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CompletedNCT05373680Updated Aug 14, 2025

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

A Phase 2/3 interventional study of Metformin and Empagliflozin in Renal Insufficiency, Chronic, sponsored by Tanta University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Tanta University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2024, 2 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 2/3
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Insufficiency, Chronic

Keywords

  • Metformin
  • Empagliflozin
  • Chronic kidney disease
03

In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's enrollment of 118 is above the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
118 participants (actual)

Study arms

  • 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 · Other: Control

  • 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 · Other: Control

  • Other
    Control group

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

    Other: Control

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).

    Also known as: Biguanide

  • 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).

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

  • OtherControl

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

06

What researchers measure

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.

    Time frame: Period of 12 months

Secondary outcomes

  1. 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.

    Time frame: Period of 12 months

07

Study locations

2 sites
  • Mansoura University
    Al Mansurah, Dakahlia Governorate, Egypt
  • Tanta University Teaching Hospitals
    Tanta, Gharbia Governorate, Egypt
08

References and documents

Publications

  • 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;18(1):17. doi: 10.1186/s13098-025-02040-9. PubMed 41373013 ↗
  • 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. PubMed 38837240 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05373680
Lead sponsor
Tanta University
Collaborators
Mansoura University
Responsible party
Bassant Maher Mahboub (Principal Investigator: Bassant Maher Abbas Mahboub, PhD candidate., Tanta University) — Principal investigator
First posted
May 13, 2022
Start date
Jan 1, 2022
Primary completion
Apr 1, 2024
Completion
Apr 1, 2024
Last update
Aug 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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