Primary completion· ClinicalTrials.gov
Effect of SGLT2 Inhibitors on NAFLD in Type 2 Diabetic Patients with Diabetic Nephropathy
Empagliflozin History and Updates
250 events · 2002 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
505
FDA Approvals
162
Label Revisions
2,387
Trial Milestones
10
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-09-24Download 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 (35)
2026
- Results postedEmpagliflozin posts electrolyte results in kidney disease trial· Sep 22, 2026
- Results postedEmpagliflozin shows higher time in range in cystic fibrosis diabetes trial· Sep 21, 2026
- Results postedEmpagliflozin Trial Shows HbA1c Improvement With Lanifibranor· Sep 9, 2026
- Label revisionJardiance Label Updates Heart Failure and Kidney Indications· Aug 26, 2026
- Label revisionSynjardy Label Boxed Warning Revised for Lactic Acidosis· Aug 25, 2026
- Label revisionEmpagliflozin: Trijardy XR Label Carries Boxed Warning· Aug 24, 2026
- Results postedEmpagliflozin PMS in Korean heart failure patients posted· Aug 10, 2026
- Results postedEmpagliflozin Combination Shows Superior UACR Reduction in CKD, T2D· Jul 13, 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
Empagliflozin in Hypertrophic Cardiomyopathy
Trial started· ClinicalTrials.gov
The GranStone Trial
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
Trial started· ClinicalTrials.gov
Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2
Trial started· ClinicalTrials.gov
Neurovascular Effects of Empagliflozin
Trial started· ClinicalTrials.gov
Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease
Trial started· ClinicalTrials.gov
Vascular Effects of SGLT2i in Non-diabetic CKD
Trial started· ClinicalTrials.gov
Role of Finerenone in African American Veterans With Diabetic Kidney Disease
Trial started· ClinicalTrials.gov
Cardioprotective Effect of Empagliflozin in Breast Cancer Patients
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
Trial started· ClinicalTrials.gov
Study on Improving Blood Glucose Homeostasis With Dorzagliatin Tablets in the Treatment of Type 2 Diabetes Mellitus Patients With Moderate t
Primary completion· ClinicalTrials.gov
the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients
Primary completion· ClinicalTrials.gov
Empagliflozin in Patients With Cirrhosis and Ascites
Primary completion· ClinicalTrials.gov
The Efficacy of Empagliflozin on Kidney Functions in Lupus Nephritis Population
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
Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity
Primary completion· ClinicalTrials.gov
EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
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
Primary completion· ClinicalTrials.gov
A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adul
Primary completion· ClinicalTrials.gov
Glycemic Regulation as Endometriosis Adjunct Treatment
Primary completion· ClinicalTrials.gov
Add-on Diuretics in Acute Decompensated Heart Failure
Primary completion· ClinicalTrials.gov
Metformin Add-on Clinical Study in Multiple Sclerosis to Evaluate Brain Remyelination And Neurodegeneration
Primary completion· ClinicalTrials.gov
Efficacy of SGLT2 Inhibitors in Adults With Sepsis
Primary completion· ClinicalTrials.gov
Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejectio
Primary completion· ClinicalTrials.gov
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Mida
Primary completion· ClinicalTrials.gov
Glycemic Variability of Combination Therapies in T2DM
Primary completion· ClinicalTrials.gov
Repurposing Empagliflozin for DMD-associated Cardiomyopathy in Children 6-18 Years of Age
Primary completion· ClinicalTrials.gov
Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease
Past events
2026
Results posted· ClinicalTrials.gov
Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
Results posted· ClinicalTrials.gov
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes
Trial registered· ClinicalTrials.gov
The GranStone Trial
Primary completion· ClinicalTrials.gov
Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia
Primary completion· ClinicalTrials.gov
Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia
Results posted· ClinicalTrials.gov
Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors
Trial registered· ClinicalTrials.gov
Cardioprotective Effect of Empagliflozin in Breast Cancer Patients
Results posted· ClinicalTrials.gov
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor
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 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
Neurovascular Effects of Empagliflozin
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 for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
Trial started· ClinicalTrials.gov
QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy
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
Timing of Empagliflozin in Primary PCI: Pre-Reperfusion Versus Post-Reperfusion Versus Placebo in South Asian STEMI Patients
Label revision· FDA
WARNING: CONGESTIVE HEART FAILURE and LACTIC ACIDOSIS See full prescribing information for complete boxed warning. Congestive Heart Failure • Thiazolidinediones, including pioglitazone, which is a component of pioglitazone and metformin hyd
Primary completion· ClinicalTrials.gov
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Trial started· ClinicalTrials.gov
Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease
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
Danish Precocious Puberty Study - DAPP Study A National Cohort Study on Incidence and Etiologies for Precocious Puberty
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
FDA approval (supplemental)· FDA
Sponsor: ANNORA PHARMA. Class: Labeling.
