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Type 2 DiabetesPhase 4NCT06268977

Adding SGLt2 Inhibitors to Patients With Type 2 Diabetes

A Phase 4 study testing SGLT2 inhibitor in people with Type 2 Diabetes, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes. To detect the side-effects of SGLT2i Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
SGLT2 inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
482 participants
Where
1 siteEgypt
Study dates
1 Apr 2025to 30 Jan 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University Hospital

    Asyut

Other trials in Egypt

About this study

Official title: 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
Read the 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.

Conditions
Type 2 Diabetes
Being tested
SGLT2 inhibitor
Keywords
type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGLT2 inhibitorDrug

    Also called gliflozins or flozins

    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.

Study groups in NCT06268977
Study groupRoleWhat they receive
Experimental Arm: add-on SGLT2i, beside usual treatmentExperimentalparticipants will receive addon SGLT2i, beside continuing their standard of care treatment
Receives: Drug: SGLT2 inhibitor
Control group: Standard of Care, no add-on treatmentNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of adding SGLTi on HbA1c

    Compare the effect on HbA1c between study arms

    Measured: Six months

  2. comparing CAP change between study arms

    compare steatosis by FibroScan between study arms

    Measured: Six months

Secondary outcomes (3)

  1. Effect of adding SGLTi on WC

    compare the effect on waist circumference between study arms

    Measured: Six months

  2. comparing adverse-events between study arms

    comparing adverse-events between study arms

    Measured: six months

  3. compare other metabolic parameters between study arms

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

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2024
  2. Study start1 Apr 2025
  3. Primary completion1 Jan 2026
  4. Study completion30 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
non-randomized (quasi-random, sequential) with two steps: First, Clinical Screening foe eligibility. Second, Sequential Allocation (based on the order of cleared medical enrollment: Odd-numbered cleared participants (e.g., 1, 3, 5...) will be allocated to the Experimental Arm and Even-numbered cleared participants (e.g., 2, 4, 6...) will be allocated to the Control Arm.
Masking
None (open label)
Enrolment
482 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06268977
Sponsor's protocol ID
SGLt2i in type 2 diabetes
Status last verified
Sep 2026
First submitted
17 Jan 2024
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6.

    PubMed 34879977

  • Levine MJ. Empagliflozin for Type 2 Diabetes Mellitus: An Overview of Phase 3 Clinical Trials. Curr Diabetes Rev. 2017;13(4):405-423. doi: 10.2174/1573399812666160613113556.

    PubMed 27296042

  • Vukadinovic D, Abdin A, Anker SD, Rosano GMC, Mahfoud F, Packer M, Butler J, Bohm M. Side effects and treatment initiation barriers of sodium-glucose cotransporter 2 inhibitors in heart failure: a systematic review and meta-analysis. Eur J Heart Fail. 2022 Sep;24(9):1625-1632. doi: 10.1002/ejhf.2584. Epub 2022 Jul 8.

    PubMed 35730422

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SGLT2 inhibitor in people with Type 2 Diabetes, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of adding SGLTi on HbA1c (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06268977, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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