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Recruiting NCT07433192

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

— Observational Type 2 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicenter Observational Study POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes in Real-world Clinical Practice.

Overview

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

Detailed description

This single-arm study is planned to include patients who, in routine clinical practice, have been prescribed 2.5 mg of Lusefi® once daily as type 2 diabetes treatment. If the response to the treatment is insufficient, the attending physician in routine clinical practice may increase the daily dose to 5 mg once daily. The total duration of observation within this study will be approximately 6 months.

Describing hypoglycemic effectiveness of luseogliflozin, its effect on the metabolic and hemodynamic parameters in patients with type 2 diabetes in real-world clinical practice.

Primary outcome measures

  • Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin) [Time frame: 6 months]
Secondary outcome measures (9)
  • Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (plasma glucose) [Time frame: 6 months]
  • Effectiveness of luseogliflozin on Body weight [Time frame: 6 months]
  • Effectiveness of luseogliflozin on systolic blood pressure (SBP) [Time frame: 6 months]
  • Effectiveness of luseogliflozin on diastolic blood pressure ( DBP) [Time frame: 6 months]
  • Effectiveness of luseogliflozin on filtration function of the kidneys [Time frame: 6 months]
  • Effectiveness of luseogliflozin on lipid profile (cholesterol ) [Time frame: 6 months]
  • Effectiveness of luseogliflozin on lipid profile (lipoproteins ) [Time frame: 6 months]
  • Effectiveness of luseogliflozin on lipid profile (triglycerides ) [Time frame: 6 months]
  • Effectiveness of luseogliflozin on uric acid level [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Russia · 1 center
  • GBUZ hospital — Anapa

Identifiers

NCT: NCT07433192 · IC4-LUS-004-RUS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