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

Sponsor
Nidae Alaa (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05310916
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
18
Anticipated Duration (Months)
3.3
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 DiseaseIntervention/TreatmentPhase
  • 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:
  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

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
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

ArmIntervention/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

    1. Severity of retinopathy [12 weeks]

      evaluate the change of stage of disease according to diabetic retinopathy severity scale

    2. 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

    1. 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:
    No
    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.

    1. Patients with a history of cardiovascular events within six months before enrolment.

    2. Patients suffering from cataract or glaucoma.

    3. Patients with volume depletion clinical signs.

    4. Body mass index (BMI) >40 kg/m2

    5. Infectious or inflammatory diseases.

    6. Neoplasm, or hematological disorders.

    7. Pregnant or breast-feeding patients.

    8. Active participation in another clinical study.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Internal medicine and endocrinology department, Ain-shams university hospitalsCairoEgypt

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Nidae Alaa, Bachelor of Pharmacy, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05310916
    Other Study ID Numbers:
    • 311311
    First Posted:
    Apr 5, 2022
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nidae Alaa, Bachelor of Pharmacy, Ain Shams University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 5, 2022