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

Exclusion Criteria12

• 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.