EUCTR2012-002839-28-ES进行中（未招募）1 期
A long-term, randomised, double-blind, placebo-controlled, multinational, multi-centre trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes - SUSTAIN? 6 ? Long term outcomes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,297
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Men and women with type 2 diabetes mellitus.
- •- Age higher or equal to 50 years at screening and clinical evidence of cardiovascular disease or age higher or equal to 60 years at screening and subclinical evidence of cardiovascular disease.
- •- Anti-diabetic drug naïve, or treated with one or two OAD(s), or treated with human NPH insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OAD(s).
- •- HbA1c higher or equal to 7.0% at screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1630
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1630
排除标准
- •- Type 1 diabetes mellitus.
- •- Use of GLP-1 receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening.
- •- Use of any DPP-IV inhibitor within 30 days prior to screening.
- •- Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness.
- •- Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening.
- •- History of chronic pancreatitis or idiopathic acute pancreatitis.
- •- An acute coronary or cerebro-vascular event within the previous 14 days from Visit 2.
- •- Currently planned coronary, carotid or peripheral artery revascularisation.
- •- Chronic heart failure NYHA class IV.
- •- Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma.
- •- Personal history of non-familial medullary thyroid carcinoma.
- •- Screening calcitonin higher or equal to 50 ng/L.
研究者
相似试验
招募中
2 期
The effects of cannabidiol (CBD) on psychosocial stress, situational anxiety and nausea experienced in a virtual reality environmentPsychosocial stressSituational anxietyCybersicknessMental Health - AnxietyMental Health - Other mental health disordersMotion sicknessACTRN12623000872639niversity of Sydney74
进行中（未招募）
1 期
Tralokinumab monotherapy for adolescent subjects with moderate-to-severe atopic dermatitis - ECZTRA 6MedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Atopic DermatitisEUCTR2017-005143-33-PLEO Pharma A/S301
进行中（未招募）
1 期
A study of mepolizumab (study medicine) as an add-on therapy in subjects with severe uncontrolled asthmaSubjects with severe asthmaMedDRA version: 17.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2014-002513-27-ESGlaxoSmithKline, S.A.544
进行中（未招募）
不适用
A randomised, double-blind, placebo-controlled, parallel-group, multicenterstudy to demonstrate improvement of symptoms of RLS in subjects withmoderate to severe idiopathic RLS with daytime symptoms who takeoxycodone/naloxone prolonged release (OXN PR) compared to subjects takingplacebo (PLA).Estudio multicéntrico, aleatorizado, con doble anonimato, controlado conplacebo, en grupos paralelos, para demostrar la mejoría de los síntomas delsíndrome de las piernas inquietas (RLS) en pacientes con RLS idiopático, demoderado a grave, con síntomas diurnos, que toman oxicodona/naloxona deliberación prolongada (OXN PR), comparados con el grupo tratado con placebo(PLA).Sindrome de Piernas inquietasRestless Legs SyndromeMedDRA version: 12.0Level: LLTClassification code 10058920Term: Restless legs syndromeEUCTR2009-011107-23-ESMundipharma Research GmbH & Co. KG300
进行中（未招募）
1 期
A study of mepolizumab (study medicine) as an add-on therapy in subjects with severe uncontrolled asthma.Subjects with severe asthmaMedDRA version: 19.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2014-002513-27-EEGlaxoSmithKline Research & Development Ltd544