NCT01682902已完成1 期
A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Mean change in plasma glucose concentration
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of the trial is to evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (Visit 1)
- •Treatment with the same insulin analogue by CSII (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (Visit 1)
- •Using a MiniMed Paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (Visit 1)
- •Glycosylated haemoglobin (HbA1c) below or equal to 9.0% by central laboratory
- •Body Mass Index (BMI) below or equal to 35.0 kg/m^2
排除标准
- •History of diabetic ketoacidsosis (DKA) episodes requiring hospitalization within 6 months prior to the screening visit (Visit 1)
- •History of abscess at the infusion site within 6 months prior to the screening visit (Visit 1)
- •Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the screening visit (Visit 1)
研究组 & 干预措施
Formulation 1
Experimental
干预措施: Faster-acting insulin aspart (Drug)
Formulation 2
Experimental
干预措施: Faster-acting insulin aspart (Drug)
Insulin aspart (NovoLog®)
Active Comparator
干预措施: insulin aspart (Drug)
结局指标
主要结局
Mean change in plasma glucose concentration
时间窗: From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period
次要结局
- Number of hypoglycaemic episodes(Days 0-14 for each treatment period)
- Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG)(Days 0-14 for each treatment period)
- Self-measured plasma glucose (SMPG) 7-point profile(After the first, the second, and the third 14-day treatment period)
- Self-measured plasma glucose (SMPG) 9-point profile(After the first, the second, and the third 14-day treatment period)
- Number of adverse events (AEs) (including infusion site reactions/infections)(Days 0-14 for each treatment periods)
- Number of episodes of infusion set occlusions(Days 0-14 for each treatment period)
研究者
研究点 (1)
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