NCT01508949已完成2 期
NNC 90-1170 Mechanism of Action: A Single-centre, Randomised, Double-blind, Parallel-group, Placebo-controlled Trial Evaluating the Effect of NNC 90-1170 on Weight and Appetite in Obese Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in weight
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the effect of NNC 90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated with diet and/or sulphonylurea or repaglinide.
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 mellitus
- •Diet treated and/or subjects in monotherapy with sulphonylurea or repaglinide
- •HbA1c for diet treated subjects 6.5-12%, both inclusive
- •HbA1c for sulphonylurea or repaglinide treated subjects maximum 10%
- •Body mass index (BMI) at least 27 kg/m^2
- •Euthyroid subjects
- •Fasting blood glucose 7-14 mmol/l
排除标准
- •Impaired liver function
- •Impaired renal function
- •Cardiac problems
- •Uncontrolled treated/untreated hypertension
- •Recurrent severe hypoglycaemia as judged by the Investigator
- •Known or suspected allergy to trial product or related products
- •Use of any drug (except for OHAs (oral hypoglycaemic agents), which in the Investigator's opinion could interfere with the glucose level or body weight. Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
研究组 & 干预措施
NNC 90-1170
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 in weight
次要结局
- Energy expenditure
- HbA1c (Glycosylated Haemoglobin)
- Adverse events
- Total fat mass (assessed by use of DEXA (dual energy X-ray absorptiometry) scan)
- Waist circumference
- Spontaneous energy intake assessed in connection to the ad libitum lunch meal
- Appetite assessed in connection with the fixed breakfast meal (assessed by the use of VAS (visual analogue scale))
- Gastric emptying rate
研究者
研究点 (1)
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