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Completed

NCT Number: NCT05977465

Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

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.

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Key information

Conditions

Diabetic Neuropathy Peripheral

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Faculty of pharmacy

Tanta, 31111, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Empagliflozin 25 MG

Drug

treatment

Other names: empagliflozin tablets

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2023
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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