Observational Retrospective Multicenter Study to Evaluate Clinical Outcome Variables Change With dapaGLiflozin Treatment Introduced in Patients With T2D uncOntrolled by the Current Therapy in Real Clinical Practice in RussIA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 929
- 试验地点
- 1
- 主要终点
- HbA1c (glycosylated haemoglobin)
研究概览
简要总结
The study will retrospectively collect clinical variables and socio-demographic data from medical records of patients with T2DM initiating treatment with dapagliflozin after the previous failure/inefficiency of other treatment options (defined as non-achievement of target Hb1Ac) and according to the officially approved indication as per instruction for the use of medicinal product.
It is expected that the best available data regarding clinical variables and patient socio-demographic profiled will be collected from the patient medical records at up to 40 major Russian outpatient clinics/centers specialized in the treatment and management of T2DM patients.
There are 2 time points:
- Baseline data: baseline data are defined as data available within 3 months prior to the first dose of dapagliflozin. In case of presence of multiple data values within baseline period the most recent pre-dose value will be selected
- Follow-up data: any post-baseline data will be considered as follow-up but the primary analysis will be focused on data available at 6 plus/minus 3 months after the initiation of dapagliflozin. In case of discontinuation dapagliflozin, data will be collected at routine visit within 3-month time frame after the last dose
详细描述
Objectives and Hypotheses:
Primary objective:
To describe HbA1c (glycosylated haemoglobin) change from baseline to follow-up
Secondary objectives:
Clinical data:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 Diabetes Mellitus Male and female, age 18-65 years (both inclusive) Patients with T2DM given a first prescription for dapagliflozin after Dec 2014 till 1 October 2016
排除标准
- •Type 1 diabetes Contraindications for SGLT 2 inhibitors (high individual sensitivity to SGLT 2 inhibitors, T1DM, diabetic ketoacidosis, moderate and severe renal failure (eGFR < 60 ml/min/1.73 m3), end-stage renal disease, lactose intolerance, intolerance of glucose and galactose, pregnancy and breast feeding, age younger than 18 years old, use of loop diuretics, decrease of circulating blood volume due to acute disease, age of 77 years old and older Prior use of SGLT 2 inhibitors
结局指标
主要结局
HbA1c (glycosylated haemoglobin)
时间窗: 3 months
To describe HbA1c (glycosylated haemoglobin) change from baseline to follow-up
次要结局
- change of fasting blood glucose(3 months)
- reduction of HbA1c by 0.5% or more(3 months)
- percentage (%) of patients with body weight reduction by at least 5%(3 months)
- change of systolic and diastolic blood pressure(3 months)
- (%) of patients reaching the therapeutic glycemic response (HbA1c <7.0%)(3 months)
- percentage (%) of patients with reduction of HbA1c by 0.5% or more and body weight reduction by at least 5%(3 months)
- change of body weight(3 months)