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 |
