NCT01517555已完成1 期
A Single Centre, Randomised, Double-blind, Placebo Controlled Trial to Evaluate the Possible Drug-drug Interaction Between Liraglutide and Paracetamol and the Effects of Liraglutide on Postprandial Glucose and Insulin, Gastric Emptying, Appetite Sensations and Energy Intake in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area under the curve of post prandial plasma glucose
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to to investigate if there is a drug-drug interaction between liraglutide and paracetamol (Benuron®) and to investigate the effect of liraglutide on post prandial glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Diet-treated subjects with type 2 diabetes with HbA1c 7.5-9.5 %
- •Subjects with type 2 diabetes in oral anti-diabetic drug (OAD) monotherapy treated with metformin or alpha-glucosidase inhibitors with HbA1c 7.0-9.5%
- •Body mass index (BMI) 18.5-40 kg/m^2
- •Subjects should have a stable body weight for at least 3 months prior to screening (as judged by the Investigator)
排除标准
- •Impaired liver function
- •Impaired renal function
- •Clinically significant active cardiovascular disease including history of myocardial infarction within the last 6 months and/or heart failure
- •Any clinically significant abnormal ECG (electrocardiogram)
- •Uncontrolled treated/untreated hypertension
- •Recurrent severe hypoglycaemia as judged by the Investigator
- •Active hepatitis B and/or active hepatitis C
- •Positive human immunodeficiency virus (HIV) antibodies
- •Known or suspected allergy to trial product(s) or related products
研究组 & 干预措施
Liraglutide
Experimental
干预措施: liraglutide (Drug)
Liraglutide
Experimental
干预措施: placebo (Drug)
Liraglutide
Experimental
干预措施: paracetamol (Drug)
Placebo
Placebo Comparator
干预措施: liraglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
Placebo
Placebo Comparator
干预措施: paracetamol (Drug)
结局指标
主要结局
Area under the curve of post prandial plasma glucose
Area under the curve of paracetamol
次要结局
- Area under the curve of paracetamol
- Cmax, maximum concentration
- Terminal elimination rate constant
- Adverse events
- tmax, time to reach Cmax
- t½, terminal half-life
研究者
研究点 (1)
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