Inhibition on Optical Coherence Tomography Angiography (OCT-A) Parameters in Diabetic Chronic Kidney Disease (CKD)

Ran2019Enrolled90Registered outcomes3Posted comparisons0ConditionsChronic Kidney Diseases, Diabetes Mellitus, Diabetic RetinopathyArmsempagliflozin 25 mg, OCT-A
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NCT04271189 phase3completedstarted 2020, after this paper: background citation

A Prospective, Randomized, Parallel-group, Adaptive Design Phase IIb/III, Multicenter Study, to Assess the Efficacy of Polychemotherapy for Inducing Remission of Newly Diagnosed Type 2 Diabetes.

Ran2020Enrolled108Registered outcomes10Posted comparisons0ConditionsNewly Diagnosed Type 2 DiabetesArmsMetformin-Sitagliptin-Empaglifozin-Pioglitazone, Standard of care
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NCT04717986 nacompletedstarted 2021, after this paper: background citation

Dapagliflozin Effects on Mayor Adverse Cardiovascular Events in Patients With Acute Myocardial Infarction (DAPA-AMI). Randomized Clinical Trial

Ran2021Enrolled188Registered outcomes5Posted comparisons0ConditionsAcute Myocardial Infarction, Angina, Unstable, Cardiovascular Morbidity, Heart FailureArmsDapagliflozin 10mg Tab, Placebo
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NCT04739215 phase4unknown statusstarted 2021, after this paper: background citation

Effects of Sodium-Glucose Cotransporter 2 Inhibition on the Mechanisms of Cardiac Damage in the Diabetic Patient With Heart Failure With Preserved Ejection Fraction

Ran2021Enrolled62Registered outcomes10Posted comparisons0ConditionsDiabetes Mellitus, Type 2, Heart Failure With Preserved Ejection FractionArmsDapagliflozin 10 MG [Farxiga], Placebo
PMID 21329845PMID 28402411PMID 23743396other papers from this trial
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NCT05136287 completedstarted 2022, after this paper: background citation

Semaglutide versus glp-1 receptor agonists. effectiveness , safety and quality of life in patients with diabetes mellitus 2. observational, prospective and multicenter study. several study.

Ran2022Enrolled140Registered outcomes7Posted comparisons0ConditionsDiabetes Mellitus, Type 2, Quality of Life, Safety Issues, Weight LossArmsGLP-1 receptor agonist
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NCT05741658 phase4completedstarted 2023, after this paper: background citation

An Open-Label, Non-randomized, Multi-center Pilot Study to Evaluate the Safety and Efficacy of 4-week, Daily Oral Use of Dapagliflozin 10mg Tablet in Adults With a Fontan Circulation

Ran2023Enrolled29Registered outcomes8Posted comparisons0ConditionsHeart FailureArmsDapagliflozin 10mg Tab
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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
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NCT06706791 phase4recruitingstarted 2025, after this paper: background citation

Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II

Ran2025Enrolled156Registered outcomes2Posted comparisons0ConditionsChronic Heart FailureArmsempagliflozin 10 mg
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NCT07020377 phase1 / phase2active not recruitingstarted 2024, after this paper: background citation

The Hepato-protective Effect of Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)

Ran2024Enrolled60Registered outcomes6Posted comparisons0ConditionsDiabetes Mellitus, Non Alcholic Fatty Liver DiseaseArmsDapagliflozin (DAPA), Negative control, Placebo
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NCT07465926 completedstarted 2017, after this paper: background citation

Associations of Early Add-On GLP-1 Receptor Agonist and SGLT2 Inhibitor Therapy With Mortality and Kidney Outcomes in Adults With Obesity and Type 2 Diabetes Across Cardiovascular-Kidney-Metabolic Stages 2-3: A Target-Trial Emulation

Ran2017Enrolled451,036Registered outcomes12Posted comparisons0ConditionsCardiovascular Disease Risk Factor, Cardiovascular-kidney-metabolic Syndrome, Kidney Disease, Obesity & OverweightArmsGLP-1 receptor agonist, SGLT2 inhibitor
Open the trial in the graph
NCT01131676 phase3completednot on this map

