Evaluation of Insuman Implantable 400 IU/ml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IU/ml
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 479
- 试验地点
- 17
- 主要终点
- Refill accuracy between the 2 insulin groups
研究概览
简要总结
Primary Objective:
To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative phase).
Secondary Objective:
To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman To evaluate daily insulin doses To assess Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases
详细描述
The study duration will be displayed in 2 parts as follow:
Comparative phase (only French patients): 160 +/- 20 days Open label Insuman Implantable extension phase (French and European patients): from day 160 up to the grant of Insuman implantable marketing authorization
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
- Single (Participant)
入排标准
- 年龄范围
- 18 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
Insuman Implantable
Starting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines.
干预措施: HUMAN INSULIN (BIOSYNTHETIC) (Drug)
Insuplant
Starting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines.
干预措施: Insuplant (Drug)
结局指标
主要结局
Refill accuracy between the 2 insulin groups
时间窗: During 4 refill cycles
Change in glycosylated hemoglobin (HbA1c)
时间窗: From baseline to 6 months
次要结局
- Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia(From baseline to 6 months)
- Occurrence of hyperglycaemia(From baseline to 6 months)
- Change in insulin dose(From baseline to 6 months)
- Occurrence of diabetic ketoacidosis(From baseline to 6 months)
- Antibody assessments (anti-Insulin antibodies)(From baseline to 6 months)