Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

Tanta University (Other)
Overall Status
Active, not recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

The aim of the study is to investigate the possible protective effect of empagliflozin in patients with type 2 diabetes mellitus with diabetic peripheral neuropathy and not on SGLT2 inhibitors treatment.

Condition or Disease Intervention/Treatment Phase
  • Drug: Empagliflozin 25 MG
Phase 1/Phase 2

Study Design

Study Type:
Anticipated Enrollment :
50 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Clinical Study to Investigate the Possible Effect of Empagliflozin in Treatment of Peripheral Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2
Actual Study Start Date :
Jan 20, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

include twenty-five patients who will receive placebo tablets once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)

Experimental: Empagliflozin group

include twenty five patients who will receive Empagloflozin 25 mg once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)

Drug: Empagliflozin 25 MG
Other Names:
  • empagliflozin tablets
  • Outcome Measures

    Primary Outcome Measures

    1. Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities. [change from baseline at three month]

      The electrophysiological studies will be performed using Nihon Kohden Neuropack, six-channel apparatus (Nihon Kohden, Japan) using surface electrodes, for the two studied groups.

    2. Change in HbA1c % [change from baseline at three months]

      HbA1c % will be assayed in whole blood using an automated System (H.P.L.C model: G89051, Tosoh, USA), for the two studied groups.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:

    Patients with type 2 diabetes mellitus (Hba1c 7 %- 9%). Patients receiving dipeptidyl peptidase-4 inhibitors, metformin ± basal insulin.

    Patients with peripheral neuropathy and not on SGLT2 inhibitor treatment. Patients aged between 18 years old to 65 years old.

    Exclusion Criteria:
    • Breastfeeding female.

    • Pregnant female.

    • Estimated Glomerular Filtration Rate less than 45 mL/minute/1.73 m2.

    • Patients with type 1 diabetes mellitus.

    • Patients with diabetic ketoacidosis.

    • Patients with urinary tract infections.

    • Dehydrated patients till normalized.

    • Lower limb amputation patients.

    • SGLT2 inhibitors hypersensitivity.

    • Severe hepatic patients.

    • Patients on neuroprotective drugs.

    Contacts and Locations


    Site City State Country Postal Code
    1 Faculty of pharmacy Tanta Egypt 31111

    Sponsors and Collaborators

    • Tanta University


    • Principal Investigator: Maha Khalifa, Pharm D, Faculty of Pharmacy, Tanta University

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Maha Khalifa, Principal Investigator, Tanta University
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • 35200/1/22
    First Posted:
    Aug 4, 2023
    Last Update Posted:
    Aug 4, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 4, 2023