J-DISCOVER: DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,869
- 试验地点
- 1
- 主要终点
- Classes of diabetic medications at baseline and changes up to 3 years
研究概览
简要总结
This study is intended to prospectively research the treatment reality and long-term disease control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line anti-diabetes treatment in sites across Japan.
详细描述
This study is a single country, multicenter, observational, prospective, longitudinal cohort study which will include adult patients with documented history of T2DM who are initiating a second line oral or parenteral anti-diabetes mediation after their first line anti-diabetic therapy in real world setting. The follow-up period is 3 years. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. Patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the study.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent obtained
- •Aged > = 20 years
- •Diagnosed with type 2 diabetes mellitus
- •Initiating a second oral or parenteral anti-diabetic therapy added to oral anti-diabetic monotherapy or switching from the monotherapy to another monotherapy with different drug class
排除标准
- •Diagnosis of Type 1 Diabetes Mellitus
- •Current pregnancy
- •Current treatment for any cancer
- •Current dialysis treatment or renal transplantation
- •Current treatment with any oral steroids
- •Participation in any randomized control trials
- •Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker who does not understand the local language where interpreter are not available, psychiatric disturbances, alcohol or drug abuse).
结局指标
主要结局
Classes of diabetic medications at baseline and changes up to 3 years
时间窗: At 6, 12, 24, 36 month from enrollment
Classes of anti-diabetic medications at baseline and any changes of anti-diabetic medications during 3 years follow-up period.
次要结局
- Hemoglobin A1c change from baseline, Achievement rate of HbA1c and blood glucose target goals(At 6, 12, 24, 36 month from enrollment)
- Blood glucose level change from baseline(At 6, 12, 24, 36 month from enrollment)
- Body weight change from baseline(At 6, 12, 24, 36 month from enrollment)
- Blood pressure change from baseline(At 6, 12, 24, 36 month from enrollment)
- Lipid profile changes from baseline(At 6, 12, 24, 36 month from enrollment)
- Incidence of microvascular complications(At 6, 12, 24, 36 month from enrollment)
- Hypoglycemia events(At 6, 12, 24, 36 month from enrollment)
- Patient reported Quality of Life, diet, and physical activity level(At 6, 12, 24, 36 month from enrollment)
- Initiation of insulin therapy, Proportion of patients using insulin(At 6, 12, 24, 36 month from enrollment)
- Switching of anti-diabetic medications or dose change(At 6, 12, 24, 36 month from enrollment)
- Initiation of third line or above add-on anti-diabetic medications(At 6, 12, 24, 36 month from enrollment)
- Incidence of macrovascular complications(At 6, 12, 24, 36 month from enrollment)
- Risk factors(At 6, 12, 24, 36 month after enrollment)
- Treatment choice(At baseline)