NCT01511692已完成1 期
A 4 Week Single Center, Double-dummy, Randomised Double-blind, Balanced Incomplete Latin Square Design Study to Evaluate the Effects of Liraglutide on Appetite in Subjects With Type 2 Diabetes Compared to Glimepiride and Placebo
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
- 43
- 试验地点
- 1
- 主要终点
- The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
研究概览
简要总结
This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effects of liraglutide on energy intake in subjects with type 2 diabetes.
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 65 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 and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy
- •HbA1c for diet-treated subjects: HbA1c between 6.5-10.0% (both inclusive) and for OAD treated subjects: HbA1c between 6.5-9.5% (both inclusive)
- •Body mass index (BMI) between 27-40 kg/m^2 (both inclusive)
- •Subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)
- •Euthyroid subjects
- •Subjects should be unrestrained eaters
排除标准
- •Recurrent severe hypoglycaemia
- •Impaired liver function
- •Impaired renal function
- •Cardiac problems
- •Uncontrolled treated/untreated hypertension
- •Known or suspected allergy to trial products or related products
- •Use of any drug (except for OADs), which in the investigator's opinion could interfere with the subject's glucose level or body weight
- •Active hepatitis B and/or active hepatitis C
- •Positive HIV (human immunodeficiency virus) antibodies
- •Known or suspected abuse of alcohol or narcotics
- •Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the Investigator
研究组 & 干预措施
Lira --> placebo
Experimental
干预措施: liraglutide (Drug)
Lira --> placebo
Experimental
干预措施: placebo (Drug)
Placebo --> glim
Placebo Comparator
干预措施: placebo (Drug)
Placebo --> glim
Placebo Comparator
干预措施: glimepiride (Drug)
Glim --> lira
Active Comparator
干预措施: liraglutide (Drug)
Glim --> lira
Active Comparator
干预措施: glimepiride (Drug)
结局指标
主要结局
The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
次要结局
- The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
- Adverse events
- Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
- Waist circumference
- Total duration of eating at the buffet meal (satiation)
- Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
- Weight
研究者
研究点 (1)
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