{"id":"empagliflozin-sglt2i","safety":{"boxedWarnings":["WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of"],"drugInteractions":[{"drug":"Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide)","action":"Monitor","effect":"decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis"},{"drug":"Drugs that Reduce Metformin Clearance (e.g., ranolazine, vandetanib, dolutegravir, and cimetidine)","action":"Adjust dose","effect":"increase systemic exposure to metformin and may increase the risk for lactic acidosis"},{"drug":"Alcohol","action":"Avoid","effect":"potentiate the effect of metformin on lactate metabolism"},{"drug":"Diuretics","action":"Monitor","effect":"increased urine volume and frequency of voids, which might enhance the potential for volume depletion"},{"drug":"Insulin or Insulin Secretagogues (e.g., sulfonylurea)","action":"Adjust dose","effect":"increase the risk of hypoglycemia"},{"drug":"Drugs Affecting Glycemic Control (e.g., thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid)","action":"Monitor","effect":"produce hyperglycemia and may lead to loss of glycemic control"},{"drug":"Lithium","action":"Monitor","effect":"decrease serum lithium concentrations"},{"drug":"Drugs that Reduce Metformin Clearance (e.g., ranolazine, vandetanib, dolutegravir, and cimetidine)","action":"Adjust dose","effect":"increase systemic exposure to metformin and may increase the risk for lactic acidosis"}],"commonSideEffects":[{"effect":"Urinary tract infection","drugRate":"7.6%","severity":"mild"},{"effect":"Female genital mycotic infections","drugRate":"5.4%","severity":"mild"},{"effect":"Upper respiratory tract infection","drugRate":"3.8%","severity":"mild"},{"effect":"Increased urination","drugRate":"3.4%","severity":"mild"},{"effect":"Dyslipidemia","drugRate":"3.9%","severity":"mild"},{"effect":"Arthralgia","drugRate":"2.4%","severity":"mild"},{"effect":"Male genital mycotic infections","drugRate":"3.1%","severity":"mild"},{"effect":"Nausea","drugRate":"2.3%","severity":"mild"},{"effect":"Volume Depletion","drugRate":"0.5%","severity":"serious"},{"effect":"Hypotension","drugRate":"0.3%","severity":"serious"},{"effect":"Hypovolemia","drugRate":"0.3%","severity":"serious"},{"effect":"Orthostatic hypotension","drugRate":"0.3%","severity":"serious"},{"effect":"Syncope","drugRate":"0.3%","severity":"serious"},{"effect":"Nocturia","drugRate":"0.8%","severity":"mild"},{"effect":"Polyuria","drugRate":"3.4%","severity":"mild"},{"effect":"Pollakiuria","drugRate":"3.4%","severity":"mild"},{"effect":"Hypoglycemia","drugRate":"9.8%","severity":"mild"},{"effect":"Lactic Acidosis","drugRate":"0%","severity":"serious"}],"contraindications":["severe renal impairment (eGFR less than 30 mL/min/1.73 m^2)","acute or chronic metabolic acidosis, including diabetic ketoacidosis","hypersensitivity to empagliflozin, metformin HCl or any of the excipients in SYNJARDY or SYNJARDY XR, reactions such as angioedema have occurred"],"specialPopulations":{"Lactation":"Not recommended when breastfeeding. There is limited information regarding the presence of SYNJARDY, SYNJARDY XR, or its components (empagliflozin or metformin HCl) in human milk, the effects on the breastfed infant, or the effects on milk production.","Pregnancy":"Advise females of the potential risk to a fetus especially during the second and third trimesters. SYNJARDY and SYNJARDY XR are not recommended during the second and third trimesters of pregnancy. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.","Geriatric use":"Higher incidence of adverse reactions related to volume depletion and reduced renal function.","Paediatric use":"Not mentioned","Renal impairment":"Higher incidence of adverse reactions related to reduced renal function.","Hepatic impairment":"Avoid use in patients with hepatic impairment."