NCT01664247已完成3 期
The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment 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
- 346
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.
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
- 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 2 diabetes
- •Insulin naïve
- •Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID))
- •Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID)
排除标准
- •Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks
- •Calcitonin equal to or above 50 pg/mL
- •Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks
- •Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)
研究组 & 干预措施
IDeg + Lira
Experimental
干预措施: insulin degludec (Drug)
IDeg + Lira
Experimental
干预措施: liraglutide (Drug)
Placebo + Lira
Experimental
干预措施: placebo (Drug)
Placebo + Lira
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
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 Fasting Plasma Glucose (FPG)(Week 0, week 26)
- Number of Responders for HbA1c (Below 7.0 %)(After 26 weeks of randomised treatment.)
- Change From Baseline in 8-point Profile(Week 0, week 26)
- Change From Baseline in Mean of the 8-point Profile(Week 0, week 26)
- Change From Baseline in Mean Pre-breakfast Measurements Used for Titration(Week 0, week 26)
- Number of Adverse Events(Weeks 0 - 26)
- Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)(Week 0, week 26)
- Number of Hypoglycaemic Episodes(Weeks 0 - 26)
研究者
研究点 (1)
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