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

Tanta University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Renal Insufficiency, Chronic

Treatments: Drug: Empagliflozin; Drug: Metformin; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05373680

34976/10/21

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 3 patient groups

Metformin treatment group

Experimental group

Description:

In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive metformin 1000 mg PO daily added to their usual therapy.

Treatment:

Other: Control

Drug: Metformin

Empagliflozin treatment group

Experimental group

Description:

In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive empagliflozin 10 mg daily PO added to their usual therapy.

Treatment:

Other: Control

Drug: Empagliflozin

Control group

Other group

Description:

In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy.

Treatment:

Other: Control