Treatment of T2DM Patients in Germany Receiving Empagliflozin: A Retrospective RWE Study Description of Treatment and Population Characteristics of Type 2 Diabetic Patients in Germany Receiving Empagliflozin: A Retrospective Real-World Evidence (RWE) Study Based on German Registries DPV&DIVE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,571
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Antidiabetic and Cardiovascular Co-medication
研究概览
简要总结
Description of the real-life treatment of adult patients with type-2 diabetes mellitus (T2DM) receiving Empagliflozin, comparing the characteristics of patients starting Empagliflozin in three time intervals
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11)
- •At least one prescription of an empagliflozin-containing antidiabetic drug: Jardiance® (Empagliflozin, ATC A10BK03, former A10BX12) or Synjardy® (Empagliflozin/ Met¬for¬min, ATC A10BD20)
排除标准
- •Any diagnosis of T1DM
研究组 & 干预措施
Patients receiving Empagliflozin until mid Sep 2015
Patients receiving Empagliflozin before the EMPA-REG-OUTCOME study was published time until mid-Sept. 2015; Cohort 1
干预措施: Empagliflozin (Drug)
Patients receiving Empagliflozin until CV Label Change time
Patients receiving Empagliflozin starting from the EMPA-REG-OUTCOME study being published until CV Label Change time from mid-Sept. 2015-mid-Jan. 2017; Cohort 2
干预措施: Empagliflozin (Drug)
Patients receiving Empagliflozin until last available data cut
Patients receiving Empagliflozin starting from mid-Jan. 2017 until last; Cohort 3
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Percentage of Participants With Antidiabetic and Cardiovascular Co-medication
时间窗: At baseline.
Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants.
Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities
时间窗: At baseline.
Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure.
Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications
时间窗: At baseline.
Percentage of participants with previous occurence of other typical diabetes complications, including, Neuropathy, Nephropathy, Chronic Kidney Disease, Microalbuminuria, Macroalbuminuria, estimated glomerular filtration rate (eGFR), diabetic foot syndrome, retinopathy (background and proliferative).
次要结局
- Percentage of Participants With Previous Glucose-lowering Treatment(At baseline.)
- Percentage of Participants by Age Category(At baseline.)
- Percentage of Male Participants(At baseline.)
- Weight of Participants(At baseline.)
- Height of Participants(At baseline.)
- Glycated Hemoglobin (HbA1c)(At baseline.)
- Duration of Diabetes(At baseline.)
- Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes(At baseline.)
- Number of Participants With Hospitalizations(At baseline.)
- Dosage of Empagliflozin(At baseline.)
- Fasting Plasma Glucose (FPG)(At baseline.)