Titration Target for Chinese Type 2 Diabetes Mellitus Patients Using Insulin Glargine to Achieve Glycaemic Goals: An Assessment of Three Different Fasting Plasma Glucose Targets - BEYOND III/FPG GOAL Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 947
- 试验地点
- 44
- 主要终点
- Percentage of patients with HbA1c <7% achievement
研究概览
简要总结
Primary Objective:
To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (HbA1c) < 7%.
Secondary Objectives:
The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c <7.0% in patients achieving their FPG target. The percentage of HbA1c <7% without hypoglycemia. The percentage of patients achieving the FPG target without hypoglycemia. The percentage of patients achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast <10 mmol/L).
详细描述
The study duration for each patient will be 27 weeks.
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 65 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
Group 3
Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=7.0 mmol/L
干预措施: INSULIN GLARGINE (Drug)
Group 1
Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=5.6 mmol/L
干预措施: INSULIN GLARGINE (Drug)
Group 2
Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=6.1 mmol/L
干预措施: INSULIN GLARGINE (Drug)
结局指标
主要结局
Percentage of patients with HbA1c <7% achievement
时间窗: 24 weeks
次要结局
- Percentage of patients achieving HbA1c <=6.5%(24 weeks)
- Change from baseline in HbA1c(Baseline to 24 weeks)
- Change in PPG(Baseline to 24 weeks)
- Percentage of patients achieving FPG target with HbA1c <7%(24 weeks)
- Percentage of patients achieving PPG target (2-hour post-breakfast <10 mmol/L)(24 weeks)
- Percentage of patients experienced hypoglycemic events(24 weeks)
- Percentage of patients achieving HbA1c <7% without hypoglycemia(24 weeks)
- Percentage of patients achieving the FPG target without hypoglycemia(24 weeks)
- Percentage of patients achieving FPG target(24 weeks)
- Change in FPG(8 weeks to 24 weeks)
- Change in insulin doses in each arm(1 week to 24 weeks)
- Change in body weight in each treatment arm(Baseline to 24 weeks)