A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

TypeinterventionalSponsorBoehringer IngelheimRan2010 to 2015Enrolled7,064ConditionsDiabetes Mellitus, Type 2ArmsBI 10773 low dose, Placebo BI 10773 high dose, BI 10773 high dose, Placebo BI 10773 low dose
NCT03717194 phase3completednot on this mapstarted 2019, after this paper: background citation

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, to Evaluate the Effect of Ertugliflozin on Cardiac Function in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control and Stage B Heart Failure

TypeinterventionalSponsorSoo LimRan2019 to 2023Enrolled102ConditionsType2 Diabetes, Heart FailureArmsErtugliflozin, Placebo
NCT03878706 recruitingnot on this mapstarted 2017, after this paper: background citation

The Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination on Endothelial Function, Arterial Stiffness and Left Ventricular Deformation in Patients With Type 2 Diabetes With High Cardiovascular Risk

Typeobservational_patient_registrySponsorUniversity of AthensRan2017 to 2027Enrolled240ConditionsDiabetes Mellitus, Type 2
NCT03965000 unknown statusnot on this mapstarted 2019, after this paper: background citation

Human SLC5A2 Deficiency and the Glucagon-Incretin Axis: A Pilot Study

TypeobservationalSponsorMedical University InnsbruckRan2019 to 2022Enrolled10ConditionsFamilial Renal Glucosuria, Diabetes Mellitus, Cardiovascular DiseasesArmsMixed-meal-tolerance-test
NCT04780438 early_phase1unknown statusnot on this mapstarted 2021, after this paper: background citation

Dapagliflozin to Prevent Atrial Fibrillation Recurrence After Transcatheter Pulmonary Venous Isolation.

TypeinterventionalSponsorG.Gennimatas General HospitalRan2021 to 2023Enrolled350ConditionsAtrial Fibrillation Recurrent, Pulmonary Venous Isolation, Catheter Ablation, Sodium-glucose Co-transporter 2 InhibitorsArmsDapagliflozin, Placebo
NCT05047471 unknown statusnot on this mapstarted 2021, after this paper: background citation

Healthy China - The Improvement Projects for the Screening Ability of Diabetes and Its Complications And for the Standardized Ability of Diagnosis and Treatment for Patients With Early Diabetic Nephropathy

TypeobservationalSponsorYiming MuRan2021 to 2023Enrolled10,000ConditionsDiabetic Kidney Disease
NCT05349955 narecruitingnot on this mapstarted 2022, after this paper: background citation

Effects and Safety of GUideline Algorithm Based Intervention on CaRdiovascular and Renal Outcomes in Elderly Diabetic Patients With High Cardiovascular Risk in the Community- A Cluster Randomized Controlled Trial (GUARD-Community Study)

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2022 to 2026Enrolled5,600ConditionsType 2 Diabetes, Cardiovascular Complication, Diabetic Kidney DiseaseArmsIntensive guideline algorithm implementation, Conventional guideline algorithm implementation
NCT05424315 phase2 / phase3completednot on this mapstarted 2021, after this paper: background citation

Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients - DACAMI (a Randomized Controlled Clinical Trial)

TypeinterventionalSponsorOmar YounisRan2021 to 2022Enrolled100ConditionsAnterior MIArmsDapagliflozin 10mg, Glucose Tab
NCT06143566 phase1 / phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Polypill Strategy for Prevention of Cardiomyopathy Among Patients With Diabetes at Risk of Heart Failure

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2024 to 2027Enrolled200ConditionsType 2 Diabetes, High Blood PressureArmsPolypill, Combined prescription of the individual medications
NCT06473844 narecruitingnot on this mapstarted 2025, after this paper: background citation

Efficacy and Safety of Sodium-Glucose Cotransporter 2 Inhibitors in Adults With Sepsis: A Feasibility Study for a Multicenter Double-Blind Randomized Placebo-Controlled Trial

