Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

Tanta University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetic Neuropathy Peripheral

Treatments: Drug: Empagliflozin 25 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05977465

35200/1/22

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control group

No Intervention group

Description:

include twenty-five patients who will receive placebo tablets once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)

Empagliflozin group

Experimental group

Description:

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

Treatment:

Drug: Empagliflozin 25 MG