Clinical Study to Investigate the Possible Effect of Empagliflozin in Treatment of Peripheral Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2
Overview
- Phase
- Phase 1
- Intervention
- Empagliflozin 25 MG
- Conditions
- Diabetic Neuropathy Peripheral
- Sponsor
- Tanta University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Maha Khalifa
Principal Investigator
Tanta University
Eligibility Criteria
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 m
- •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.
Arms & Interventions
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)
Intervention: Empagliflozin 25 MG
Outcomes
Primary Outcomes
Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities.
Time Frame: 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 %
Time Frame: 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.