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

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nidae Alaa
• Treatments: Dapagliflozin; Hypoglycemic Agents

Criteria

Inclusion Criteria:

1. Female or male aged between 40 and 70 years old.

2. Glomerular filtration rates > 60 mL/min.

3. Normal aspartate and alanine transaminase levels.

4. Controlled systolic and diastolic blood pressures

Exclusion Criteria:

1. Patients using insulin or more than one oral anti-diabetic drug.

2. Patients who have HbA1c level ≥10% (86 mmol/mol) or a fasting plasma glucose level >240 mg/dl.

3. Patients with a history of cardiovascular events within six months before enrolment.

4. Patients suffering from cataract or glaucoma.

5. Patients with volume depletion clinical signs.

6. Body mass index (BMI) >40 kg/m2

7. Infectious or inflammatory diseases.

8. Neoplasm, or hematological disorders.

9. Pregnant or breast-feeding patients.

10. Active participation in another clinical study.