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

Phase 2

Recruiting

• Conditions: Renal Insufficiency, Chronic
• Interventions: Drug: Metformin; Drug: Empagliflozin; Other: Control

• Registration Number: NCT05373680
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-01
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin treatment group	Control	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.
Control group	Control	In this arm, patients with chronic kidney disease who meet study inclusion criteria will receive their usual therapy.
Empagliflozin treatment group	Control	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.
Metformin treatment group	Metformin	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.
Empagliflozin treatment group	Empagliflozin	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.

Primary Outcome Measures

Name	Time	Method
Change in estimated glomerular filtration rate (eGFR) values from baseline	Period of 12 months	This will be achieved by measuring the serum creatinine levels and then eGFR values will be calculated.
Change in albumin or protein excretion values from baseline	Period of 12 months	This will be achieved by measuring the urinary albumin or protein:creatinine ratio from a spot urine test in a morning sample.

Trial Locations

Locations (2)

Mansoura University; 🇪🇬 Mansoura, Dakahlia Governorate, Egypt

Tanta University Teaching Hospitals; 🇪🇬 Tanta, Gharbia Governorate, Egypt