Primary completion· ClinicalTrials.gov
Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients
Empagliflozin History and Updates
250 events · 2002 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
504
FDA Approvals
93
Label Revisions
2,323
Trial Milestones
10
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-26Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Empagliflozin since 2002, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (27)
2026
- Results postedJardiance Post-Marketing Study in Korean CKD Patients Details Safety & UACR…· Jun 23, 2026
- Label revisionJardiance Label Adds Indications for Heart Failure and Kidney Disease· Jun 17, 2026
- Primary completionEmpagliflozin Trial for Acute Decompensated Heart Failure Reaches Primary…· Apr 30, 2026
- Primary completionEmpagliflozin: Phase 3 T2DM Trial with Metformin Reaches Primary Completion· Apr 16, 2026
- Label revisionSynjardy Label Receives Boxed Warning for Lactic Acidosis· Jan 30, 2026
2025
- Primary completionEmpagliflozin Phase 3 Trial for Metabolic Syndrome Reaches Primary Completion· Dec 31, 2025
- Results postedEmpagliflozin: MACE Incidence Data Posted for Diabetes Regimen Comparison· Nov 21, 2025
- FDA approvalLinagliptin And Metformin Hydrochloride Generic Receives FDA Approval· Nov 3, 2025
- Results postedEmpagliflozin Pilot for Cognitive Impairment: Safety Profile Holds· Oct 21, 2025
- Results postedEmpagliflozin/Linagliptin Reduces HbA1c in Korean Type 2 Diabetes· Aug 27, 2025
- Results postedEmpagliflozin Trial Shows Improved Functional Capacity in Heart Failure Patients· Aug 26, 2025
- Results postedJardiance Post-Marketing Surveillance in CHF Reports Safety and Event Rates· Aug 6, 2025
- Primary completionEmpagliflozin Trial for Type 2 Diabetes and Dyslipidemia Completes Phase 3· Apr 30, 2025
- Results postedEmpagliflozin Combination Trial for Portal Hypertension Terminated· Apr 29, 2025
- Results postedEmpagliflozin Shows Lower Urinary Tract Malignancy Risk in Type 2 Diabetes· Mar 28, 2025
- FDA approval (supplemental)Synjardy (Empagliflozin/Metformin) Receives FDA Supplemental Efficacy Approval· Mar 7, 2025
- FDA approval (supplemental)Synjardy XR (empagliflozin, metformin) receives FDA supplemental efficacy…· Mar 7, 2025
- Pivotal publicationEmpagliflozin Long-Term Effects in Chronic Kidney Disease Published· Jan 1, 2025
2024
- Pivotal publicationEmpagliflozin Publication Details Acute Myocardial Infarction Outcomes· Jan 1, 2024
2023
- Pivotal publicationEmpagliflozin Study Results Published for Chronic Kidney Disease Patients· Jan 1, 2023
- Pivotal publicationEmpagliflozin: Pivotal Publication on Higher Dose Corticosteroids in COVID-19· Jan 1, 2023
2022
- Pivotal publicationAspirin: RECOVERY Trial Publishes COVID-19 Hospitalization Data· Jan 1, 2022
- Pivotal publicationCasirivimab and imdevimab: RECOVERY Trial Publishes COVID-19 Hospitalization…· Jan 1, 2022
- Pivotal publicationBaricitinib: RECOVERY Trial Results Published for COVID-19 Patients· Jan 1, 2022
- Pivotal publicationEmpagliflozin: Comparative Study vs Pioglitazone for Non-diabetic NASH Published· Jan 1, 2022
- Pivotal publicationEmpagliflozin: RECOVERY Trial Publishes Convalescent Plasma Results for COVID-19· Jan 1, 2022
- Pivotal publicationTocilizumab RECOVERY Trial for Hospitalized COVID-19 Patients Published in…· Jan 1, 2022
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients W
Primary completion· ClinicalTrials.gov
Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
Trial started· ClinicalTrials.gov
Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
Primary completion· ClinicalTrials.gov
Comparative Effectiveness of Empagliflozin in the US
Primary completion· ClinicalTrials.gov
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
Primary completion· ClinicalTrials.gov
Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity
Primary completion· ClinicalTrials.gov
SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
Primary completion· ClinicalTrials.gov
Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations
Trial started· ClinicalTrials.gov
SGLT2i Therapy in Islet Transplantation (SIT)
Trial started· ClinicalTrials.gov
SGLT2i, Pioglitazone, and Ketone Production in T2D
Primary completion· ClinicalTrials.gov
EMPA-ESUS. a Randomised Control Trial to Investigate the Impact of Empagliflozin on Left Atrial Function in Patients with Embolic Stroke of
Primary completion· ClinicalTrials.gov
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATI
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
Primary completion· ClinicalTrials.gov
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
Trial started· ClinicalTrials.gov
A Study of Metformin to Improve Cardiac Function After LVAD Implantation
Trial started· ClinicalTrials.gov
Vascular Effects of SGLT2i in Non-diabetic CKD
Primary completion· ClinicalTrials.gov
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
Primary completion· ClinicalTrials.gov
Danish Precocious Puberty Study - DAPP Study A National Cohort Study on Incidence and Etiologies for Precocious Puberty
