DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 15,992
- 试验地点
- 1
- 主要终点
- Anti-diabetic treatments prescribed by physicians in a real-world setting.
研究概览
简要总结
DISCOVER is a Non Interventional Study study to describe the disease management patterns and clinical evolution over three years in type 2 diabetes mellitus patients initiating a second line anti-diabetic treatment.
详细描述
DISCOVER is a NIS study to describe the disease management patterns and clinical evolution over three years in type 2 diabetes mellitus patients initiating a second line anti-diabetic treatment. This study is a multi-country, multicenter, observational, prospective, longitudinal cohort study. The patients will be recruitted from countries in Latin America, Europe and Asia pac. It is estimated that approximately 13350 patients will be enrolled in total with each patient followed up for 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Provision of subject informed consent
- •Female or male aged 18 years and over
- •Diagnosed with type 2 diabetes mellitus
- •Initiating a second line anti-diabetic therapy, either as add-on, or switching from one monotherapy to another.
排除标准
- •Diagnosis of type 1 diabetes mellitus
- •Patient is pregnant
- •Patients initiating a dual therapy after having previously received two different lines of monotherapy before (e.g.: Metformin → SU (Sulphonylureas) → SU+Add-on)
- •Current treatment with chemotherapy, oral or iv steroids
- •Patient is on dialysis or has had a renal transplant
- •The patient is taking insulin as first line treatment
- •The patient is taking dual therapy or a fixed dose combination treatment as first line treatment.
- •The patient is taking herbal remedies / natural medicines as first line treatment
- •Participation in an interventional trial
- •Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient for 3 years (e.g. lifethreatening co-morbidities, tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, dementia, alcohol or drug abuse).
- •Not willing to sign the informed consent.
结局指标
主要结局
Anti-diabetic treatments prescribed by physicians in a real-world setting.
时间窗: Up to 3 Years
The drugs (or their combinations) prescribed by physicians to patients initiating a 2nd line anti-diabetic treatment in a real-world setting will be described at inclusion and during 3 years follow-up.
次要结局
- Quality of Life, using Patient Reported Outcomes questionnaires.(Up to 3 years)
- Use of Healthcare resources.(Up to 3 years)
- Disease control in terms of achieving HbA1c target goals and reducing body weight and blood pressure.(Up to 3 years)
- Disease progression (incidence of microvascular and macrovascular complications).(Up to 3 years)
- Changes in anti-diabetic treatments(Up to 3 years)
- Incidence of hypoglycemic events.(Up to 3 years)