NCT01686945已完成1 期
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male 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
- 107
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAEs) recorded
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male subjects with type 2 diabetes (T2D).
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 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator. This also applies to subjects with T2D, except for the underlying diabetes with or without associated hyperlipidaemia and/or hypertension
- •Body mass index (BMI): a) Healthy subjects: above or equal to 20 and below 30 kg/m^
- •b) Subjects with T2D: BMI above or equal to 20 and below or equal to 37 kg/m^2
- •Glycosylated haemoglobin (HbA1c): a) Healthy subjects: below 6.0%. b) Subjects with T2D: between 6.5 and 9.0% (both inclusive)
- •Additional inclusion criterion only for subjects with T2D: Male subjects with T2D (diagnosed within the past 10 years) treated with diet and exercise and/or who have been on stable doses of metformin for at least 12 weeks prior to Visit 3 (Day -1 or 0) and for whom no changes in treatment are planned for the trial period
排除标准
- •History of, or presence of, cancer, diabetes (only for healthy subjects) or any clinically significant cardiovascular (only for healthy subjects), respiratory, metabolic, renal, hepatic, gastro-intestinal (GI), endocrinological (except diabetes in subjects with T2D), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- •Blood pressure in supine position at the screening examination above: a) 140 mmHg systolic and/or above 90 mmHg diastolic for healthy subjects. b) 160 mmHg systolic and/or above 95 mmHg diastolic for subjects with T2D
- •Use of prescription or non-prescription medicinal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted. a. For subjects with T2D: Any other current diabetes treatment apart from metformin (e.g. treatment with incretin mimetics, Dipeptidyl Peptidase-IV (DPP-IV) inhibitors, insulin secretagogues, insulin or thiazolidinediones (TZDs)). Use of blood lipidregulating agents, as well as blood pressure regulating, and thrombo-embolic agents is allowed
- •Exclusion criteria only for subjects with T2D:
- •Proliferative retinopathy or maculopathy requiring acute treatment as determined by funduscopy/fundus photography and judged by the investigator. If subject presents a medical certificate for funduscopy/fundus photography performed within last 3 months this can substitute the funduscopy/fundus photography at screening
- •Nephropathy stages 3 to 5, i.e. estimated glomerular filtration rate (eGFR) below
- •The eGFRshould be determined using the Modification of Diet in Renal Disease 4-variable method encompassing creatinine, age, gender, and race
- •Diabetic peripheral neuropathy using the 10 g Semmes-Weinstein monofilament examination at the great toe or plantar aspect of the fifth metatarsal
- •Clinically significant active cardiovascular disease including history of myocardial infarction and/or heart failure (New York Heart Association (NYHA) class III and IV1) at the discretion of the investigator
研究组 & 干预措施
Healthy - 20 mg
Experimental
干预措施: semaglutide (Drug)
Healthy - 20 mg
Experimental
干预措施: placebo (Drug)
Healthy - 40 mg
Experimental
干预措施: semaglutide (Drug)
Healthy - 40 mg
Experimental
干预措施: placebo (Drug)
Healthy - 60 mg
Experimental
干预措施: semaglutide (Drug)
Healthy - 60 mg
Experimental
干预措施: placebo (Drug)
T2D - 20/40/60 mg
Experimental
干预措施: semaglutide (Drug)
T2D - 20/40/60 mg
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs) recorded
时间窗: From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104)
次要结局
- Change from baseline in glucagon(Week 0, week 10 (Day 69))
- Area under the plasma concentration curve over the dosing interval (0-24 hours)(After the last 3 daily doses for semaglutide and carrier)
- Change from baseline in fasting plasma glucose (FPG)(Week 0, week 10 (Day 69))
- Change from baseline in C-peptide(Week 0, week 10 (Day 69))
- Change from baseline in glycosylated haemoglobin type A1c (HbA1c)(Week 0, week 10 (Day 69))
- Change from baseline in insulin(Week 0, week 10 (Day 69))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male SubjectsHealthyDiabetesDiabetes Mellitus, Type 2NCT01272973Novo Nordisk A/S96
已完成
1 期
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male SubjectsHealthyDiabetesNCT01967589Novo Nordisk A/S82
已完成
1 期
Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy SubjectsHealthyDiabetesNCT01978613Novo Nordisk A/S100
已完成
1 期
Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male SubjectsHealthyDiabetesDiabetes Mellitus, Type 2NCT01866748Novo Nordisk A/S170
已完成
1 期
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male SubjectsHealthyDiabetesDiabetes Mellitus, Type 2NCT01690169Novo Nordisk A/S45