Primary completion· ClinicalTrials.gov
Feasibility Trial for a Right Ventricular Failure Platform Trial
Primary completion· ClinicalTrials.gov
Treating the Metabolic Syndrome With a Sodium-glucose Cotransporter-2 Inhibitor
Primary completion· ClinicalTrials.gov
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Effect of SGLT2 Inhibitors on NAFLD in Type 2 Diabetic Patients with Diabetic Nephropathy
Primary completion· ClinicalTrials.gov
Empagliflozin in Hypertrophic Cardiomyopathy
Primary completion· ClinicalTrials.gov
Metformin IN Asthma for Overweight and Obese Individuals (MINA)
Primary completion· ClinicalTrials.gov
Pilot Study on Evaluating the Geroprotective Effect of Metformin
Primary completion· ClinicalTrials.gov
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Primary completion· ClinicalTrials.gov
Empagliflozin Adjunctive Therapy in Bipolar Depression
Primary completion· ClinicalTrials.gov
Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.
Primary completion· ClinicalTrials.gov
Ketones, SGLT2, HFrEF
Primary completion· ClinicalTrials.gov
Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD
Primary completion· ClinicalTrials.gov
SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
Primary completion· ClinicalTrials.gov
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Primary completion· ClinicalTrials.gov
Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy
Primary completion· ClinicalTrials.gov
Safety and Efficacy of Empagliflozin in Hemodialysis
Primary completion· ClinicalTrials.gov
Metformin Hydrochloride Sustained-release Tablets (Ⅲ) in Patients With Type 2 Diabetes Mellitus Complicated With Coronary Heart Disease
Primary completion· ClinicalTrials.gov
Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Effects of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension
Primary completion· ClinicalTrials.gov
Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer
Primary completion· ClinicalTrials.gov
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
Primary completion· ClinicalTrials.gov
A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus a
Primary completion· ClinicalTrials.gov
Reducing Non-Alcoholic Steatohepatitis
Primary completion· ClinicalTrials.gov
A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension
Primary completion· ClinicalTrials.gov
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Primary completion· ClinicalTrials.gov
Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure
Primary completion· ClinicalTrials.gov
Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin
Primary completion· ClinicalTrials.gov
Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Section Scar Defect
Primary completion· ClinicalTrials.gov
Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia
Past events
2026
Trial registered· ClinicalTrials.gov
A Study of Metformin to Improve Cardiac Function After LVAD Implantation
Results posted· ClinicalTrials.gov
JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD)
Label revision· FDA
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, acco
Label revision· FDA
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, accom
Label revision· FDA
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, accom
Primary completion· ClinicalTrials.gov
Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data
Label revision· FDA
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, acco
Label revision· FDA
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, accom
Label revision· FDA
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, accomp
Label revision· FDA
BOXED WARNING 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
Label revision· FDA
BOXED WARNING 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
Label revision· FDA
1 INDICATIONS AND USAGE JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardio
Label revision· FDA
BOXED WARNING 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
Label revision· FDA
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, accom
Label revision· FDA
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, accomp
Primary completion· ClinicalTrials.gov
Emulation of the EMPEROR-Reduced Trial Using Healthcare Claims Data
Primary completion· ClinicalTrials.gov
Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
INDICATIONS AND USAGE Glipizide and metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accom
Label revision· FDA
WARNING: LACTIC ACIDOSIS Post-marketing 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, accom
Label revision· FDA
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
Label revision· FDA
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, accom
Label revision· FDA
BOXED WARNING 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
Label revision· FDA
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
Label revision· FDA
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, accomp
Label revision· FDA
BOXED WARNING 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
