A Prospective, Observational Registry Study Focusing on the Real World Use, Effectiveness and Safety of Initial Basal Insulin Regimen in Type 2 Diabetic Patients Uncontrolled by Oral Antidiabetic Drugs in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19,894
- 试验地点
- 2
- 主要终点
- To Assess the Change in HbA1c During the 6 Months Follow-up.
研究概览
简要总结
The scientific use of basal insulin is of great help to individuals and the government. However, there are few studies to investigate the real world use, effect, safety and influence factors of basal insulin in China. This study is to evaluate the use of first basal insulin in China patients with type 2 diabetes with inadequate glycemic control on oral antidiabetic agents (OADs) from the naturalistic clinical practice.
详细描述
This is a 6-month multicentre, observational, prospective, registry study. About 200 hospitals from different parts of China will take part in this study, and about 20,000 patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with OADs and willing to accept basal insulin (BI) treatment will be consecutively enrolled during a 12 months period.
The study participants will include at baseline (0 month), 3 month and end point (6 month) to collect the study information. The project will probably last for about 18 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •18-80 years old
- •Type 2 diabetic patients
- •Taking OADs before inclusion
- •Recently tested HbA1c >=7% at the same site within 3 months
- •Being suggested by physician to start basal insulin (BI) treatment
- •Willing to start and having been prescribed BI treatment
- •Willing to join the registry study and sign the informed consent
排除标准
- •Diagnosed with type 1 diabetes
- •Received any type of insulin in the last 2 years (except for the intermittent use of insulin of less than 1 month each time)
- •With any severe health problem, or any other situation judged by the investigator, that is difficult for the 6 months follow-up
- •Current or planned pregnant, lactating women
- •Involved in other clinical trial simultaneously or at most 1 month before
结局指标
主要结局
To Assess the Change in HbA1c During the 6 Months Follow-up.
时间窗: Baseline and 6 months
• Change of HbA1c from baseline to the end-point (6 month).
the Change of Hypoglycemia During Follow-up.
时间窗: baseline and 6 months
•The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)
次要结局
- the FPG Change From Visit 1 to Visit 3(baseline and 6 months)
- the FPG Control Rate at Visit 3(6 months)
- Overall Weight Gain From Visit 1 to Visit 3(baseline and 6 months)