A Randomised, Multicentre, Open-Label, Parallel-Group, 24-Week Phase IV Study Comparing the Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care: General Practitioner Initiation of Insulin Glargine Versus the Usual Standard of Care
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0%
研究概览
简要总结
The primary objective is to demonstrate the improvement in glycosylated haemoglobin (HbA1c) levels after general practitioner (GP) initiation and management of type 2 diabetes mellitus (T2DM) with insulin glargine compared with their usual clinical practice.
The secondary objective is to demonstrate the importance of GP initiation of insulin glargine for the treatment of T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Usual standard of care
Patients will be treated by their Investigator with the usual standard of care for 24 weeks (e.g., OAD dose titration, addition of a second or third OAD, or referral to an endocrinologist)
干预措施: Oral Anti Diabetics (OAD) (Drug)
General Practitioner initiation with insulin glargine
Patients will be prescribed insulin glargine by their Investigator and they will be taught how to administer insulin glargine according to Australian guidelines. Patients will be treated for 24 weeks.
干预措施: INSULIN GLARGINE (HOE901) (Drug)
结局指标
主要结局
The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0%
时间窗: From week 0 to week 24
次要结局
- Time required to reach the target HbA1c level of < or = 7%(From week 0 to week 24)
- The percentage of patients achieving two consecutive on treatment HbA1c measurements of < or = 7.0%(From week 0 to week 24)
- Decrease in mean HbA1c level(At week 24)
- Decrease in mean Fasting Plasma Glucose (FPG)(At week 24)
- Mean change in body weight(At week 24)