Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

Sponsor

Tanta University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05977465

Collaborator

(none)

Enrollment

Location

Arms

21.4

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

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
Diabetic Neuropathy Peripheral	Drug: Empagliflozin 25 MG	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 treatment Other Names: empagliflozin tablets

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

treatment

Other Names:

empagliflozin tablets

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

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

Sponsors and Collaborators

Tanta University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maha Khalifa, Principal Investigator, Tanta University

ClinicalTrials.gov Identifier:

NCT05977465

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:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Diabetic Neuropathies

Empagliflozin

Study Results

No Results Posted as of Aug 4, 2023