Real-world study of luseogliflozin in adults with type 2 diabetes
Observes how well luseogliflozin works and is tolerated in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.
Key facts
- Where
- Anapa, RussiaSee the site
Where in Russia
- GBUZ hospitalAnapa, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Servier Russia
- Trial code
- NCT07433192
- Record updated
- 30 April 2026
- Original description
In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.Read full original descriptionShow less
Multicenter Observational Study POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes in Real-world Clinical Practice.
In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.
Inclusion: 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: Other concomitant disorders considered by the investigator to affect the natural progression of the disease and significantly impact the treatment results; 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; Known hypersensitivity to luseogliflozin or other components of Lusefi®; Type 1 diabetes; Decompensated type 2 diabetes; Severe infections, pre- and postoperative period, or severe injury; Urinary tract infection (confirmed or suspected); 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; 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; Patients cannot be included in this study if they meet at least one of the following exclusion criteria:; Pregnancy, breastfeeding, or planned pregnancy during the study and at least two months after the study; Diabetic ketoacidosis, diabetic coma or precoma; Predictable unwillingness of the patient to adhere to the treatment regimen and/or cooperate with the investigator.