NCT01507285已完成1 期
A Randomised, Double-blind, Placebo-controlled, Dose-escalation, Parallel-group, Single and Multiple Dosing Trial of NN90-1170 in Healthy Volunteers and Patients With Type 2 Diabetes to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
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
- 24
- 试验地点
- 1
- 主要终点
- Area under the Curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after single and multiple doses of NNC 90-1170 (liraglutide) in healthy volunteers and in 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HEALTHY VOLUNTEERS
- •Healthy subjects aged 18-45 years inclusive
- •Healthy subjects are defined as individuals free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and clinical laboratory test results
- •Women who are not of childbearing potential
- •Signed and dated written informed consent obtained
- •Body mass index (BMI) within the range 19-30 kg/m^2, inclusive
- •SUBJECTS WITH DIABETES
- •Subjects aged 40-70 years inclusive
- •Subjects diagnosed with type-2 diabetes and a duration of diabetes of more than 12 months
- •Women who are not of childbearing potential
- •Signed and dated written informed consent obtained
- •Fasting C-peptide at least 0.3 nmol/l and blood glucose at least 7 mmol/l
- •Subjects currently on diet and/or OHA (oral hypoglycemic agents) for at least six months
- •Body mass index (BMI) below 35 kg/m^2
- •HbA1c (glycosylated haemoglobin) below 11%
- •Stable on current medication for at least 3 weeks prior to dosing in this study
排除标准
- •HEALTHY VOLUNTEERS
- •Clinically relevant abnormal history or physical findings (e.g. cancer) at the screening assessment, which could interfere with the objectives of the study or the safety of the subject's participation
- •Clinically relevant abnormalities of laboratory values or ECG at the screening evaluation
- •Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous
- •Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-150 mmHg systolic, 40-90 mmHg diastolic: heart rate 40-100 beats/min
- •History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 28 units weekly in men and more than 21 units weekly in women)
- •Alcohol intake within 48 hours prior to visit
- •Evidence of drug abuse on urine testing at study entry
- •The subject smokes 10 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period
- •Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
- •History of significant drug allergy or drug hypersensitivity
- •SUBJECTS WITH DIABETES
- •Use of any drug (except for oral hypoglycaemic agents (OHAs)) which in the Investigator's opinion could interfere with the blood glucose level (e.g. insulin, systemic corticosteroids, thiazides)
- •Recurrent severe hypoglycaemia as judged by the Investigator
- •Clinically relevant abnormal history or physical findings (e.g. cancer) at the screening assessment, which could interfere with the objectives of the study or the safety of the subject's participation
- •Clinically relevant abnormalities of laboratory values or ECG at the screening evaluation
- •Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous
- •Blood pressure and heart rate in seated position at the screening examination outside the ranges 110-160 mmHg systolic, 60-90 mmHg diastolic: heart rate 40-100 beats/min
- •History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 28 units weekly in men and more than 21 units weekly in women)
- •Alcohol intake within 48 hours of visit
- •Evidence of drug abuse on urine testing at study entry
- •The subject smokes 10 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period
- •Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies
- •History of significant drug allergy or drug hypersensitivity
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
Area under the Curve
次要结局
- t½, terminal half-life
- Cmax, maximum concentration
- tmax, time to maximum concentration
- Adverse events
研究者
研究点 (1)
Loading locations...
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