Adding SGLt2 Inhibitors to Patients With Type 2 Diabetes

Assiut University

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: SGLT2 inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06268977

SGLt2i in type 2 diabetes

Details and patient eligibility

About

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

- To detect the side-effects of SGLT2i

Full 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.

Enrollment: 482 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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482 participants in 2 patient groups

Experimental Arm: add-on SGLT2i, beside usual treatment

Experimental group

Description:

participants will receive addon SGLT2i, beside continuing their standard of care treatment

Treatment:

Drug: SGLT2 inhibitor

Control group: Standard of Care, no add-on treatment

No Intervention group