NCT07433192Recruiting
POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.
Multicenter Observational Study POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes in Real-world Clinical Practice.
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 19 Feb 2026
- Start date
- 2 Mar 2026
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Servier Russia
- Diseases
- Type 2 diabetes
- NCT number
- NCT07433192
What you commit to
- Study type: Observational
- Planned participants: 300
- From 2 Mar 2026 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Lab values
- 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.
Age
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GBUZ hospital Coordinator of this site? Confirm its status | Anapa | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.