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

NCT05373680 | Completed Phase 2 FDA Drug

• 1 other identifier: 34976/10/21
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Insufficiency, Chronic

Keywords

Metformin; Empagliflozin; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Change in estimated glomerular filtration rate (eGFR) values from baseline

  This will be achieved by measuring the serum creatinine levels and then eGFR values will be calculated.

  Period of 12 months

Secondary Outcomes (1)

• Change in albumin or protein excretion values from baseline

  Period of 12 months

Study Arms (3)

Metformin treatment group

EXPERIMENTAL

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.

Drug: Metformin; Other: Control

Empagliflozin treatment group

EXPERIMENTAL

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.

Drug: Empagliflozin; Other: Control

Control group

OTHER

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

Other: Control

Interventions

Metformin DRUG

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).

Also known as: Biguanide

Metformin treatment group

Empagliflozin DRUG

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).

Also known as: Sodium glucose cotransporter-2 (SGLT2) inhibitor

Empagliflozin treatment group

Control OTHER

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

Control group; Empagliflozin treatment group; Metformin treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead
• Mansoura University: collaborator

Study Sites (2)

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

Tanta University Teaching Hospitals

Tanta, Gharbia Governorate, Egypt

Location

Related Publications (2)

• Mahboub BM, Refaie AF, El-Haggar SM, Hafez YM, Mostafa TM. Efficacy and safety of metformin versus empagliflozin on chronic kidney disease progression (MET-EMPA-CKD): a randomized controlled trial. Diabetol Metab Syndr. 2025 Dec 10. doi: 10.1186/s13098-025-02040-9. Online ahead of print.

  PMID: 41373013 DERIVED

• El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.

  PMID: 38837240 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Metformin; Biguanides; empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Bassant Maher Abbas Mahboub, PhD candidate.

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: May 13, 2022
• Study Start: January 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 14, 2025

Record last verified: 2023-04

Locations

EG (2)