About this trial
In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
patients with type 2 diabetes in real-world clinical practice Every investigator is expected to include about 4 patients that meet the inclusion/exclusion criteria. Inclusion period will last up to 6 months.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Hypoglycemic 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
Secondary outcomes
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.
Effectiveness of luseogliflozin on Body weight
Change in Body weight (BW) at Visit 3 compared to baseline.
Effectiveness of luseogliflozin on systolic blood pressure (SBP)
Change in systolic blood pressure (SBP) at Visit 3 compared to baseline
Effectiveness of luseogliflozin on diastolic blood pressure ( DBP)
Change in diastolic blood pressure (DBP) at Visit 3 compared to baseline.
Sponsors and contacts
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