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Primary completion· ClinicalTrials.gov
Empagliflozin in Patients With Cirrhosis and Ascites
Primary completion· ClinicalTrials.gov
Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data
Primary completion· ClinicalTrials.gov
Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Primary completion· ClinicalTrials.gov
Emulation of the EMPEROR-Reduced Trial Using Healthcare Claims Data
Primary completion· ClinicalTrials.gov
Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II
Primary completion· ClinicalTrials.gov
Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus
Primary completion· ClinicalTrials.gov
EMPagliflozin After Aortic Valve Replacement
Trial started· ClinicalTrials.gov
PRECISE Phenotyping to Guide Therapies for Coronary Microvascular Dysfunction
Primary completion· ClinicalTrials.gov
Use of Empagliflozin to Treat Prediabetes
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
Primary completion· ClinicalTrials.gov
Comparative Effectiveness of Empagliflozin in the US
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin
Label revision· FDA
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, accomp
Trial registered· ClinicalTrials.gov
Krill Oil and Metformin in Women With PCOS and Metabolically Unhealthy Obesity
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
BOXED WARNING 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
Label revision· FDA
Boxed warning present on label on glyburide and metformin hydrochloride label (effective 2026-05-21)
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
Label revision· FDA
Boxed warning present on label on glyburide and metformin hydrochloride label (effective 2026-05-21)
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
FDA approval (supplemental)· FDA
Sponsor: SUN PHARM. Class: Manufacturing (CMC).
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Trial registered· ClinicalTrials.gov
Emulation of the EMPEROR-Reduced Trial Using Healthcare Claims Data
Trial registered· ClinicalTrials.gov
Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Trial started· ClinicalTrials.gov
SGLT2i Therapy in Islet Transplantation (SIT)
Trial registered· ClinicalTrials.gov
SGLT2 Adjunct in T1D
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Results posted· ClinicalTrials.gov
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Sma
Label revision· FDA
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, accom
Primary completion· ClinicalTrials.gov
EMPagliflozin After Aortic Valve Replacement
Label revision· FDA
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, accomp
Label revision· FDA
Boxed warning present on label on Glyburide and Metformin Hydrochloride label (effective 2026-05-07)
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
Label revision· FDA
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, accomp
Label revision· FDA
Boxed warning present on label on Glyburide and Metformin Hydrochloride label (effective 2026-05-07)
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
Label revision· FDA
BOXED WARNING 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
Label revision· FDA
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, accom
Primary completion· ClinicalTrials.gov
Empagliflozin in ESKD - A Feasibility Study
Primary completion· ClinicalTrials.gov
Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes
Primary completion· ClinicalTrials.gov
Glycemic Control With Triple Pathway Approach Through Empagliflozin, Linagliptin and Metformin Combination
Primary completion· ClinicalTrials.gov
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute D
Primary completion· ClinicalTrials.gov
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
Trial started· ClinicalTrials.gov
Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2
Trial started· ClinicalTrials.gov
SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial
Trial registered· ClinicalTrials.gov
Empagliflozin and CPAP in Adults With Heart Failure and Obstructive Sleep Apnea.
Trial registered· ClinicalTrials.gov
Simultaneous Starting of the 4 Guideline Directed CKD Therapies (RAPID-CKD)
Results posted· ClinicalTrials.gov
Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer
Trial registered· ClinicalTrials.gov
Empagliflozin Versus Non-SGLT2 Oral Drugs for Blood Pressure in Type 2 Diabetes
Trial registered· ClinicalTrials.gov
PRECISE Phenotyping to Guide Therapies for Coronary Microvascular Dysfunction
Label revision· FDA
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, accomp
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin
Trial registered· ClinicalTrials.gov
Effects of Empagliflozin-Metformin, Sitagliptin-Metformin, and Metformin on Adipokines in Type 2 Diabetes
Trial started· ClinicalTrials.gov
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
Trial started· ClinicalTrials.gov
Simultaneous Starting of the 4 Guideline Directed CKD Therapies (RAPID-CKD)
FDA approval· FDA
Sponsor: ALKEM LABS LTD.
