Empagliflozin in Treatment of Peripheral Diabetic Neuropathy
NCT ID: NCT05977465
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2022-01-20
2023-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
include twenty-five patients who will receive placebo tablets once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)
No interventions assigned to this group
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)
Empagliflozin 25 MG
treatment
Interventions
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Empagliflozin 25 MG
treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Patients with peripheral neuropathy and not on SGLT2 inhibitor treatment. Patients aged between 18 years old to 65 years old.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Tanta University
OTHER
Responsible Party
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Maha Khalifa
Principal Investigator
Principal Investigators
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Maha Khalifa, Pharm D
Role: PRINCIPAL_INVESTIGATOR
Tanta University
Locations
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Faculty of pharmacy
Tanta, , Egypt
Countries
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References
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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.
Other Identifiers
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35200/1/22
Identifier Type: -
Identifier Source: org_study_id