A 6-week Randomised, Double-blind, Parallel-group Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Number of Microscopically Confirmed Episodes of Infusion Set Occlusions
研究概览
简要总结
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII) system in adult subjects with type 1 diabetes.
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
- Double (Participant, Investigator)
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
- •Male or female, age at least 18 years at the time of signing inform consent
- •Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months at the time of screening (Visit 1)
- •Currently treated with insulin aspart, insulin lispro or insulin gluisine for at least 3 months prior to screening (Visit 1)
- •Using an external CSII system for the previous 6 months prior to screening (Visit 1)
- •HbA1c (glycosylated haemoglobin) below or equal to 9.0% as assessed by central laboratory
- •Body Mass Index (BMI) 20.0-35.0 kg/m^2
排除标准
- •History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening (Visit 1)
- •History of abscess at the infusion site within 6 months prior to screening (Visit 1)
- •Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening (Visit 1)
研究组 & 干预措施
FIAsp
The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period
干预措施: Faster-acting insulin aspart (Drug)
Insulin Aspart
The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period
干预措施: insulin aspart (Drug)
结局指标
主要结局
Number of Microscopically Confirmed Episodes of Infusion Set Occlusions
时间窗: During 6 weeks of treatment
The number of microscopically confirmed episodes of infusion set occlusions during 6 weeks of treatment. Episodes of infusion set occlusions were confirmed by microscopic examination of the infusion sets at each routine weekly visit and infusion sets that had been changed prematurely because of leakage, unexplained hyperglycaemia or suspicion of occlusion (observation of a plug).
次要结局
- Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG))(During 6 weeks of treatment)
- Number of Episodes of Possible Infusion Set Occlusions(During 6 weeks of treatment)
- Number of Premature Infusion Set Changes(During 6 weeks of treatment)