POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.

Servier

Status: Enrolling

Conditions: Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT07433192

IC4-LUS-004-RUS

Details and patient eligibility

About

In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.

Full description

This single-arm study is planned to include patients who, in routine clinical practice, have been prescribed 2.5 mg of Lusefi® once daily as type 2 diabetes treatment. If the response to the treatment is insufficient, the attending physician in routine clinical practice may increase the daily dose to 5 mg once daily. The total duration of observation within this study will be approximately 6 months.

Describing hypoglycemic effectiveness of luseogliflozin, its effect on the metabolic and hemodynamic parameters in patients with type 2 diabetes in real-world clinical practice.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.