In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.
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.
Study Type
OBSERVATIONAL
Enrollment
300
GBUZ hospital
Anapa, Russia
RECRUITINGHypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin)
Change in glycated hemoglobin (HbA1c) level by the end of the observation period (Visit 3) compared to baseline
Time frame: 6 months
Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (plasma glucose)
Change in fasting plasma glucose (FPG) level at Visit 3 compared to baseline.
Time frame: 6 months
Effectiveness of luseogliflozin on Body weight
Change in Body weight (BW) at Visit 3 compared to baseline.
Time frame: 6 months
Effectiveness of luseogliflozin on systolic blood pressure (SBP)
Change in systolic blood pressure (SBP) at Visit 3 compared to baseline
Time frame: 6 months
Effectiveness of luseogliflozin on diastolic blood pressure ( DBP)
Change in diastolic blood pressure (DBP) at Visit 3 compared to baseline.
Time frame: 6 months
Effectiveness of luseogliflozin on filtration function of the kidneys
Change in estimated glomerular filtration rate (eGFR) at Visit 3 compared to baseline.
Time frame: 6 months
Effectiveness of luseogliflozin on lipid profile (cholesterol )
Change in total cholesterol at Visit 3 compared to baseline.
Time frame: 6 months
Effectiveness of luseogliflozin on lipid profile (lipoproteins )
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Change in low-density lipoproteins (LDLP) at Visit 3 compared to baseline.
Time frame: 6 months
Effectiveness of luseogliflozin on lipid profile (triglycerides )
Change in triglycerides (TG) at Visit 3 compared to baseline.
Time frame: 6 months
Effectiveness of luseogliflozin on uric acid level
Change in uric acid level at Visit 3 compared to baseline.
Time frame: 6 months