Adding SGLt2 Inhibitors to Patients With Type 2 Diabetes

September 6, 2026 updated by: Caroline Refaat labib, Assiut University

Efficacy and Safety of Incorporating Sodium-glucose Cotransporter-2 Inhibitors to Regimens of Patients With Type 2 Diabetes

To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes.

- To detect the side-effects of SGLT2i

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes mellitus (T2DM) is a worldwide health problem, with a continuously increasing prevalence . Good management of blood glucose level is critical to delay progression of the underlying metabolic dysfunction and to reduce the risk of diabetic complications . Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are a new class of antidiabetic drug acting by increasing urinary glucose excretion. First approved in 2014, SGLT2i have been widely used to treat patients with type 2 diabetes They are effective in reducing blood glucose, and surprisingly have shown benefits beyond glycaemic control .

Physicians have reported improved hypertension, heart failure, chronic kidney disease, fatty liver disease and obesity However, SGLT inhibitors are not magical drugs, and their use is not free of side effects ( Reported side effects include urinary tract infections, genital infection, dehydration, and hypotension, plus the usual side effects of antidiabetic medications as hypoglycemia . The optimum practical guideline for adding SGLT2 inhibitors to treatment regimens of patients with diabetes is controversial .Many local guidelines and treatment policies exist, yet we need to develop our own local policy at Assiut University hospitals to suit our patients needs and expectations, balancing between efficacy and side effects.

Study Type

Interventional

Enrollment (Actual)

482

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Egypt
      • Asyut, Egypt
        • Assiut University hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Adult diabetic type 2patients

Description

Inclusion Criteria:

  1. Adults (≥18 years)
  2. both genders ( male and female)
  3. type 2 diabetic patients

Exclusion Criteria:

  1. history of severe hypoglycemia
  2. patients with history of weight loss
  3. Patients with history of recurrent UTI
  4. patients already receiving SGLT2i as part of their treatment
  5. very high blood glucose (A1c more than 11%) or presenting at the clinic with BG above 300 mg/dL.
  6. clinical evidence of dehydration.
  7. Frailty.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm: add-on SGLT2i, beside usual treatment
participants will receive addon SGLT2i, beside continuing their standard of care treatment
Drug: SGLT2 inhibitor
a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Other Names:
  • gliflozins or flozins
No Intervention: Control group: Standard of Care, no add-on treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of adding SGLTi on HbA1c
Time Frame: Six months
Compare the effect on HbA1c between study arms
Six months
comparing CAP change between study arms
Time Frame: Six months
compare steatosis by FibroScan between study arms
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of adding SGLTi on WC
Time Frame: Six months
compare the effect on waist circumference between study arms
Six months
comparing adverse-events between study arms
Time Frame: six months
comparing adverse-events between study arms
six months
compare other metabolic parameters between study arms
Time Frame: six months
compare SBP, DBP, triglycerides, HDL-c, and LDL-c
six months

Collaborators and Investigators

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

Sponsor

Assiut 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

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)

April 1, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGLt2i in type 2 diabetes

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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