}},"_chembl":null,"company":"Hotel Dieu de France Hospital","timeline":[{"date":"2015-08-26","type":"positive","_source":"FDA NDA206111","milestone":"FDA ORIG — BOEHRINGER INGELHEIM","regulator":"FDA","description":""},{"date":"2015-12-04","type":"positive","_source":"FDA NDA206111","milestone":"FDA SUPPL — BOEHRINGER INGELHEIM","regulator":"FDA","description":""},{"date":"2016-05-06","type":"positive","_source":"FDA NDA206111","milestone":"FDA SUPPL — BOEHRINGER INGELHEIM","regulator":"FDA","description":""},{"date":"2016-12-09","type":"positive","_source":"FDA NDA208658","milestone":"FDA ORIG — BOEHRINGER INGELHEIM","regulator":"FDA","description":""},{"date":"2017-12-13","type":"positive","_source":"FDA NDA208658","milestone":"FDA SUPPL — BOEHRINGER INGELHEIM","regulator":"FDA","description":""},{"date":"2018-10-26","type":"positive","_source":"FDA NDA208658","milestone":"FDA SUPPL — BOEHRINGER INGELHEIM","regulator":"FDA","description":""},{"date":"2020-01-24","type":"positive","_source":"FDA NDA208658","milestone":"FDA SUPPL — BOEHRINGER INGELHEIM","regulator":"FDA","description":""},{"date":"2021-06-11","type":"positive","_source":"FDA NDA208658","milestone":"FDA SUPPL — BOEHRINGER INGELHEIM","regulator":"FDA","description":""},{"date":"2022-03-21","type":"positive","_source":"FDA NDA208658","milestone":"FDA SUPPL — BOEHRINGER INGELHEIM","regulator":"FDA","description":""},{"date":"2023-02-06","type":"positive","_source":"FDA NDA208658","milestone":"FDA SUPPL — BOEHRINGER INGELHEIM","regulator":"FDA","description":""},{"date":"2025-03-07","type":"positive","_source":"FDA NDA208658","milestone":"FDA SUPPL — BOEHRINGER INGELHEIM","regulator":"FDA","description":""}],"_dailymed":null,"aiSummary":"Empagliflozin, developed by Hotel Dieu de France Hospital, is a SGLT2 inhibitor and biguanide combination. It targets Type 2 Diabetes Mellitus, cardiovascular death, and heart failure. Empagliflozin's mechanism involves inhibiting SGLT2, reducing glucose reabsorption, and increasing urinary glucose excretion. This leads to improved glucose tolerance and reduced hepatic glucose production. The drug's clinical differentiation lies in its unique mechanism of action and efficacy in cardiovascular and kidney disease. Empagliflozin's commercial significance is evident in its market presence and revenue. Pipeline developments are not mentioned.","brandName":"Synjardy","isGeneric":true,"mechanism":{"target":"SGLT2","novelty":"best-in-class","modality":"small molecule","drugClass":"SGLT2 inhibitor and biguanide combination","explanation":"Empagliflozin works by inhibiting SGLT2, the predominant transporter responsible for glucose reabsorption in the kidneys. This leads to a reduction in glucose reabsorption and an increase in urinary glucose excretion. As a result, empagliflozin lowers the renal threshold for glucose and improves glucose tolerance in patients with type 2 diabetes mellitus. Additionally, empagliflozin reduces sodium reabsorption and increases the delivery of sodium to the distal tubule, which may influence several physiological functions.","oneSentence":"Empagliflozin is a SGLT2 inhibitor and biguanide combination that targets Type 2 Diabetes Mellitus and cardiovascular disease.","technicalDetail":"Empagliflozin is a SGLT2 inhibitor that works by binding to the SGLT2 transporter and preventing the reabsorption of glucose in the kidneys. This leads to an increase in urinary glucose excretion and a decrease in glucose levels in the blood. Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule, which may lead to a decrease in blood pressure and an improvement in cardiovascular outcomes."},"_scrapedAt":"2026-03-27T23:29:08.654Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"launchDate":"2015","annualCostUS":"Generic pricing varies by manufacturer","_launchSource":"FDA NDA206111 (BOEHRINGER INGELHEIM)","genericStatus":"Generic — off-patent","peakSalesEstimate":"Not publicly reported"},"references":[{"id":1,"url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Empagliflozin (SGLT2i)","fields":["mechanism","safety","indications","administration"],"source":"FDA Drug Label (DailyMed)"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Empagliflozin%20%28SGLT2i%29","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Empagliflozin (SGLT2i)","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":5,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/","fields":["timeline","launchDate"],"source":"FDA Drugs@FDA"},{"id":6,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":7,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_whoChecked":true,"competitors":[{"name":"Canagliflozin (Invokana)","company":"Janssen Pharmaceuticals","advantage":"Has a lower risk of amputations compared to Empagliflozin","genericName":"Canagliflozin"},{"name":"Dapagliflozin (Farxiga)","company":"AstraZeneca","advantage":"Has a broader indication for heart failure treatment","genericName":"Dapagliflozin"},{"name":"Ertugliflozin (Steglatro)","company":"Lilly and Merck","advantage":"Can be used in combination with other medications for better glycemic control","genericName":"Ertugliflozin"},{"name":"Lixisenatide (Soliqua, Adlyxin)","company":"Sanofi","advantage":"Also has a glucagon-like peptide-1 (GLP-1) receptor agonist effect","genericName":"Lixisenatide"},{"name":"Luseogliflozin (Zafzel)","company":"Taisho Pharmaceutical","advantage":"Has a lower risk of hypoglycemia compared to other SGLT2 inhibitors","genericName":"Luseogliflozin"}],"genericName":"empagliflozin (sglt2i)","indications":{"approved":[{"name":"Type 2 Diabetes Mellitus","regulator":"FDA"},{"name":"Cardiovascular (CV) Death in Adults with Established CV Disease","regulator":"FDA"},{"name":"CV Death and Hospitalization for Heart Failure in Adults with Heart Failure","regulator":"FDA"},{"name":"Sustained Decline in eGFR, End-Stage Kidney Disease, CV Death, and Hospitalization in Adults with Chronic Kidney Disease at Risk of Progression","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"trialDetails":[{"nctId":"NCT05138575","phase":"PHASE2","title":"SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial","status":"RECRUITING","sponsor":"University of Pennsylvania","startDate":"2022-01-24","conditions":"Heart Failure With Preserved Ejection Fraction","enrollment":53},{"nctId":"NCT05390892","phase":"PHASE4","title":"PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes","status":"RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2022-09-26","conditions":"Type2Diabetes, ASCVD","enrollment":6000},{"nctId":"NCT07513883","phase":"PHASE4","title":"The Assessment of Partial Guideline-Directed Medical Therapy Down Titration in Heart Failure in Remission.","status":"RECRUITING","sponsor":"Ziekenhuis Oost-Limburg","startDate":"2026-03-16","conditions":"Heart Failure","enrollment":100},{"nctId":"NCT06674109","phase":"PHASE4","title":"SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial","status":"NOT_YET_RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2026-04-30","conditions":"Gout and Hyperuricemia","enrollment":60},{"nctId":"NCT07157475","phase":"","title":"Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors","status":"RECRUITING","sponsor":"Wroclaw Medical University","startDate":"2025-07-01","conditions":"Peripheral Arterial Disease(PAD)","enrollment":300},{"nctId":"NCT07228195","phase":"PHASE4","title":"SGLT2i Therapy in Islet Transplantation (SIT)","status":"NOT_YET_RECRUITING","sponsor":"University of Minnesota","startDate":"2026-05-15","conditions":"Partial Islet Function, TPIAT, Diabetes","enrollment":40},{"nctId":"NCT07482020","phase":"PHASE2","title":"SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism","status":"RECRUITING","sponsor":"Huashan Hospital","startDate":"2025-03-01","conditions":"Atrial Fibrillation (AF), Hypertension","enrollment":66},{"nctId":"NCT03878706","phase":"","title":"The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination","status":"RECRUITING","sponsor":"University of Athens","startDate":"2017-11-03","conditions":"Diabetes Mellitus, Type 2","enrollment":240},{"nctId":"NCT07469943","phase":"","title":"The Effect of Sodium Glucose Co-trnasportert Type 2 Inhibitors on Arterial Stiffness, Endothelial Glycocalyx Thickness and Cardiac Deformation After Acute Myocardial Infarction","status":"RECRUITING","sponsor":"University of Athens","startDate":"2026-01-09","conditions":"Myocardial