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
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
Trial registered· ClinicalTrials.gov
Study on Improving Blood Glucose Homeostasis With Dorzagliatin Tablets in the Treatment of Type 2 Diabetes Mellitus Patients With Moderate t
Trial registered· ClinicalTrials.gov
Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity
Label revision· FDA
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmia's. 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
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 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 metformin-associated lactic acidosis is often subtle, accomp
Label revision· FDA
WARNING: CONGESTIVE HEART FAILURE and LACTIC ACIDOSIS Congestive Heart Failure Thiazolidinediones, including pioglitazone, which is a component of ACTOPLUS MET ® , cause or exacerbate congestive heart failure in some patients [see Warnings
Trial registered· ClinicalTrials.gov
Clinical Impact of SGLT2 Inhibitor After DC Cardioversion in Persistent AF With HFpEF
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
QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy
Primary completion· ClinicalTrials.gov
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
Label revision· FDA
Boxed warning present on label on Glyburide and Metformin Hydrochloride label (effective 2026-08-18)
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
The Effect of Empagliflozin and Metformin on Oxidative Capacity and Microvascular Reactivity of Skeletal Muscle in Patients With Type 2 Diab
Label revision· FDA
Label revision· FDA
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmia's. The onset of metformin-associated lactic acidosis is often subtle, accom
Primary completion· ClinicalTrials.gov
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
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 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 brad
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 brad
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 brad
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, 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, 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
Trial registered· ClinicalTrials.gov
Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease
Results posted· ClinicalTrials.gov
Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure
Trial registered· ClinicalTrials.gov
Timing of Empagliflozin in Primary PCI: Pre-Reperfusion Versus Post-Reperfusion Versus Placebo in South Asian STEMI Patients
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 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 & 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.
Results posted· ClinicalTrials.gov
A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastr
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
Trial started· ClinicalTrials.gov
Vascular Effects of SGLT2i in Non-diabetic CKD
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
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
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
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, 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
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
The Role of SGLT2i in Management of Moderate AS
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, Pioglitazone, and Ketone Production in T2D
Primary completion· ClinicalTrials.gov
Comparative Effectiveness of Empagliflozin in the US
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
Trial started· ClinicalTrials.gov
SGLT2i Therapy in Islet Transplantation (SIT)
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 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 acidosi
Label revision· FDA
WARNING: LACTIC ACIDOSIS 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 acidosi
Primary completion· ClinicalTrials.gov
Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations
Trial registered· ClinicalTrials.gov
The Efficacy and Safety of SGLT2Is on Kidney Function, Proteinuria, and Estimated Glomular Filteration Rate (eGFR) in Lupus Nephritis Popula
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.
Results posted· ClinicalTrials.gov
A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alon
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
Trial registered· ClinicalTrials.gov
the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients
Primary completion· ClinicalTrials.gov
Comparative Effectiveness of Empagliflozin in the US
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
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
Primary completion· ClinicalTrials.gov
SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
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
Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity
Primary completion· ClinicalTrials.gov
Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients
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.
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
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.
Label revision· FDA
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
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.
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 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
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
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
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
Effects of Acute and Chronic Empagliflozin Heart Failure
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
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.