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

Recruiting · NCT07433192 · Observational (researchers observe without assigning treatment) · Lead sponsor: Servier Russia

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.

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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

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.

1 location listed.