NCT02100475已完成3 期
A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification (DUAL™ - Intensification)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c (Glycosylated Haemoglobin)
研究概览
简要总结
This trial is conducted globally. The aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification.
This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin
- •HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of NN9068-3952 trial
排除标准
- •Clinically significant diseases of the major organ systems
- •Screening calcitonin above or equal to 50 ng/L
研究组 & 干预措施
Insulin degludec/liraglutide + Metformin
Experimental
干预措施: insulin degludec/liraglutide (Drug)
Insulin degludec/liraglutide + Insulin Aspart + Metformin
Active Comparator
干预措施: insulin degludec/liraglutide (Drug)
Insulin degludec/liraglutide + Insulin Aspart + Metformin
Active Comparator
干预措施: insulin aspart (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
时间窗: Week 0, week 26
Change from baseline in HbA1c after 26 weeks of treatment.
次要结局
- Change From Baseline in Body Weight(Week 0, week 26)
- Number of Treatment-emergent Confirmed Hypoglycaemic Episodes(Week 0 - 26)
研究者
研究点 (1)
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