TypeinterventionalSponsorHospital Authority, Hong KongRan2025 to 2027Enrolled60ConditionsSepsis, Inflammation, SGLT2 Inhibitors, Critically IllArmsEmpagliflozin 10 MG, Placebo
NCT06838507 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Incidence, Characterisation and Outcome-relevance of Perioperative SGLT2 Inhibitor Associated Ketoacidosis - A Multicentre Prospective Cohort Study

TypeobservationalSponsorHeinrich-Heine University, DuesseldorfRan2025 to 2026Enrolled2,000ConditionsSGLT2 Inhibitor, Ketoacidosis, Eugylcemic
NCT07566299 completednot on this mapstarted 2017, after this paper: background citation

Early GLP-1 Receptor Agonist and SGLT2 Inhibitor Add-On Strategies in Adults With Obesity, Type 2 Diabetes, Cardiovascular-Kidney-Metabolic Syndrome Stage 2-3, and Metabolic Dysfunction-Associated Steatotic Liver Disease: A Target Trial Emulation

TypeobservationalSponsorChung Shan Medical UniversityRan2017 to 2026Enrolled118,805ConditionsObesity Type 2 Diabetes Mellitus, Cardiovascular-kidney-metabolic Syndrome, Metabolic Dysfunction-Associated Steatotic Liver Disease
NCT07719621 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Implication of Albuminuria Reduction and Other Cardiorenal Effects on The Risk of Heart Failure in Patients With CKD and T2D

TypeobservationalSponsorAeterna Medical Solutions SLRan2026 to 2026Enrolled50,000ConditionsCKD - Chronic Kidney Disease, Diabetes Mellitus Type 2
3 · Its place in the literature

Who cites it

5,250 citing papers in PubMed, 10 syntheses or guidelines pooled it, 11,756 citations in OpenAlex.

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  14. Empagliflozin in STEMI Patients: A Randomized Controlled Trial on Left Ventricular Recovery and Cardiovascular Outcomes.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026
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5,190 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 5 countries.

Bernard ZinmanFrom the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital (B.Z.) and the Divisions of Endocrinology (B.Z.) and Cardiology (D.F.), University of Toronto - all in Toronto; the Department of Medicine, Division of Nephrology, Würzburg University Clinic, Würzburg (C.W.), Boehringer Ingelheim Pharma, Biberach (E.B., S.H.), and Boehringer Ingelheim Pharma, Ingelheim (M.M., H.J.W., U.C.B.) - all in Germany; the Biostatistics Center, George Washington University, Rockville, MD (J.M.L.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (T.D.); Boehringer Ingelheim Norway, Asker, Norway (O.E.J.); and the Section of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.).
Christoph Wanner
John M Lachin
David Fitchett
Erich Bluhmki
Stefan Hantel
Michaela Mattheus
Theresa Devins
Odd Erik Johansen
Hans J Woerle
Uli C Broedl
Silvio E Inzucchi
EMPA-REG OUTCOME Investigators
Boehringer Ingelheim (Taiwan) · TWBoehringer Ingelheim (Germany) · DEBoehringer Ingelheim (Norway) · NOBoehringer Ingelheim (United States) · USGeorge Washington University · USLunenfeld-Tanenbaum Research Institute · CAUniversity of Toronto · CAUniversity of Würzburg · DEYale University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known.

methodsWe randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group. The key secondary composite outcome was the primary outcome plus hospitalization for unstable angina.

resultsA total of 7020 patients were treated (median observation time, 3.1 years). The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P=0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction). There was no significant between-group difference in the key secondary outcome (P=0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events.

conclusionsPatients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care. (Funded by Boehringer Ingelheim and Eli Lilly; EMPA-REG OUTCOME ClinicalTrials.gov number, NCT01131676.).

Indexed as

AgedBenzhydryl CompoundsCardiovascular DiseasesCause of DeathDiabetes Mellitus, Type 2FemaleGlucosidesHospitalizationHumansHypoglycemic AgentsIntention to Treat AnalysisKaplan-Meier EstimateMaleMiddle AgedRisk FactorsBenzhydryl CompoundsempagliflozinGlucosidesHypoglycemic Agents

Identifiers

PMID26378978
OpenAlexW2146264128

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

and 27 more above

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.