Clinical trial
Clinical Study to Investigate the Possible Effect of Empagliflozin in Treatment of Peripheral Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2
Name
35200/1/22
Description
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.
Trial arms
Trial start
2022-01-20
Estimated PCD
2023-08-01
Trial end
2023-08-03
Status
Completed
Phase
Early phase I
Treatment
Empagliflozin 25 MG
treatment
Arms:
Empagliflozin group
Other names:
empagliflozin tablets
Size
50
Primary endpoint
Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities.
change from baseline at three month
Change in HbA1c %
change from baseline at three months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-11-24
1 organization
1 product
1 indication
Organization
Tanta UniversityProduct
EmpagliflozinIndication
Diabetic Neuropathy Peripheral