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Efficacy and Safety of Metformin Versus Empagliflozin on Chronic Kidney Disease Progression

Clinical Study Evaluating the Efficacy and Safety of Metformin Versus Empagliflozin for Halting Chronic Kidney Disease Progression

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05373680
Enrollment
118
Registered
2022-05-13
Start date
2022-01-01
Completion date
2024-04-01
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency, Chronic

Keywords

Metformin, Empagliflozin, Chronic kidney disease

Brief summary

This randomized controlled trial aims at evaluating the efficacy and safety of the antidiabetics metformin versus empagliflozin on chronic kidney disease (CKD) progression in patients with CKD stages 2 or/and 3.

Interventions

DRUGMetformin

Patients will receive metformin 1000 mg PO daily added to their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).

DRUGEmpagliflozin

Patients will receive empagliflozin 10 mg daily PO added to their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).

OTHERControl

Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).

Sponsors

Mansoura University
CollaboratorOTHER
Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients with mild or/and moderate chronic kidney disease (stages 2 or/and 3, estimated glomerular filtration rate (eGFR) between 30-89 ml/min/1.73 m2) at the time of the baseline visit. * Patients with and without type 2 diabetes. * Patients with or without proteinuria. * Age: ≥ 18 years.

Exclusion criteria

* Type 1 diabetes. * Patients with eGFR ˂30 ml/min/1.73 m2. * Patients with known hepatic cell failure. * Decompensated heart requiring acute management. * Active malignancy. * Planned coronary or surgical interventions. * Known hypersensitivity to study medications. * Chronic inflammation, trauma, or infection. * Pregnant or lactating women. * Patients already on metformin or a sodium-glucose cotransporter-2 (SGLT2) inhibitor. * Any of the study treatments labeled contraindications.

Design outcomes

Primary

MeasureTime frameDescription
Change in estimated glomerular filtration rate (eGFR) values from baselinePeriod of 12 monthsThis will be achieved by measuring the serum creatinine levels and then eGFR values will be calculated.

Secondary

MeasureTime frameDescription
Change in albumin or protein excretion values from baselinePeriod of 12 monthsThis will be achieved by measuring the urinary albumin or protein:creatinine ratio from a spot urine test in a morning sample.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026