Back to resultsEmpagliflozin in Treatment of Peripheral Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathy Peripheral
Status
Active
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Empagliflozin 25 MG
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy Peripheral
Eligibility Criteria
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.
Sites / Locations
- Faculty of pharmacy
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Empagliflozin group
Arm Description
include twenty-five patients who will receive placebo tablets once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)
include twenty five patients who will receive Empagloflozin 25 mg once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)
Outcomes
Primary Outcome Measures
Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities.
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 %
HbA1c % will be assayed in whole blood using an automated System (H.P.L.C model: G89051, Tosoh, USA), for the two studied groups.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05977465
Brief Title
Empagliflozin in Treatment of Peripheral Diabetic Neuropathy
Official Title
Clinical Study to Investigate the Possible Effect of Empagliflozin in Treatment of Peripheral Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy Peripheral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
include twenty-five patients who will receive placebo tablets once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)
Arm Title
Empagliflozin group
Arm Type
Experimental
Arm Description
include twenty five patients who will receive Empagloflozin 25 mg once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin)
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 25 MG
Other Intervention Name(s)
empagliflozin tablets
Intervention Description
treatment
Primary Outcome Measure Information:
Title
Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities.
Description
The electrophysiological studies will be performed using Nihon Kohden Neuropack, six-channel apparatus (Nihon Kohden, Japan) using surface electrodes, for the two studied groups.
Time Frame
change from baseline at three month
Title
Change in HbA1c %
Description
HbA1c % will be assayed in whole blood using an automated System (H.P.L.C model: G89051, Tosoh, USA), for the two studied groups.
Time Frame
change from baseline at three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha Khalifa, Pharm D
Organizational Affiliation
Faculty of Pharmacy, Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of pharmacy
City
Tanta
ZIP/Postal Code
31111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Empagliflozin in Treatment of Peripheral Diabetic Neuropathy
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