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OpenTrials
Completed

NCT Number: NCT06268977

Adding SGLt2 Inhibitors to 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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University Hospital

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥18 years)
  • both genders ( male and female)
  • type 2 diabetic patients

Exclusion criteria

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

Treatment and study plan

SGLT2 inhibitor

Drug

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

Primary outcomes

  1. Effect of adding SGLTi on HbA1c

    Time frame: Six months

    Compare the effect on HbA1c between study arms

  2. comparing CAP change between study arms

    Time frame: Six months

    compare steatosis by FibroScan between study arms

Secondary outcomes

  1. Effect of adding SGLTi on WC

    Time frame: Six months

    compare the effect on waist circumference between study arms

  2. comparing adverse-events between study arms

    Time frame: six months

    comparing adverse-events between study arms

  3. compare other metabolic parameters between study arms

    Time frame: six months

    compare SBP, DBP, triglycerides, HDL-c, and LDL-c

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2024
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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