FDA approval· FDA
Sponsor: LUPIN.
FDA approval· FDA
Sponsor: SUN PHARM.
FDA approval· FDA
Sponsor: AUROBINDO PHARMA.
FDA approval· FDA
Sponsor: MSN.
FDA approval· FDA
Sponsor: MACLEODS PHARMS LTD.
Primary completion· ClinicalTrials.gov
Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension
Trial started· ClinicalTrials.gov
Vascular Effects of SGLT2i in Non-diabetic CKD
Trial started· ClinicalTrials.gov
Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients
Primary completion· ClinicalTrials.gov
Metformin, Empagliflozin With Sitagliptin vs Linagliptin in Type 2 Diabetes
Results posted· ClinicalTrials.gov
Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Trial registered· ClinicalTrials.gov
Bioequivalence Study of EMPAGLIFLOZIN (25 mg Tablets) vs. JARDIANCE® (25 mg Tablets), in Healthy Research Subjects, Under Fasting Conditions
Label revision· FDA
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, accom
Primary completion· ClinicalTrials.gov
Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease
Trial registered· ClinicalTrials.gov
Empagliflozin Adjunctive Therapy in Bipolar Depression
Primary completion· ClinicalTrials.gov
Empagliflozin for No-reflow Phenomenon in PCI for STEMI
Primary completion· ClinicalTrials.gov
A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body
Primary completion· ClinicalTrials.gov
Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity
Trial started· ClinicalTrials.gov
Empagliflozin Adjunctive Therapy in Bipolar Depression
Trial registered· ClinicalTrials.gov
Metformin, Empagliflozin With Sitagliptin vs Linagliptin in Type 2 Diabetes
Trial started· ClinicalTrials.gov
Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic So
Trial registered· ClinicalTrials.gov
Glycemic Variability of Combination Therapies in T2DM
Primary completion· ClinicalTrials.gov
The Role of SGLT2i in Management of Moderate AS
Trial started· ClinicalTrials.gov
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
Primary completion· ClinicalTrials.gov
ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling
Primary completion· ClinicalTrials.gov
HER2HEART-US: Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy
Primary completion· ClinicalTrials.gov
Empagliflozin in Acute Heart Failure
Primary completion· ClinicalTrials.gov
Clinical Efficacy of 1% Metformin and Alendronate Gel in Adjunct to Fibrin in Chronic Periodontitis
Label revision· FDA
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, accomp
Primary completion· ClinicalTrials.gov
Antithrombotic Activities of Sotagliflozin vs. Empagliflozin
Trial started· ClinicalTrials.gov
A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body
Trial started· ClinicalTrials.gov
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Mida
Trial registered· ClinicalTrials.gov
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
Primary completion· ClinicalTrials.gov
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
Trial registered· ClinicalTrials.gov
Metformin vs Inositol vs Diet vs Combination Therapy in PCOS
Trial started· ClinicalTrials.gov
Add-on Diuretics in Acute Decompensated Heart Failure
Primary completion· ClinicalTrials.gov
Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease
Trial started· ClinicalTrials.gov
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Label revision· FDA
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, accomp
Trial registered· ClinicalTrials.gov
ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling
Label revision· FDA
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, accomp
Primary completion· ClinicalTrials.gov
Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors
Label revision· FDA
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, accomp
Results posted· ClinicalTrials.gov
Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma
Trial registered· ClinicalTrials.gov
Add-on Diuretics in Acute Decompensated Heart Failure
Label revision· FDA
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, accomp
Trial registered· ClinicalTrials.gov
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in F
Trial registered· ClinicalTrials.gov
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Mida
Trial registered· ClinicalTrials.gov
A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body
Trial registered· ClinicalTrials.gov
Effect Of Sodium Glucose Co-Transporter-2 (SGLT-2) Inhibitors on Body Mass Index After 3 Months of Use in Diabetic Patients
Trial registered· ClinicalTrials.gov
Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients
Primary completion· ClinicalTrials.gov
CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients
Trial started· ClinicalTrials.gov
Randomized Trial of SGLT2i in Heart Transplant Recipients
Trial registered· ClinicalTrials.gov
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Label revision· FDA
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, accomp
Trial registered· ClinicalTrials.gov
Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy
Primary completion· ClinicalTrials.gov
