Actively Recruiting
POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.
Led by Servier Russia · Updated on 2026-04-30
300
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.
CONDITIONS
Official Title
POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Known hypersensitivity to luseogliflozin or other components of Lusefi4.
- 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.
- 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 45 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
GBUZ hospital
Anapa, Russia
Actively Recruiting
Research Team
E
Ekaterina Erina
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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