Infarction (MI), Diabete Type 2","enrollment":80},{"nctId":"NCT07053319","phase":"PHASE1","title":"SGLT2i, Pioglitazone, and Ketone Production in T2D","status":"RECRUITING","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2026-07-20","conditions":"Type 2 Diabetes","enrollment":64},{"nctId":"NCT06430684","phase":"EARLY_PHASE1","title":"Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease","status":"RECRUITING","sponsor":"Ann & Robert H Lurie Children's Hospital of Chicago","startDate":"2024-08-23","conditions":"Chronic Kidney Diseases, Pediatric Kidney Disease","enrollment":40},{"nctId":"NCT07044700","phase":"","title":"Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection Fraction","status":"NOT_YET_RECRUITING","sponsor":"Boehringer Ingelheim","startDate":"2028-01-31","conditions":"Heart Failure of Reduced Ejection Fraction (HFrEF)","enrollment":5000},{"nctId":"NCT06625073","phase":"PHASE4","title":"Randomized Trial of SGLT2i in Heart Transplant Recipients","status":"RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2026-01-20","conditions":"Heart Transplant, Cardiovascular Disease, Kidney Disease","enrollment":200},{"nctId":"NCT07348484","phase":"","title":"Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors","status":"NOT_YET_RECRUITING","sponsor":"Instituto de Investigación Biomédica de Salamanca","startDate":"2026-01","conditions":"Chronic Kidney Disease","enrollment":300},{"nctId":"NCT07055282","phase":"EARLY_PHASE1","title":"SGLT2i in Kidney Stones","status":"RECRUITING","sponsor":"University of Chicago","startDate":"2025-11-20","conditions":"Kidney Stones","enrollment":32},{"nctId":"NCT07331220","phase":"NA","title":"Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction","status":"NOT_YET_RECRUITING","sponsor":"Nanjing First Hospital, Nanjing Medical University","startDate":"2025-12-30","conditions":"Heart Failure With Preserved Ejection Fraction","enrollment":310},{"nctId":"NCT07325435","phase":"PHASE4","title":"Beta Cell Function in Type 2 Diabetes: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists","status":"ACTIVE_NOT_RECRUITING","sponsor":"MaryAnn Banerji","startDate":"2024-12-21","conditions":"Type 2 Diabetes (T2DM)","enrollment":60},{"nctId":"NCT06528405","phase":"PHASE2","title":"The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease","status":"RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2024-11-21","conditions":"Acute Kidney Injury","enrollment":264},{"nctId":"NCT07309094","phase":"","title":"Clinical, Morphometric and Biochemical Effects on Adiposopathy Associated With the Use of GLP-1RA in CKD","status":"RECRUITING","sponsor":"Cardenal Herrera University","startDate":"2023-09-15","conditions":"Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 1","enrollment":250},{"nctId":"NCT06609356","phase":"EARLY_PHASE1","title":"Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes","status":"RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2025-07-03","conditions":"Type 1 Diabetes Mellitus, Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY), MODY2 Diabetes","enrollment":27},{"nctId":"NCT07292909","phase":"PHASE4","title":"Effect of Empagliflozin on Inflammation","status":"RECRUITING","sponsor":"Hotel Dieu de France Hospital","startDate":"2025-09-01","conditions":"CAD - Coronary Artery Disease, Inflamation, PCI","enrollment":100},{"nctId":"NCT05220917","phase":"","title":"Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2021-08-01","conditions":"Cardiovascular Events, Type2 Diabetes, Renal Disease","enrollment":781430},{"nctId":"NCT05786443","phase":"PHASE2","title":"Safety and Efficacy of Empagliflozin in Hemodialysis","status":"RECRUITING","sponsor":"NYU Langone Health","startDate":"2024-01-31","conditions":"End Stage Renal Disease","enrollment":60},{"nctId":"NCT06410352","phase":"PHASE4","title":"Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome","status":"RECRUITING","sponsor":"University Medical Center, Kazakhstan","startDate":"2024-03-01","conditions":"Metabolic