Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

Diabetic Neuropathy Peripheral Clinical Trial

Official title:

Clinical Study to Investigate the Possible Effect of Empagliflozin in Treatment of Peripheral Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05977465
• Other study ID #: 35200/1/22
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 20, 2022
• Est. completion date: August 3, 2023

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 3, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy Peripheral
• Peripheral Nervous System Diseases

Intervention

Drug:
• Empagliflozin 25 MG
treatment

Locations

Country	Name	City	State
Egypt	Faculty of pharmacy	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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