Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

NCT05977465 | Completed Phase 1 DMC

• 1 other identifier: 35200/1/22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy Peripheral

Outcome Measures

Primary Outcomes (2)

• Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities.

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

  change from baseline at three month

• Change in HbA1c %

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

  change from baseline at three months

Study Arms (2)

Control group

NO INTERVENTION

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

Empagliflozin group

EXPERIMENTAL

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

Interventions

Empagliflozin 25 MG DRUG

treatment

Also known as: empagliflozin tablets

Empagliflozin group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of pharmacy

Tanta, 31111, Egypt

Location

Related Publications (1)

• El-Haggar SM, Hafez YM, El Sharkawy AM, Khalifa M. Effect of empagliflozin in peripheral diabetic neuropathy of patients with type 2 diabetes mellitus. Med Clin (Barc). 2024 Jul 26;163(2):53-61. doi: 10.1016/j.medcli.2024.01.027. Epub 2024 Apr 22. English, Spanish.

  PMID: 38653618 DERIVED

MeSH Terms

Interventions

empagliflozin

Study Officials

• Maha Khalifa, Pharm D

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 4, 2023
• Study Start: January 20, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 3, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)