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

April 12, 2023 updated by: Bassant Maher Mahboub, Tanta University

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Mansoura, Dakahlia Governorate, Egypt
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt
        • Recruiting
        • Tanta University Teaching Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Period of 12 months
This will be achieved by measuring the serum creatinine levels and then eGFR values will be calculated.
Period of 12 months
Change in albumin or protein excretion values from baseline
Time Frame: 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.
Period of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Collaborators

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

June 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)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34976/10/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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