Effect of SGLT2i on Diabetic Retinopathy in Type 2 Diabetes Mellitus Patients
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.
|Condition or Disease||Intervention/Treatment||Phase|
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:
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
Arms and Interventions
|Experimental: Test group
(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
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.
|Active Comparator: Control group
(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
Two oral anti-diabetic agents not including sodium-glucose co-transporter 2 inhibitors
Primary Outcome Measures
- Severity of retinopathy [12 weeks]
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.
- Evaluation of the study biomarkers, IL-6, and VEGF [12 weeks]
Interleukin-6 (IL-6)//inflammatory biomarker Vascular endothelial growth factor (VEGF)//angiogenic biomarker
Secondary Outcome Measures
- Occurrence of adverse events [(1-90)days]
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
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
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
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.
Contacts and Locations
|1||Internal medicine and endocrinology department, Ain-shams university hospitals||Cairo||Egypt|
Sponsors and Collaborators
- Nidae Alaa
- Study Director: Lamiaa M ElWakeel, PhD, Faculty of pharmacy Ain Shams University
- Study Director: Mona A Abd El Salam, MD, Faculty of Medicine Ain Shams University
- Study Director: Marwa A Ahmed, PhD, Faculty of pharmacy Ain Shams University
- Principal Investigator: Nidae A Ismail, BSc, Faculty of pharmacy Ain Shams University
Study Documents (Full-Text)None provided.
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