Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

Phase 1

Completed

• Conditions: Diabetic Neuropathy Peripheral
• Interventions: Drug: Empagliflozin 25 MG

• Registration Number: NCT05977465
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-20
• Study First Submitted: 2023-07-16
• Study First Submitted QC: 2023-07-28
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-03
• Study First Posted: 2023-08-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Faculty of pharmacy; 🇪🇬 Tanta, Egypt