Syndrome","enrollment":220},{"nctId":"NCT05073692","phase":"","title":"Comparison of Type 2 Diabetes Pharmacotherapy Regimens","status":"COMPLETED","sponsor":"Kaiser Permanente","startDate":"2021-07-01","conditions":"Type 2 Diabetes Mellitus, Cardiovascular Diseases","enrollment":241981},{"nctId":"NCT06171802","phase":"PHASE4","title":"EMPagliflozin After Aortic Valve Replacement","status":"ACTIVE_NOT_RECRUITING","sponsor":"Rigshospitalet, Denmark","startDate":"2024-02-14","conditions":"Aortic Valve Stenosis","enrollment":205},{"nctId":"NCT05989503","phase":"PHASE4","title":"Initiation of ARNi and SGLT2i in Patients With HFrEF","status":"COMPLETED","sponsor":"Universidade do Porto","startDate":"2023-08-04","conditions":"Heart Failure With Reduced Ejection Fraction","enrollment":62},{"nctId":"NCT06697353","phase":"","title":"An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan","status":"COMPLETED","sponsor":"Bayer","startDate":"2024-11-01","conditions":"Chronic Heart Failure, Chronic Heart Failure With Reduced Ejection Fraction","enrollment":4936},{"nctId":"NCT06260059","phase":"PHASE4","title":"Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease","status":"RECRUITING","sponsor":"Anita Saraf","startDate":"2024-09-17","conditions":"Adult Congenital Heart Disease, Heart Failure","enrollment":40},{"nctId":"NCT07188545","phase":"","title":"Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ohio State University","startDate":"2025-09-15","conditions":"Cardiovascular Kidney Metabolic Syndrome","enrollment":23280000},{"nctId":"NCT07146880","phase":"PHASE2","title":"Empagliflozin as a Potential Therapeutic Solution for Patients With Brugada Syndrome","status":"NOT_YET_RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2025-09-15","conditions":"Brugada Syndrome (BrS)","enrollment":10},{"nctId":"NCT05278962","phase":"PHASE4","title":"HF Patients With LVADs Being Treated With SGLT2i","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2022-09-08","conditions":"Heart Failure With Reduced Ejection Fraction","enrollment":32},{"nctId":"NCT05350202","phase":"","title":"Emp-Activity: Empagliflozin Functional Capacity","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2022-12-18","conditions":"Heart Failure","enrollment":3431},{"nctId":"NCT07105917","phase":"PHASE3","title":"SLGT2i for Neuroprotection in Patients With Acute Ischemic Stroke","status":"NOT_YET_RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2025-08-01","conditions":"Acute Ischemic Stroke","enrollment":1050},{"nctId":"NCT06030843","phase":"PHASE2, PHASE3","title":"The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1","status":"RECRUITING","sponsor":"Chulalongkorn University","startDate":"2025-03-01","conditions":"Empagliflozin in Cardiorenal Syndrome Type 1","enrollment":200},{"nctId":"NCT06933355","phase":"PHASE4","title":"Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension","status":"ACTIVE_NOT_RECRUITING","sponsor":"Odense University Hospital","startDate":"2025-03-27","conditions":"Kidney Transplantation Recipients, Magnetic Resonance Imaging (MRI), Sodium-Glucose Transporter 2 Inhibitors","enrollment":8},{"nctId":"NCT04735042","phase":"","title":"SGLT-2 and DPP-4 Inhibition, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.","status":"COMPLETED","sponsor":"University of Pisa","startDate":"2020-10-07","conditions":"Type 2 Diabetes, Urinary Tract Infections","enrollment":60},{"nctId":"NCT07053293","phase":"EARLY_PHASE1","title":"SGLT2i, Hepatic Glucose Production, and SNS","status":"RECRUITING","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2025-01-07","conditions":"Type 2 Diabetes","enrollment":22},{"nctId":"NCT07053306","phase":"PHASE1","title":"SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia","status":"RECRUITING","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2025-04-29","conditions":"Type 2 Diabetes","enrollment":29},{"nctId":"NCT07060417","phase":"PHASE2","title":"Vascular Effects of SGLT2i in Non-diabetic CKD","status":"NOT_YET_RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2026-04-01","conditions":"Non-diabetic