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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 2 diabetes who started luseogliflozin (Lusefi) 7 to 30 days before joining, as part of routine care.
- Age
- 18 years and older
- Sex
- Men and women can join.
- Disease stage
- Type 2 diabetes. Decompensated type 2 diabetes is not allowed.
- Earlier treatment
- Luseogliflozin must have been started 7 to 30 days before the inclusion visit in routine care. HbA1c, eGFR, blood pressure and body weight data dated no later than 15 days from the start of luseogliflozin must exist.
Main reasons for not taking part
- Type 1 diabetes or decompensated type 2 diabetes
- Pregnancy, breastfeeding, or planned pregnancy
- Severe kidney failure (eGFR <30 mL/min/1.73 m2), end-stage chronic kidney disease or dialysis
- Diabetic ketoacidosis, diabetic coma or precoma
- Known allergy to luseogliflozin, or a confirmed or suspected urinary tract infection
Read by machine on 9 November 2026.
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.