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

Nidae Alaa

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Retinopathy

Treatments: Drug: Two oral hypoglycemic agents other than dapagliflozin; Drug: Dapagliflozin 10mg Tab plus another oral hypoglycemic agent

Study type: Interventional

Funder types: Other

Identifiers

NCT05310916

311311

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Test group

Experimental group

Description:

(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.

Treatment:

Drug: Dapagliflozin 10mg Tab plus another oral hypoglycemic agent

Control group

Active Comparator group

Description:

(n=30): type 2 diabetes mellitus patients who will receive two oral antidiabetic agents for 12 weeks

Treatment:

Drug: Two oral hypoglycemic agents other than dapagliflozin