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

June 9, 2022 updated by: Nidae Alaa

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Internal medicine and endocrinology department, Ain-shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of retinopathy
Time Frame: 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.
12 weeks
Evaluation of the study biomarkers, IL-6, and VEGF
Time Frame: 12 weeks
Interleukin-6 (IL-6)//inflammatory biomarker Vascular endothelial growth factor (VEGF)//angiogenic biomarker
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of adverse events
Time Frame: (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
(1-90)days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nidae Alaa

Investigators

  • Study Director: Lamiaa M ElWakeel, PhD, faculty of pharmacy Ain Shams university
  • Study Director: Marwa A Ahmed, PhD, faculty of pharmacy Ain Shams university
  • Study Director: Mona A Abd El Salam, MD, Faculty of Medicine Ain Shams University
  • Principal Investigator: Nidae A Ismail, BSc, faculty of pharmacy Ain Shams university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

March 27, 2022

First Submitted That Met QC Criteria

March 27, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 311311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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