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

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic
• Intervention / Treatment: Drug: Metformin; Drug: Empagliflozin; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Governorate
    • Mansoura, Dakahlia Governorate, Egypt
      • Mansoura University
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt
      • Tanta University Teaching Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metformin treatment group; 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; 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).; Other Names: Biguanide; Other: Control; Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).
Experimental: Empagliflozin treatment group; 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; 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).; Other Names: Sodium glucose cotransporter-2 (SGLT2) inhibitor; Other: Control; Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).
Other: Control group; In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy.	Other: Control; Patients will receive their usual therapy for the management of CKD (including the management of predisposing causes with other supportive care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in albumin or protein excretion values from baseline	This will be achieved by measuring the urinary albumin or protein:creatinine ratio from a spot urine test in a morning sample.	Period of 12 months

Collaborators and Investigators

• Sponsor: Tanta University
• Collaborators: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Metformin; Empagliflozin; Chronic kidney disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Disease Progression; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Empagliflozin; Metformin; Biguanides
• Other Study ID Numbers: 34976/10/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes