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

Summary

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

Eligibility

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.

Conditions2

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