Recruiting

POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.

In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.

ClinicalTrials.gov IDNCT07433192
PhaseNot Applicable
Enrollment300
SponsorServier Russia
Age18 Years
SexALL
I'm interested View official listing

Conditions studied

Type 2 Diabetes Mellitus

About this study

In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.

Primary outcomes

Eligibility information

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 locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.