A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIAC Compared to Mix30 (NovoRapid®30Mix) on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 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/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 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 2 diabetes mellitus
- •Current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks)
- •HbA1c below 10.0%
- •Body Mass Index (BMI) < 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
- •Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor and insulin sensitizer [thiazolidinedione: TZD]) within the last 12 weeks prior to screening
研究组 & 干预措施
Mix30
干预措施: biphasic insulin aspart 30 (Drug)
SIAC
干预措施: insulin degludec/insulin aspart (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
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
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 and 05:59 (both inclusive).
次要结局
- Diastolic BP (Blood Pressure)(Week 0, Week 6)
- Number of Treatment Emergent Adverse Events (AEs)(Week 0 to Week 6 + 5 days follow up)
- Change in Body Weight(Week 0, Week 6)
- Systolic BP (Blood Pressure)(Week 0, Week 6.)
- Electrocardiogram (ECG) Worsening(Week 0, Week 6)