Effect of SGLT2i on Diabetic Retinopathy in Type 2 Diabetes Mellitus Patients

Study Overview
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Brief Summary
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A prospective, randomized, open-label, controlled clinical trial will be conducted at the endocrinology department - Ain Shams University (ASU) hospital. Sixty patients will be enrolled into the study. 30 of which will receive dapagliflozin 10mg tab once daily and the other thirty will receive their standard antidiabetic therapy for 12 weeks.

Detailed Description
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All type 2 diabetes mellitus patients presenting to the endocrinology department, ASU Hospitals, who were diagnosed with mild to moderate non-proliferative diabetic retinopathy will be assessed for eligibility. Eligible patients will be randomly assigned to one of the following 2 arms: Group 1 (Control group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic for 12 weeks. Group 2 (Test group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic along with dapagliflozin at a dose of 10 mg daily for 12 weeks. A total of four visits one for baseline evaluation and one for end of study evaluation and two intermediate visits, the following will be performed in the visits: Clinical Evaluation Systolic and diastolic blood pressures recording. Plasma glucose measurement. Report any adverse effects that may appear Blood samples will be taken at baseline and at 12-week visits Follow up

Official Title
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Evaluation of the Effect of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors on Diabetic Retinopathy in Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Drug: Dapagliflozin 10mg Tab plus another oral hypoglycemic agent
* Drug: Two oral hypoglycemic agents other than dapagliflozin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male aged between 40 and 70 years old. Glomerular filtration rates > 60 mL/min. Normal aspartate and alanine transaminase levels. Controlled systolic and diastolic blood pressures Exclusion Criteria: Patients using insulin or more than one oral anti-diabetic drug. Patients who have HbA1c level ≥10% (86 mmol/mol) or a fasting plasma glucose level >240 mg/dl. Patients with a history of cardiovascular events within six months before enrolment. Patients suffering from cataract or glaucoma. Patients with volume depletion clinical signs. Body mass index (BMI) >40 kg/m2 Infectious or inflammatory diseases. Neoplasm, or hematological disorders. Pregnant or breast-feeding patients. Active participation in another clinical study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>(n=30): type 2 diabetes mellitus patients who will receive an oral antidiabetic along with dapagliflozin at a dose of 10 mg daily for 12 weeks. | Drug: Dapagliflozin 10mg Tab plus another oral hypoglycemic agent<br>* Dapagliflozin is a member of Sodium-glucose co-transporter 2 inhibitors class which in addition to its glucose control effect, has reno-protective and cardioprotective effects, controls blood pressure and causes weight loss.<br>* Other names: Diglifloz 10mg Tab;|
| Active Comparator: Control group<br>(n=30): type 2 diabetes mellitus patients who will receive two oral antidiabetic agents for 12 weeks | Drug: Two oral hypoglycemic agents other than dapagliflozin<br>* Two oral anti-diabetic agents not including sodium-glucose co-transporter 2 inhibitors<br>* Other names: Oral anti-diabetic agents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic retinopathy, Sodium-glucose cotransporter-2 inhibitor