Multicenter Observational Study POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes in Real-world Clinical Practice.
| Registry | NCT07433192, acronym POLUS |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 300 (Estimated) |
| Sponsor | Servier Russia (Industry) |
| Conditions | Type 2 Diabetes Mellitus |
| Dates | start 2026-03-02, primary completion 2027-03-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-02-25, last updated 2026-04-30 |
| Locations | 1 site in Russia |
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All trials for Type 2 Diabetes Mellitus
In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.
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.
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| GBUZ hospital | Anapa | Russia | Recruiting |