Empagliflozin in Treatment of Peripheral Diabetic Neuropathy

NCT05977465 — Phase 1 / Phase 2, Completed, 50 participants, Tanta University

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

Registry	NCT05977465
Status	Completed
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	50 (Actual)
Sponsor	Tanta University (Other)
Conditions	Diabetic Neuropathy Peripheral
Interventions	Empagliflozin 25 MG (Drug)
Dates	start 2022-01-20, primary completion 2023-08-01, completion 2023-08-03, first posted 2023-08-04, last updated 2023-11-24
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Control group	No intervention		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	Drug: Empagliflozin 25 MG	include twenty five patients who will receive Empagloflozin 25 mg once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)

Empagliflozin 25 MG (Drug), also known as empagliflozin tablets: treatment

+Outcome measures

Primary outcomes

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

Sex: All, ages: 18 Years to 65 Years, 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.

+Locations (1)

Facility	City	Country	Status
Faculty of pharmacy	Tanta	Egypt

+Publications

Results publication: El-Haggar SM, Hafez YM, El Sharkawy AM, Khalifa M. Effect of empagliflozin in peripheral diabetic neuropathy of patients with type 2 diabetes mellitus. Med Clin (Barc). 2024 Jul 26;163(2):53-61. doi: 10.1016/j.medcli.2024.01.027. Epub 2024 Apr 22. English, Spanish. PMID 38653618

+Investigators

Maha Khalifa, Pharm D, Principal investigator, Tanta University