Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

Tanta University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Neuropathy Peripheral

Interventions

Empagliflozin 25 MGDRUG

treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of pharmacy

Tanta, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: change from baseline at three months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.