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

NCT ID: NCT05373680

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-04-01

Brief Summary

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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

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Conditions

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Renal Insufficiency, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Metformin

Intervention Type 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).

Control

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type 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).

Control

Intervention Type OTHER

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

Control group

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

Group Type OTHER

Control

Intervention Type OTHER

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

Interventions

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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).

Intervention Type 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).

Intervention Type DRUG

Control

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

Intervention Type OTHER

Other Intervention Names

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Biguanide Sodium glucose cotransporter-2 (SGLT2) inhibitor

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role collaborator

Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Bassant Maher Mahboub

Principal Investigator: Bassant Maher Abbas Mahboub, PhD candidate.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Tanta University Teaching Hospitals

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 38837240 (View on PubMed)

Other Identifiers

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34976/10/21

Identifier Type: -

Identifier Source: org_study_id

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