A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIBA Once Daily + NovoRapid® Compared to Insulin Detemir Once Daily + NovoRapid®, All in a Basal-bolus Regimen in Subjects With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Rate of Major and Minor Hypoglycaemic Episodes
研究概览
简要总结
This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 1 diabetes mellitus more than one year
- •Current treatment: basal (once daily at bedtime) - bolus (three times a day just before main meals) regimen only for at least 12 weeks using a long-acting insulin analogue excluding insulin detemir or intermediate-acting insulin as a basal insulin and NovoRapid® as bolus insulin (a brand of basal insulin preparation has not been changed in the preceding 12 weeks)
- •HbA1c below 10.0%
- •Body Mass Index (BMI) below 30.0 kg/m^2
排除标准
- •Known hypoglycaemia unawareness or recurrent major hypoglycaemia
- •Current treatment with total insulin dose of more than 100 U or IU/day
- •Current treatment or expected to start treatment with systemic corticosteroid
研究组 & 干预措施
Insulin Detemir
干预措施: insulin aspart (Drug)
SIBA
干预措施: insulin degludec (Drug)
SIBA
干预措施: insulin aspart (Drug)
Insulin Detemir
干预措施: insulin detemir (Drug)
结局指标
主要结局
Rate of Major and Minor Hypoglycaemic Episodes
时间窗: Week 0 to Week 6 + 5 days follow up
Observed rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
时间窗: Week 0 to Week 6 + 5 days follow up
Observed rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00-05:59 (both inclusive).
次要结局
- Number of Treatment Emergent Adverse Events (AEs)(Week 0 to Week 6 + 5 days follow up)
- Change in Body Weight(Week 0, Week 6)
- Electrocardiogram (ECG)(Week 0, Week 6)
- Diastolic Blood Pressure (BP)(Week 0, Week 6)
- Systolic Blood Pressure (BP)(Week 0, Week 6)