NCT05558098 (DEFENDER) is a Phase 3 clinical trial of Dapagliflozin 10mg Tab in Critical Illness, sponsored by Hospital Israelita Albert Einstein.

Who is sponsoring NCT05558098?

NCT05558098 is sponsored by Hospital Israelita Albert Einstein.

What drugs are being tested in NCT05558098?

Interventions in NCT05558098: Dapagliflozin 10mg Tab, Standard of Care.

What condition does NCT05558098 study?

NCT05558098 studies Critical Illness, Sepsis.

Is NCT05558098 still recruiting?

NCT05558098 is currently completed. Last updated 31 October 2023.

Last reviewed 2023-10-31 · How we verify

NCT05558098: DEFENDER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dapagliflozin in Patients With Critical Illness

Completed Phase 3 Last updated 31 October 2023

What this trial tests

Phase 3 trial testing Dapagliflozin 10mg Tab in Critical Illness in 507 participants. Completed in 20 October 2023.

Timeline

1 November 2022

Primary endpoint
20 October 2023

20 October 2023

Quick facts

Lead sponsor	Hospital Israelita Albert Einstein
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	507
Start date	1 November 2022
Primary completion	20 October 2023
Estimated completion	20 October 2023
Sites	23 locations across Brazil

Drugs / interventions tested

Dapagliflozin 10mg Tab — full drug profile →
Standard of Care

Conditions studied

Critical Illness — all drugs for Critical Illness →
Sepsis — all drugs for Sepsis →

Sponsor

Hospital Israelita Albert Einstein

Who can join

18 and older, any sex, with Critical Illness or Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To assess the effects of dapagliflozin on a composite hierarchical endpoint in critically ill patients.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

SGLT2 inhibitors: from glucose-lowering to cardiovascular benefits.
Preda A, Montecucco F, Carbone F, Carbone F, et al · · 2024 · cited 76× · PMID 38456601 · DOI 10.1093/cvr/cvae047
Dapagliflozin for Critically Ill Patients With Acute Organ Dysfunction: The DEFENDER Randomized Clinical Trial.
Tavares CAM, Azevedo LCP, Rea-Neto Á, Campos NS, et al · · 2024 · cited 37× · PMID 38873723 · DOI 10.1001/jama.2024.10510
Dapagliflozin in patients with critical illness: rationale and design of the DEFENDER study.
Tavares CAM, Azevedo LCP, Rea-Neto Á, Campos NS, et al · · 2023 · cited 2× · PMID 38133155 · DOI 10.5935/2965-2774.20230129-en
Dapagliflozin in Acute Cardiovascular Conditions: Insights From the DEFENDER Trial.
Tavares CAM, Azevedo LCP, Guimarães PO, Rea-Neto Á, et al · · 2026 · cited 1× · PMID 41421016 · DOI 10.1016/j.jacadv.2025.102459

Verify or expand the search:

Other trials of Dapagliflozin 10mg Tab

Trials testing the same drug.

NCT07056699 — SGLT2i, Pioglitazone, and Ketone Production in T1D · Phase 3 · not yet recruiting
NCT07273838 — Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome · Phase 2 · recruiting
NCT06427226 — Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity · Phase 2 · recruiting
NCT06373523 — MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin · EARLY_PHASE1 · not yet recruiting
NCT06434025 — IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency · Phase 3 · not yet recruiting

Other recruiting trials for Critical Illness

Currently open trials in the same condition.

NCT06189924 — Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients · recruiting
NCT07418242 — Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients · recruiting
NCT07101640 — PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysp · Phase 1, PHASE2 · recruiting
NCT07177183 — Low Serum Creatinine as a Predictor of Prolonged Mechanical Ventilation and Weaning Failure · NA · recruiting
NCT07369258 — Clinical Application of Listening to Music to Prevent Delirium in the Intensive Care Unit · NA · recruiting

Other Hospital Israelita Albert Einstein trials

Trials by the same sponsor.

NCT07447674 — ED Post-Discharge Digital Follow-Up: A Communication Comparison · NA · not yet recruiting
NCT07398222 — Gastric Content in Fasting Volunteers and in Tirzepatide Users: an Observational and Cross-sectional Study · recruiting
NCT07233837 — Hydrogen Peroxide and Ultraviolet Light for Disinfecting Surfaces in Intensive Care Units · NA · recruiting
NCT06726707 — COPPER: A Trial Evaluating Copper-based Products for Incontinence-associated Dermatitis · Phase 2, PHASE3 · withdrawn
NCT07112846 — Prospective Clinical Registry for Evaluation of Exanthematous Infections and Coinfections · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05558098 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hospital Israelita Albert Einstein
Last refreshed: 31 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05558098.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing