RecruitingRecruiting
POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.
NCT07433192 · Servier Russia
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Multicenter Observational Study POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes in Real-world Clinical Practice.
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 300 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-03-02
Estimated completion: 2027-09-01
Last updated: 2026-04-30
Primary outcomes
- • Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin) (6 months)
Sponsor
Servier Russia · industry
Contacts & investigators
ContactEkaterina Erina · contact · ekaterina.erina@servier.com · +7 495 9370700
InvestigatorMarina Shestakova · principal_investigator, Endocrinology Research Centre
All locations (1)
GBUZ hospitalRecruiting
Anapa, Russia