NCT07433192 POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.
| NCT ID | NCT07433192 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Servier Russia |
| Condition | Type 2 Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-03-02 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.
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.
Contact & Investigator
Marina Shestakova
PRINCIPAL INVESTIGATOR
Endocrinology Research Centre
Frequently Asked Questions
Who can join the NCT07433192 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07433192 currently recruiting?
Yes, NCT07433192 is actively recruiting participants. Contact the research team at ekaterina.erina@servier.com for enrollment information.
Where is the NCT07433192 trial being conducted?
This trial is being conducted at Anapa, Russia.
Who is sponsoring the NCT07433192 clinical trial?
NCT07433192 is sponsored by Servier Russia. The principal investigator is Marina Shestakova at Endocrinology Research Centre. The trial plans to enroll 300 participants.
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