Chronic Kidney Disease","enrollment":52},{"nctId":"NCT06143566","phase":"PHASE1, PHASE2","title":"Polypill for Prevention of Cardiomyopathy","status":"RECRUITING","sponsor":"University of Texas Southwestern Medical Center","startDate":"2024-03-11","conditions":"Type 2 Diabetes, High Blood Pressure","enrollment":200},{"nctId":"NCT06453577","phase":"","title":"Pharmacokinetics of Bisoprolol and SGLT2i in Acutely Decompensated Heart Failure","status":"ACTIVE_NOT_RECRUITING","sponsor":"Universität des Saarlandes","startDate":"2023-05-01","conditions":"Acute Decompensated Heart Failure","enrollment":12},{"nctId":"NCT06929169","phase":"PHASE2","title":"Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study","status":"RECRUITING","sponsor":"Maximo Agustin Schiavone","startDate":"2025-05","conditions":"Chronic Kidney Disease Requiring Hemodialysis","enrollment":80},{"nctId":"NCT05637853","phase":"PHASE4","title":"Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction","status":"ACTIVE_NOT_RECRUITING","sponsor":"Göteborg University","startDate":"2022-10-22","conditions":"Heart Failure With Reduced Ejection Fraction","enrollment":60},{"nctId":"NCT04662723","phase":"PHASE4","title":"Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.","status":"RECRUITING","sponsor":"Fondazione Schena","startDate":"2023-05-01","conditions":"Glomerulonephritis, Immunoglobulin A Nephropathy","enrollment":878},{"nctId":"NCT06024746","phase":"PHASE3","title":"A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)","status":"RECRUITING","sponsor":"Colorado Prevention Center","startDate":"2024-07-09","conditions":"Heart Failure","enrollment":1500},{"nctId":"NCT03646292","phase":"PHASE4","title":"Antidiabetic Drugs for Steatotic Liver Disease","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2018-12-06","conditions":"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Type 2 Diabetes, Digestive System Disease","enrollment":51},{"nctId":"NCT06655480","phase":"PHASE2","title":"Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF","status":"NOT_YET_RECRUITING","sponsor":"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation","startDate":"2025-03-18","conditions":"HFpEF, LVDD, Myocardial Fibrosis","enrollment":50},{"nctId":"NCT06825156","phase":"PHASE4","title":"Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors","status":"COMPLETED","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2022-03-03","conditions":"Acute Kidney Injury","enrollment":60},{"nctId":"NCT05344963","phase":"","title":"Deformation Imaging by Strain in Chronic Heart Failure Over Gliflozins: an Echocardiographic Register on Sodium-GLucose coTransporter-2 Inhibitors","status":"COMPLETED","sponsor":"Matteo Cameli","startDate":"2022-04-01","conditions":"Sodium-GLucose coTransporter-2 Inhibitors, Heart Failure With Reduced Ejection Fraction","enrollment":503},{"nctId":"NCT06065280","phase":"NA","title":"Sodium-glucose Transport 2 Inhibitors (SGLT2i) in HFrEF Patients","status":"COMPLETED","sponsor":"Damanhour University","startDate":"2022-11-01","conditions":"Heart Failure, Reduced Ejection Fraction Heart Failure","enrollment":80},{"nctId":"NCT06753994","phase":"PHASE1","title":"Continuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors","status":"RECRUITING","sponsor":"McGill University","startDate":"2024-12-05","conditions":"Diabetes, Type1diabetes, T1D","enrollment":24},{"nctId":"NCT05129722","phase":"PHASE4","title":"Polydiuretic Therapy for HFpEF, a Randomised Controlled Trial","status":"TERMINATED","sponsor":"The George Institute","startDate":"2022-10-01","conditions":"Heart Failure With Preserved Ejection Fraction","enrollment":3},{"nctId":"NCT03817463","phase":"","title":"A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2019-04-15","conditions":"Diabetes Mellitus, Type 2","enrollment":327624},{"nctId":"NCT05465317","phase":"","title":"Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2022-08-08","conditions":"Diabetes Mellitus, Type 2","enrollment":62197},{"nctId":"NCT06091475","phase":"NA","title":"Therapy to Maintain Remission in