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

Sponsor

Nidae Alaa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05310916

Collaborator

(none)

Enrollment

Location

Arms

16.9

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Drug: Dapagliflozin 10mg Tab plus another oral hypoglycemic agent Drug: Two oral hypoglycemic agents other than dapagliflozin	Phase 3

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:

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:

Clinical Evaluation
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
Follow up

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 6, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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. Other Names: Diglifloz 10mg Tab
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 Other Names: Oral anti-diabetic agents

Arm

Intervention/Treatment

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.

Other Names:

Diglifloz 10mg Tab

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

Other Names:

Oral anti-diabetic agents

Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Internal medicine and endocrinology department, Ain-shams university hospitals	Cairo		Egypt

Sponsors and Collaborators

Nidae Alaa

Investigators

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