Multicenter Observational Study POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes in Real-world Clinical Practice.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin)
概览
简要总结
In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin)
时间窗: 6 months
Change in glycated hemoglobin (HbA1c) level by the end of the observation period (Visit 3) compared to baseline
次要结局
- Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (plasma glucose)(6 months)
- Effectiveness of luseogliflozin on Body weight(6 months)
- Effectiveness of luseogliflozin on systolic blood pressure (SBP)(6 months)
- Effectiveness of luseogliflozin on diastolic blood pressure ( DBP)(6 months)
- Effectiveness of luseogliflozin on filtration function of the kidneys(6 months)
- Effectiveness of luseogliflozin on lipid profile (cholesterol )(6 months)
- Effectiveness of luseogliflozin on lipid profile (lipoproteins )(6 months)
- Effectiveness of luseogliflozin on lipid profile (triglycerides )(6 months)
- Effectiveness of luseogliflozin on uric acid level(6 months)