A Comparative Study to Evaluate the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 DM Patients Uncontrolled With a Basal Insulin or Premix Once a Day
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 219
- 试验地点
- 11
- 主要终点
- Changes in Hemoglobin A1c (HbA1c) level
研究概览
简要总结
Primary Objective:
To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen
详细描述
The study duration for each patient is 24 weeks +/- 1 week broken down as follows:
- Run-in phase: 8 weeks
- Follow - up Period: 16 weeks
The maximal possible time window during the study is +/- one week throughout the study.
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
- 21 Years 至 —（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
Arm A: Without Continous Glucose Monitoring (CGM) sensor
Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer .
Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician
干预措施: INSULIN GLARGINE (HOE901) (Drug)
Arm A: Without Continous Glucose Monitoring (CGM) sensor
Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer .
Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician
干预措施: INSULIN GLULISINE (HMR1964) (Drug)
Arm B: Continous Glucose Monitoring (CGM) sensor
Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer .
Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring.
干预措施: INSULIN GLARGINE (HOE901) (Drug)
Arm B: Continous Glucose Monitoring (CGM) sensor
Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer .
Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring.
干预措施: INSULIN GLULISINE (HMR1964) (Drug)
结局指标
主要结局
Changes in Hemoglobin A1c (HbA1c) level
时间窗: Baseline, week 24
次要结局
- Changes in insulin glulisine dose(Baseline, week 24)
- Rate of hypoglycemia(Week 24)
- Changes in insulin glargine dose(Baseline, week 24)