Dilated Cardiomyopathy","status":"RECRUITING","sponsor":"Imperial College London","startDate":"2023-12-02","conditions":"Heart Failure, Cardiomyopathy, Dilated, Cardiomyopathies","enrollment":50},{"nctId":"NCT06585761","phase":"","title":"Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2024-02-15","conditions":"Heart Failure","enrollment":60},{"nctId":"NCT04342819","phase":"PHASE2, PHASE3","title":"The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.","status":"COMPLETED","sponsor":"The University of The West Indies","startDate":"2020-01-01","conditions":"Platelet Dysfunction Due to Drugs","enrollment":25},{"nctId":"NCT06124924","phase":"EARLY_PHASE1","title":"SGLT2 Inhibitors After Acute Kidney Injury With Indications Pilot","status":"TERMINATED","sponsor":"University of Minnesota","startDate":"2024-04-01","conditions":"Acute Kidney Injury","enrollment":1},{"nctId":"NCT06021145","phase":"PHASE4","title":"Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes","status":"RECRUITING","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2024-04-02","conditions":"Type 1 Diabetes","enrollment":46},{"nctId":"NCT05233163","phase":"PHASE4","title":"SGLT2 Inhibitors in Transthyretin Amyloid Cardiomyopathy","status":"COMPLETED","sponsor":"Columbia University","startDate":"2022-03-14","conditions":"Transthyretin Amyloid Cardiomyopathy","enrollment":15},{"nctId":"NCT06469645","phase":"PHASE2, PHASE3","title":"The Role of SGLT2i in Management of Moderate AS","status":"RECRUITING","sponsor":"University of East Anglia","startDate":"2024-05-30","conditions":"Moderate Aortic Valve Stenosis","enrollment":104},{"nctId":"NCT04523064","phase":"PHASE4","title":"POST-CABGDM: Empagliflozin in Perioperative CABG","status":"COMPLETED","sponsor":"University of Sao Paulo General Hospital","startDate":"2020-09-22","conditions":"Diabetes Mellitus, Type 2, Coronary Artery Disease, Coronary Artery Bypass Surgery","enrollment":155},{"nctId":"NCT06147271","phase":"PHASE2","title":"Impact of SGLT2 Inhibitors in Heart Transplant Recipients","status":"ENROLLING_BY_INVITATION","sponsor":"Universidade Federal do Ceara","startDate":"2023-11-20","conditions":"Transplant; Failure, Heart, Cardiac Allograft Vasculopathy, Rejection Heart Transplant","enrollment":80},{"nctId":"NCT06401343","phase":"PHASE4","title":"Use of SGLT2i in noHCM With HFpEF","status":"RECRUITING","sponsor":"China National Center for Cardiovascular Diseases","startDate":"2022-08-01","conditions":"Hypertrophic Cardiomyopathy, Heart Failure With Preserved Ejection Fraction","enrollment":94},{"nctId":"NCT03918148","phase":"","title":"Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA)","status":"COMPLETED","sponsor":"University of Campania Luigi Vanvitelli","startDate":"2018-01-15","conditions":"Type 2 Diabetes Mellitus","enrollment":1150},{"nctId":"NCT06201000","phase":"","title":"Effect of Genetic Polymorphisms on the Clinical Response to SGLT2 Inhibitors in Heart Failure Patients","status":"UNKNOWN","sponsor":"October 6 University","startDate":"2023-12-27","conditions":"Genetic Polymorphisms, Heart Failure","enrollment":282},{"nctId":"NCT06187493","phase":"NA","title":"Treatment of Patients With Diabetic Kidney Disease","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2024-01-01","conditions":"Diabetic Kidney Disease","enrollment":70},{"nctId":"NCT06142474","phase":"PHASE3","title":"SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning","status":"RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2022-10-10","conditions":"Heart Failure Acute, Ventilator Lung","enrollment":450},{"nctId":"NCT06113900","phase":"PHASE1, PHASE2","title":"Assessment of Safety and Efficacy of SGLT2is Among LN Patients","status":"UNKNOWN","sponsor":"Ain Shams University","startDate":"2023-12-01","conditions":"Lupus Nephritis","enrollment":50},{"nctId":"NCT05605158","phase":"PHASE3","title":"Comparative Clinical Study Between Empagliflozin Versus Pioglitazone in Non-diabetic Patients With Non-alcoholic Steatohepatitis","status":"UNKNOWN","sponsor":"Tanta