EMPAGLIFLOZIN CLINCAL TRIALS LIST
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Here is a comprehensive list of major Empagliflozin Clinical Trials, organized by therapeutic area:
Empagliflozin Major Clinical Trials
🫀 Cardiovascular Outcomes
| Trial | Full Name | Year | Key Finding | PMID |
|---|---|---|---|---|
| EMPA-REG OUTCOME | Empagliflozin Cardiovascular Outcome Event Trial in T2DM Patients | 2015 | Significant reduction in CV death, HF hospitalization, and all-cause mortality in T2DM with established CVD | 26378978 |
🫀 Heart Failure — Reduced Ejection Fraction (HFrEF)
| Trial | Full Name | Year | Key Finding | PMID |
|---|---|---|---|---|
| EMPEROR-Reduced | Empagliflozin Outcome Trial in Patients with Chronic Heart Failure and a Reduced Ejection Fraction | 2020 | Reduced composite of CV death or HF hospitalization in HFrEF (with or without T2DM) | 32865377 |
🫀 Heart Failure — Preserved Ejection Fraction (HFpEF)
| Trial | Full Name | Year | Key Finding | PMID |
|---|---|---|---|---|
| EMPEROR-Preserved | Empagliflozin Outcome Trial in Patients with Chronic Heart Failure and a Preserved Ejection Fraction | 2021 | First drug to reduce CV death/HF hospitalization in HFpEF | 34449189 |
🏥 Acute Heart Failure
| Trial | Full Name | Year | Key Finding | PMID |
|---|---|---|---|---|
| EMPULSE | Empagliflozin in Acute Heart Failure | 2022 | Clinical benefit (composite of death, HF events, symptom improvement) when started in-hospital | 35228754 |
| EMPULSE (Decongestion sub-study) | Impact of empagliflozin on decongestion in acute HF | 2023 | Superior decongestion vs. placebo in acute HF | 36254693 |
❤️🔥 Acute Myocardial Infarction
| Trial | Full Name | Year | Key Finding | PMID |
|---|---|---|---|---|
| EMMY | Empagliflozin in Acute Myocardial Infarction | 2022 | Reduced NT-proBNP and improved cardiac remodeling post-MI | 36036746 |
| EMPACT-MI | Empagliflozin After Acute Myocardial Infarction | 2024 | Did not significantly reduce composite of HF hospitalization/death post-MI | 38587237 |
🫘 Kidney Disease
| Trial | Full Name | Year | Key Finding | PMID |
|---|---|---|---|---|
| EMPA-REG OUTCOME (renal sub-study) | Empagliflozin and Progression of Kidney Disease in T2DM | 2016 | Slowed kidney disease progression, reduced incident/worsening nephropathy | 27299675 |
| EMPA-KIDNEY | Empagliflozin in Chronic Kidney Disease (broader CKD) | 2023 | Reduced kidney disease progression and CV death across broad CKD spectrum (incl. non-diabetic) | 36331190 |
| EMPA-KIDNEY (CKD progression analysis) | Effects on progression of CKD — prespecified secondary analysis | 2024 | Confirmed sustained benefit in slowing eGFR decline | 38061371 |
| EMPA-KIDNEY (primary disease subgroup) | Impact by primary kidney disease subtype | 2024 | Benefit consistent across diabetic and non-diabetic CKD etiologies | 38061372 |
| EMPA-KIDNEY (long-term) | Long-Term Effects of Empagliflozin in CKD | 2025 | Durable kidney-protective effects over extended follow-up | 39453837 |
💊 Combination Therapy in CKD
| Trial | Full Name | Year | Key Finding | PMID |
|---|---|---|---|---|
| CONFIDENCE | Finerenone + Empagliflozin in CKD + T2DM (Phase II) | 2025 | Combination reduced UACR more than either agent alone | 40470996 |
| Aldosterone synthase inhibitor + Empagliflozin | Aldosterone synthase inhibition ± empagliflozin in CKD (Phase II) | 2024 | Additive antiproteinuric effect | 38109916 |
🧪 Diabetes — Glycemic Control
| Trial | Full Name | Year | Key Finding | PMID |
|---|---|---|---|---|
| PIONEER 2 | Oral Semaglutide vs. Empagliflozin in T2DM (PIONEER 2) | 2019 | Oral semaglutide superior HbA1c reduction vs. empagliflozin | 31530666 |
| EMPA-ELDERLY | Empagliflozin in Elderly Japanese Adults ≥65 with T2DM | 2023 | Efficacious and safe over 52 weeks in elderly patients | 37622398 |
| DINAMO | Empagliflozin vs. Linagliptin in Youth with T2DM (Phase III) | 2023 | First SGLT2i trial in pediatric T2DM; empagliflozin showed HbA1c reduction vs. placebo | 36738751 |
🧂 SIADH / Hyponatremia
| Trial | Full Name | Year | Key Finding | PMID |
|---|---|---|---|---|
