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

Sponsor
Nidae Alaa
Study ID
NCT05310916
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 6, 2022
Status verified
Jun 2022
Primary completion
May 31, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • Active Comparator: Control group
    (n=30): type 2 diabetes mellitus patients who will receive two oral antidiabetic agents for 12 weeks

Primary Outcome Measure

Severity of retinopathy [ Time Frame: 12 weeks ]

Central Contacts

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