MedTrace Logo

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

NCT05310916 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-06-10

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Two oral hypoglycemic agents other than dapagliflozin

Two oral anti-diabetic agents not including sodium-glucose co-transporter 2 inhibitors

Sponsors & Collaborators

  • Nidae Alaa

    lead OTHER

Principal Investigators

  • Lamiaa M ElWakeel, PhD · Faculty of pharmacy Ain Shams University

  • Mona A Abd El Salam, MD · Faculty of Medicine Ain Shams University

  • Marwa A Ahmed, PhD · Faculty of pharmacy Ain Shams University

  • Nidae A Ismail, BSc · Faculty of pharmacy Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-06
Primary Completion
2023-05-31
Completion
2023-11-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05310916 on ClinicalTrials.gov