NCT01615978已完成1 期
A Randomised, Double-blind Within Dose Group, Single-centre, Placebo-controlled, Parallel 2-different Dose Group, 14-day Multiple s.c. Doses Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Liraglutide (NNC 90-1170) 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
- 15
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This trial is conducted in Japan. The aim of this trial is to assess the safety after multiple s.c. (subcutaneously) doses of liraglutide in Japanese subjects with type 2 diabetes.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Duration of diabetes for more than 12 weeks
- •Subjects currently on diet therapy (OHA-naïve) or treated with OHA (oral hypoglycaemic agent)
- •monotherapy for more than 12 weeks
- •HbA1c (Glycated haemoglobin A1c) between 6.0-9.0 %, both inclusive
- •Body Mass Index (BMI): 18.5-30.0 kg/m^2
排除标准
- •Recurrent severe hypoglycaemia
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac problems
- •Uncontrolled treated/untreated hypertension
- •Current treatment with insulin preparations or TZDs (thiazolidinediones)
- •Current treatment or expected at the screening to start treatment with systemic corticosteroids
研究组 & 干预措施
Escalated dose: 10 mcg/kg
Experimental
干预措施: placebo (Drug)
Fixed dose: 5 mcg/kg
Experimental
干预措施: liraglutide (Drug)
Fixed dose: 5 mcg/kg
Experimental
干预措施: placebo (Drug)
Escalated dose: 10 mcg/kg
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Adverse events
24-hour profiles of PTH (Parathyroid Hormone)
24-hour profiles of serum calcitonin
24-hour profiles of Ca2+ (ionised calcium)
次要结局
- tmax, time to reach Cmax
- Area under the plasma liraglutide curve
- Cmax, maximum plasma liraglutide concentration
- Terminal phase elimination rate-constant
- t½, terminal elimination half life
- 24-hour profiles of plasma glucose
- 24-hour profiles of serum insulin
研究者
研究点 (1)
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