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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | include twenty five patients who will receive Empagloflozin 25 mg once daily for three months, plus their antidiabetic drugs ( Dpp4 inhibitor and metformin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 MG | Drug | treatment |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 from baseline at three month |
| 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. | change from baseline at three months |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Maha Khalifa, Pharm D | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of pharmacy | Tanta | 31111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38653618 | Derived | 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. |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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