| SIADH Trial | Empagliflozin to increase plasma sodium in SIAD | 2020 | Significantly raised serum sodium in SIADH | 32019783 |
Trial Acronym Quick Reference
| Acronym | Stands For |
|---|---|
| EMPA-REG OUTCOME | EMPAgliflozin cardiovascular REGistry OUTCOME |
| EMPEROR-Reduced | EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure with reduced ejection fraction |
| EMPEROR-Preserved | Same program — preserved EF arm |
| EMPULSE | EMPaglifloziN in acute heart failURE |
| EMMY | EMpagliflozin in acute MYocardial infarction |
| EMPACT-MI | EMPAglifloziN in Patients After aCuTe Myocardial Infarction |
| EMPA-KIDNEY | EMPAgliflozin in patients with chronic KIDNEY disease |
| DINAMO | Drug Interventions in Not Adequately controlled type 2 diabetes in youth using a Metformin background therapy with Oral semaglutide or empagliflozin |
| CONFIDENCE | COmbinatioN effect of FInerenone anD EmpaglifloziN |
Total RCT database: 509 empagliflozin RCTs indexed in PubMed as of April 2026. The above represents the landmark trials that shaped current clinical guidelines.
dapagliflozin defender trial
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dapagliflozin DEFENDER trial
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dapagliflozin DEFENDER trial results
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DEFENDER Trial — Dapagliflozin in Critical Illness
Full Name: Dapagliflozin for Critically Ill Patients With Acute Organ Dysfunction
Published: JAMA, August 6, 2024 | PMID: 38873723 | DOI: 10.1001/jama.2024.10510
Background / Rationale
SGLT2 inhibitors have proven benefits in T2DM, heart failure, and chronic kidney disease. DEFENDER was designed to test whether dapagliflozin could also improve outcomes in the critically ill — a population with acute multiorgan dysfunction where SGLT2i had never been formally evaluated.
Design
| Feature | Details |
|---|---|
| Design | Multicenter, randomized, open-label clinical trial |
| Sites | 22 ICUs in Brazil |
| Enrollment | Nov 2022 – Aug 2023 |
| Participants | 507 adults with unplanned ICU admission + ≥1 organ dysfunction (respiratory, cardiovascular, or kidney) |
| Intervention | Dapagliflozin 10 mg/day + standard care (n=248) vs. standard care alone (n=259) for up to 14 days or ICU discharge |
| ClinicalTrials.gov | NCT05558098 |
Patient Profile
- Mean age: 63.9 years (SD 15)
- Women: 46.9%
- ~40% admitted for suspected infection (sepsis)
- Median time from ICU admission to randomization: 1 day
Primary Outcome
Hierarchical composite of:
- Hospital mortality
- Initiation of kidney replacement therapy (KRT)
- ICU length of stay through 28 days
Analyzed using the win ratio method.
Results
| Outcome | Dapagliflozin | Control | Result |
|---|---|---|---|
| Primary (Win Ratio) | — | — | 1.01 (95% CI 0.90–1.13; p=0.89) → No significant benefit |
| KRT initiated | 10.9% (27 pts) | 15.1% (39 pts) | Probability of benefit: 0.90 (numerically favorable, not definitive) |
Conclusion
Adding dapagliflozin to standard ICU care did not improve clinical outcomes in critically ill patients with acute organ dysfunction. However, confidence intervals were wide and could not exclude relevant benefits or harms, leaving the door open for future, adequately powered trials.
Post-Hoc / Secondary Analyses Published
| Paper | Focus | PMID |
|---|---|---|
| Secondary analysis (2025) | Effects on urinary output, fluid balance, and biochemistry | 40646628 |
| Commentary (2025) | Implications for clinicians (nephrology perspective) | 39814582 |
| Cardiovascular subgroup analysis (2026) | Insights from acute cardiovascular conditions subgroup | 41421016 |
Clinical Significance
DEFENDER is the first large RCT testing an SGLT2 inhibitor in the ICU setting. The neutral result was somewhat expected given the underpowered sample (507 pts), heterogeneous population, and short treatment window (≤14 days). The signal toward reduced KRT use (10.9% vs 15.1%) is hypothesis-generating and may support future trials focused specifically on AKI prevention in critical illness.
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