Luseogliflozin (Lusefi) use in adults with type 2 diabetes

Multicenter Observational Study POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes in Real-world Clinical Practice.

This non-interventional project will try Lusefi (luseogliflozin) in adults with type 2 diabetes to see how well it lowers blood sugar and how well patients tolerate it during routine care.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Servier Russia (industry)
• Locations: 1 site (Anapa)
• Trial ID: NCT07433192 on ClinicalTrials.gov

What this trial studies

This is a single-arm, non-interventional observational project enrolling adults with type 2 diabetes who were started on Lusefi 2.5 mg once daily in routine practice. Patients who have an insufficient response may have their dose increased to 5 mg once daily at the treating physician's discretion. Key measures include HbA1c, estimated glomerular filtration rate (eGFR), blood pressure, body weight, and other metabolic and hemodynamic parameters collected over approximately six months. All data are collected during routine clinic visits to describe real-world effectiveness and tolerability.

Who should consider this trial

Good fit: Adults (≥18) with type 2 diabetes who started Lusefi 2.5 mg once daily 7–30 days before enrollment, have recent baseline data (HbA1c, eGFR, BP, weight), and can give informed consent are ideal candidates.

Not a fit: People with type 1 diabetes, decompensated diabetes, severe renal failure (eGFR <30 mL/min/1.73 m2), pregnancy or breastfeeding, or known allergy to luseogliflozin are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the findings could give doctors real-world information on blood sugar control, weight, blood pressure, kidney function, and side effects with Lusefi to guide treatment decisions.

How similar studies have performed: Other randomized trials and real-world evaluations of SGLT2 inhibitors, including prior studies of luseogliflozin, have shown improvements in HbA1c, weight, and some cardiovascular/renal markers, so this approach aligns with existing evidence.

Eligibility criteria

Inclusion Criteria:

* Men and women aged 18 years and older.
* Patients with type 2 diabetes.
* Written informed consent of the patient to participate in the study.
* No conditions that require emergency medical aid.
* Treatment with luseogliflozin started 7 to 30 days prior to the inclusion visit as part of routine clinical practice and in accordance with the SmPC approved in the Russian Federation.
* Presence of data on the parameters of interest (HbA1c, eGFR, BP, body weight), dated no later than 15 days from the date the treatment with luseogliflozin was started

Exclusion Criteria:

* Patients cannot be included in this study if they meet at least one of the following exclusion criteria:
* Known hypersensitivity to luseogliflozin or other components of Lusefi®.
* Type 1 diabetes.
* Decompensated type 2 diabetes.
* Pregnancy, breastfeeding, or planned pregnancy during the study and at least two months after the study.
* Severe renal failure (eGFR \<30 mL/min/1.73 m2), end-stage chronic kidney disease (CKD) or dialysis, as the treatment is predicted to be ineffective in this population of patients.
* Diabetic ketoacidosis, diabetic coma or precoma.
* Severe infections, pre- and postoperative period, or severe injury.
* Any suspected or confirmed malignant neoplasm, including a history of malignancy within ≤5 years prior to screening, excluding successfully treated basal cell carcinoma and squamous cell carcinoma of the skin or in situ cervical cancer.
* Urinary tract infection (confirmed or suspected).
* Other concomitant disorders considered by the investigator to affect the natural progression of the disease and significantly impact the treatment results.
* Predictable unwillingness of the patient to adhere to the treatment regimen and/or cooperate with the investigator.
* Participation of the patient in another clinical study within 3 months (6 months for biological medicinal products) prior to the inclusion visit or during this study.

Where this trial is running

Anapa

• GBUZ hospital — Anapa, Russia (RECRUITING)

Study contacts

• Principal investigator: Marina Shestakova — Endocrinology Research Centre
• Study coordinator: Ekaterina Erina

Conditions: Type 2 Diabetes Mellitus