NCT00964964已完成1 期
A Trial Assessing the Number of Hypoglycaemic Episodes and Glycaemic Variability During Two Different Regimens of SIBA 200 U/ml 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
- 18
- 主要终点
- Total number of periods where carbohydrate supplementation is needed during the treatment
研究概览
简要总结
This trial is conducted in Europe. The aim is to compare changes in blood sugar and the number of periods where carbohydrate supplementation is needed to treat low blood sugar, during two different treatments with NN1250 (insulin degludec), a soluble insulin basal analogue (SIBA) 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus for at least 12 months
- •Glycosylated haemoglobin (HbA1c) between 7.5 and 9% (both inclusive)
排除标准
- •Donation or loss of more than 500 ml blood or plasma within three months prior to this trial
- •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) or not able or willing to refrain from smoking and the use of nicotine gum or transdermal nicotine patches during the in-house periods
- •Prior or current treatment with metformin or thiazolidinediones
研究组 & 干预措施
SIBA OD
Experimental
干预措施: insulin degludec (Drug)
SIBA 3W
Experimental
干预措施: placebo (Drug)
SIBA 3W
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Total number of periods where carbohydrate supplementation is needed during the treatment
时间窗: Assessed every day of the two in-house stays of nine days
次要结局
- Frequency of adverse events (AEs)(Assessed every day of the two in-house stays of nine days and one follow-up by telephone)
- Number of periods with low blood sugar during treatment(Assessed every day of the two in-house stays of nine days and one follow-up by telephone)
研究者
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