Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

Sponsor
Tanta University
Study ID
NCT05977465
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Diabetic Neuropathy Peripheral

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 20, 2022
Status verified
Nov 2023
Primary completion
Aug 1, 2023
Completion
Aug 3, 2023

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities. [ Time Frame: change from baseline at three month ]