NCT05310916

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Nidae Alaa · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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: 1. Group 1 (Control group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic for 12 weeks. 2. 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: 1. Clinical Evaluation 1. Systolic and diastolic blood pressures recording. 2. Plasma glucose measurement. 2. Report any adverse effects that may appear 3. Blood samples will be taken at baseline and at 12-week visits 4. Follow up

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10mg Tab plus another oral hypoglycemic agent	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.
DRUG	Two oral hypoglycemic agents other than dapagliflozin	Two oral anti-diabetic agents not including sodium-glucose co-transporter 2 inhibitors

Timeline

• Start date: 2022-06-06
• Primary completion: 2023-05-01
• Completion: 2023-11-01
• First posted: 2022-04-05
• Last updated: 2022-06-10

Locations

1 site across 1 country: Egypt