Type 2 Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Servier Russia
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin) | 6 months | Change in glycated hemoglobin (HbA1c) level by the end of the observation period (Visit 3) compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (plasma glucose) | 6 months | Change in fasting plasma glucose (FPG) level at Visit 3 compared to baseline. |
| Effectiveness of luseogliflozin on Body weight | 6 months | Change in Body weight (BW) at Visit 3 compared to baseline. |
| Effectiveness of luseogliflozin on systolic blood pressure (SBP) | 6 months | Change in systolic blood pressure (SBP) at Visit 3 compared to baseline |
| Effectiveness of luseogliflozin on diastolic blood pressure ( DBP) | 6 months | Change in diastolic blood pressure (DBP) at Visit 3 compared to baseline. |
| Effectiveness of luseogliflozin on filtration function of the kidneys | 6 months | Change in estimated glomerular filtration rate (eGFR) at Visit 3 compared to baseline. |
| Effectiveness of luseogliflozin on lipid profile (cholesterol ) | 6 months | Change in total cholesterol at Visit 3 compared to baseline. |
| Effectiveness of luseogliflozin on lipid profile (lipoproteins ) | 6 months | Change in low-density lipoproteins (LDLP) at Visit 3 compared to baseline. |
| Effectiveness of luseogliflozin on lipid profile (triglycerides ) | 6 months | Change in triglycerides (TG) at Visit 3 compared to baseline. |
| Effectiveness of luseogliflozin on uric acid level | 6 months | Change in uric acid level at Visit 3 compared to baseline. |
Countries
Russia
Contacts
CONTACTEkaterina Erina
PRINCIPAL_INVESTIGATORMarina Shestakova
Endocrinology Research Centre
Outcome results
None listed