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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Effectiveness of luseogliflozin on Body weight |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ekaterina Erina | Contact | +7 495 9370700 | ekaterina.erina@servier.com |
| Name | Affiliation | Role |
|---|---|---|
| Marina Shestakova | Endocrinology Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GBUZ hospital | Recruiting | Anapa | Russia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Change in Body weight (BW) at Visit 3 compared to baseline.
| 6 months |
| Effectiveness of luseogliflozin on systolic blood pressure (SBP) | Change in systolic blood pressure (SBP) at Visit 3 compared to baseline | 6 months |
| Effectiveness of luseogliflozin on diastolic blood pressure ( DBP) | Change in diastolic blood pressure (DBP) at Visit 3 compared to baseline. | 6 months |
| Effectiveness of luseogliflozin on filtration function of the kidneys | Change in estimated glomerular filtration rate (eGFR) at Visit 3 compared to baseline. | 6 months |
| Effectiveness of luseogliflozin on lipid profile (cholesterol ) | Change in total cholesterol at Visit 3 compared to baseline. | 6 months |
| Effectiveness of luseogliflozin on lipid profile (lipoproteins ) | Change in low-density lipoproteins (LDLP) at Visit 3 compared to baseline. | 6 months |
| Effectiveness of luseogliflozin on lipid profile (triglycerides ) | Change in triglycerides (TG) at Visit 3 compared to baseline. | 6 months |
| Effectiveness of luseogliflozin on uric acid level | Change in uric acid level at Visit 3 compared to baseline. | 6 months |
| D004700 | Endocrine System Diseases |