NCT01557166已完成3 期
Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea. A 32 Week Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre and Multinational Trial
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
- 359
- 试验地点
- 1
- 主要终点
- Change From Baseline in Apnoea-hypopnoea Index (AHI)
研究概览
简要总结
This trial is conducted in North America. The aim of the trial is to investigate the effect of liraglutide in obese subjects with sleep apnoea.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Body mass index equal to or above 30 kg/m^2
- •Stable body weight (less than 5% self-reported change during the previous 3 months)
- •Diagnosis of moderate or severe obstructive sleep apnoea (OSA)
- •Unwilling or unable to use continuous positive airway pressure (CPAP) (or other positive airway pressure) treatment. No CPAP (or other positive airway pressure) treatment for at least four weeks prior to screening
- •Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, compliance to visit schedule and dietary advice and complete trial related questionnaires
排除标准
- •Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 inhibitors or insulin within the last 3 months prior to screening
- •Diagnosis of type 1 or type 2 diabetes per judgement of the investigator
- •Glycosylated haemoglobin (HbA1c) equal to or above 6.5%
- •Significant craniofacial abnormalities that may cause OSA
- •Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator
- •Use of central stimulants, hypnotics, mirtazepine, opioids, trazodone within the previous 3 months prior to screening
- •Obesity induced by drug treatment
- •Treatment with pramlintide, sibutramine, orlistat, zonisamide, topiramate or phenteremine within the last 3 month prior to screening
- •Previous surgical treatment for obesity
- •Screening calcitonin equal to or above 50 ng/L
- •Familial or personal history of Multiple Endocrine Neoplasia type 2 or familial Medullary Thyroid Carcinoma
- •Personal history of non-familial Medullary Thyroid Carcinoma
- •History of chronic pancreatitis or idiopathic acute pancreatitis
- •History of Major Depressive Disorder or suicide attempts
- •Systolic blood pressure equal to or above 160 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
研究组 & 干预措施
Liraglutide 3.0 mg
Experimental
干预措施: liraglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Apnoea-hypopnoea Index (AHI)
时间窗: Week 0, Week 32
Observed mean change from baseline in AHI (events/hour) after 32 weeks of treatment. AHI (apnoea and hypopnoea events per hour of sleep) is a measure used for the diagnosis and severity classification of obstructive sleep apnoea. AHI severity category: none ≤4.9; mild 5.0-14.9; moderate 15.0-29.9; severe ≥30.0 events/hour.
次要结局
- Change From Baseline in Fasting Plasma Glucose(Week 0, week 32)
- Change From Baseline in Body Weight (kg)(Week 0, week 32)
- Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)(Week 0, week 32)
研究者
研究点 (1)
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