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

  • End date
    Nov 5, 2023
  • participants needed
  • sponsor
    Nidae Alaa
Updated on 5 July 2022
type 2 diabetes mellitus
hypoglycemic agents
oral hypoglycemic
antidiabetic drugs


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.


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
  2. Systolic and diastolic blood pressures recording.
  3. Plasma glucose measurement.
  4. Report any adverse effects that may appear
  5. Blood samples will be taken at baseline and at 12-week visits
  6. Follow up

Condition Diabetic Retinopathy
Treatment Dapagliflozin 10mg Tab plus another oral hypoglycemic agent, Two oral hypoglycemic agents other than dapagliflozin
Clinical Study IdentifierNCT05310916
SponsorNidae Alaa
Last Modified on5 July 2022


Yes No Not Sure

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
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