A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
Results posted· ClinicalTrials.gov
A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furo
Trial registered· ClinicalTrials.gov
A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
Trial registered· ClinicalTrials.gov
DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis
Label revision· FDA
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, accomp
Trial started· ClinicalTrials.gov
DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis
Label revision· FDA
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, accomp
Trial started· ClinicalTrials.gov
Metformin, Empagliflozin With Sitagliptin vs Linagliptin in Type 2 Diabetes
2025
Primary completion· ClinicalTrials.gov
DANHEART (H-HeFT and Met-HeFT)
Trial registered· ClinicalTrials.gov
A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus a
Primary completion· ClinicalTrials.gov
Metformin Hydrochloride and Empagliflozin Tablets in the Treatment of Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
Primary completion· ClinicalTrials.gov
LIGHT-MCI Trial: GLP-1 Agonist, SGLT2 Inhibitor, and DPP-4 Inhibitor for MCI Remission in Type 2 Diabetes
Trial started· ClinicalTrials.gov
Targeting the Pathophysiology of Sickle Cell-Related Kidney Disease Using the SGLT2 Inhibitors, Empagliflozin
Primary completion· ClinicalTrials.gov
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Primary completion· ClinicalTrials.gov
Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis
Primary completion· ClinicalTrials.gov
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in F
Trial registered· ClinicalTrials.gov
Improving Cardiovascular Disease Diagnosis and Treatment in Kazakhstan Using Metabolic Correction With GLP-1 Drugs
Label revision· FDA
INDICATIONS & USAGE Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
Trial registered· ClinicalTrials.gov
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
Trial started· ClinicalTrials.gov
ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling
Trial started· ClinicalTrials.gov
A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus a
Primary completion· ClinicalTrials.gov
Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease
Trial registered· ClinicalTrials.gov
Effect of Empagliflozin on Inflammation
Trial registered· ClinicalTrials.gov
Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic So
Label revision· FDA
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, accom
Results posted· ClinicalTrials.gov
Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers
Primary completion· ClinicalTrials.gov
Metformin and Nightly Fasting in Women With Early Breast Cancer
Trial started· ClinicalTrials.gov
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
Trial started· ClinicalTrials.gov
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute D
Label revision· FDA
INDICATIONS & USAGE Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
Trial registered· ClinicalTrials.gov
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg
FDA approval· FDA
Sponsor: SANDOZ.
Primary completion· ClinicalTrials.gov
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome
Label revision· FDA
WARNING: LACTIC ACIDOSIS WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradya
Primary completion· ClinicalTrials.gov
Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis
Primary completion· ClinicalTrials.gov
Effects of Acute and Chronic Empagliflozin Heart Failure
Primary completion· ClinicalTrials.gov
Metabolic Responses of Metformin and Genetic Polymorphisms of SLC22A1 Gene in PCOS
Primary completion· ClinicalTrials.gov
Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels
Primary completion· ClinicalTrials.gov
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1
Primary completion· ClinicalTrials.gov
Effects of Empagliflozin-Metformin, Sitagliptin-Metformin, and Metformin on Adipokines in Type 2 Diabetes
Trial registered· ClinicalTrials.gov
The Efficacy and Safety of Empagliflozin - Linagliptin and Empagliflozin- Metformin Therapy in Reduction of Body Weight in Type 2 Diabetic P
Results posted· ClinicalTrials.gov
Comparison of Type 2 Diabetes Pharmacotherapy Regimens
Trial started· ClinicalTrials.gov
SGLT2i in Kidney Stones
Primary completion· ClinicalTrials.gov
SGLT2 Adjunct in T1D
Trial started· ClinicalTrials.gov
SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
Trial registered· ClinicalTrials.gov
SGLT2i Therapy in Islet Transplantation (SIT)
Primary completion· ClinicalTrials.gov
Metformin vs Inositol vs Diet vs Combination Therapy in PCOS
FDA approval (supplemental)· FDA
Sponsor: GRANULES INDIA. Class: Manufacturing (CMC).
Primary completion· ClinicalTrials.gov
Empagliflozin Versus Non-SGLT2 Oral Drugs for Blood Pressure in Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
FDA approval· FDA
Sponsor: MSN.
Trial started· ClinicalTrials.gov
Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease
Primary completion· ClinicalTrials.gov
Empagliflozin in ESKD - A Feasibility Study
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.