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Clinical Trial Details

Trial ID: L3399
Source ID: NCT05310916
Associated Drug: Dapagliflozin 10mg Tab Plus Another Oral Hypoglycemic Agent
Title: Effect of SGLT2i on Diabetic Retinopathy in Type 2 Diabetes Mellitus Patients
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetic Retinopathy
Interventions: DRUG: Dapagliflozin 10mg Tab plus another oral hypoglycemic agent|DRUG: Two oral hypoglycemic agents other than dapagliflozin
Outcome Measures: Primary: Severity of retinopathy, evaluate the change of stage of disease according to diabetic retinopathy severity scale,, Which is the International Clinical Disease Severity Scale (ICDSS) for DR. This scale classified the severity of disease into five stages ( No apparent retinopathy, Mild Non proliferative Diabetic retinopathy (NPDR) ,Mod NPDR, Severe NPDR ,Proliferative Diabetic Retinopathy) depend on eye examination. higher scores mean worse outcome., 12 weeks|Evaluation of the study biomarkers, IL-6, and VEGF, Interleukin-6 (IL-6)//inflammatory biomarker Vascular endothelial growth factor (VEGF)//angiogenic biomarker, 12 weeks | Secondary: Occurrence of adverse events, No potential risks are expected when the study patients are selected according to the determined inclusion criteria but maybe occur Nausea, abdominal pain, polyuria, thrush, genital or urinary tract infections, (1-90)days
Sponsor/Collaborators: Sponsor: Nidae Alaa
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2022-06-06
Completion Date: 2023-11
Results First Posted:
Last Update Posted: 2022-06-10
Locations: Internal medicine and endocrinology department, Ain-shams university hospitals, Cairo, Egypt
URL: https://clinicaltrials.gov/show/NCT05310916