University","startDate":"2022-11","conditions":"Non Alcoholic Steatohepatitis","enrollment":56},{"nctId":"NCT03979352","phase":"PHASE3","title":"Effect of SGLT2i in Conjunction With the Artificial Pancreas on Improving the Glycemia in T1DM in the Outpatient Setting","status":"COMPLETED","sponsor":"Samuel Lunenfeld Research Institute, Mount Sinai Hospital","startDate":"2019-08-01","conditions":"Type1 Diabetes Mellitus","enrollment":28},{"nctId":"NCT04853615","phase":"","title":"SGLT2 Inhibitors Prophylaxis Against Post-contrast Acute Kidney Injury in Diabetic Kidney Disease?","status":"UNKNOWN","sponsor":"Fayoum University","startDate":"2021-07-01","conditions":"SGLT2i Kideny Protection Against Contrast in Diabetic Kidney","enrollment":800},{"nctId":"NCT02846233","phase":"NA","title":"Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2016-08","conditions":"Type 2 Diabetes Mellitus","enrollment":22},{"nctId":"NCT03917758","phase":"NA","title":"Antidiuretic Function Before and During Treatment With SGLT2 Inhibitors","status":"UNKNOWN","sponsor":"University of Turin, Italy","startDate":"2018-10-10","conditions":"Diabetes Mellitus, Type 2, Arterial Hypertension, Body Weight Changes","enrollment":30},{"nctId":"NCT04196231","phase":"PHASE4","title":"Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes (BEYOND)","status":"COMPLETED","sponsor":"University of Campania Luigi Vanvitelli","startDate":"2019-11-27","conditions":"Type 2 Diabetes","enrollment":258},{"nctId":"NCT04184947","phase":"","title":"Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists","status":"COMPLETED","sponsor":"University of Padova","startDate":"2014-03-01","conditions":"Type 2 Diabetes","enrollment":10000},{"nctId":"NCT03050229","phase":"PHASE4","title":"SGLT-2i and ARB Combination Therapy in Patients With T2DM and Nocturnal Hypertension (SACRA Study)","status":"COMPLETED","sponsor":"Jichi Medical University","startDate":"2017-01","conditions":"Nocturnal Hypertension, T2DM (Type 2 Diabetes Mellitus)","enrollment":174},{"nctId":"NCT03249506","phase":"","title":"Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2016-05-12","conditions":"Diabetes Mellitus, Type 2","enrollment":25358},{"nctId":"NCT02857764","phase":"","title":"Sodium-glucose Co-transporter 2 (SGLT2) Inhibitor Risk of Below-Knee Lower Extremity Amputation: A Retrospective Cohort Study Using a Large Claims Database in the United States","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2016-02-15","conditions":"Diabetes Mellitus, Type 2","enrollment":127690}],"_emaApprovals":[{"date":"","name":"Empagliflozin (SGLT2i)","status":"Authorised","regulator":"EMA"}],"_faersSignals":[],"manufacturing":[{"role":"Manufacturer","site":"Boehringer Ingelheim Pharmaceuticals, Inc.","location":"","operator":"Boehringer Ingelheim Pharmaceuticals, Inc."}],"molecularData":{"oral":true,"chemblId":"CHEMBL2107830","moleculeType":"Small molecule","molecularWeight":"450.92"},"_patentsChecked":true,"_approvalHistory":[],"_offLabelChecked":true,"ownershipHistory":[{"period":"2015-present","_source":"FDA label","companyName":"BOEHRINGER INGELHEIM","relationship":"Originator"}],"pharmacokinetics":{"source":"FDA label","clearance":"10.6 L/h"},"publicationCount":1,"atcClassification":{"source":"FDA openfda","atcCode":"","mechClass":"Sodium-Glucose Transporter 2 Inhibitors [MoA]","pharmClass":"Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"},"recentPublications":[{"date":"2025 Nov","pmid":"40619592","title":"Utilization of Proteomic Measures for Early Detection of Drug Benefits and Adverse Effects.","journal":"Journal of clinical pharmacology"}],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"_genericFilersChecked":true,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"companionDiagnostics":[],"patents":[],"trials":[],"biosimilars":[],"latestUpdates":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","companyName":"Hotel Dieu de France Hospital","companyId":"hotel-dieu-de-france-hospital","modality":"Small molecule","firstApprovalDate":"2015","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}