EUCTR2019-001281-14-AT进行中（未招募）1 期
A trial investigating the effect on blood glucose after the injection of fast-acting insulin aspart (Fiasp®) in comparison to insulin aspart (NovoRapid®) around exercise in participants with type 1 diabetes - NN-Ex-Fiasp
Medical University of Graz0 个研究点目标入组 44 人开始时间: 2019年5月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
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
入选标准
- •Adults with type 1 diabetes mellitus (as diagnosed clinically) = 12 months
- •Treated with multiple daily insulin injections = 12 months
- •Body mass index 18.0-29.4 kg/m2 (both inclusive)
- •Mass-specific peak oxygen consumption (VO2peak) >20 ml/kg/min
- •HbA1c = 9.5 % (80 mmol/mol)
- •C-peptide = 0.3 nmol/L
- •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 44
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Receipt of any investigational medicinal product within 1 months prior to screening in this trial
- •Haemoglobin <8.0 mmol/L (male) or < 6.4 mmol/L (female)
- •Systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone and non-routine vitamins and herbal products. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
- •Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influences the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted throughout the run of the trial. Furthermore, it does not excluded patients how have celiac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific (e.g.) gluten-free diet.
- •Participant with a heart rate < 40 beats per minute (bpm) at screening (after resting for 5 min in supine position)
- •Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) 10 at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time
- •Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening Visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on anti-hypertensives
- •Clinically significant abnormal ECG at screening, as judged by the Investigator
- •Severe retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
- •Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise participant’s safety or compliance with the protocol
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- •Significant history of alcoholism or drug/chemical abuse as per Investigator’s judgement or a positive result in the urine drug/alcohol screen at the screening Visit.
- •Smoker (defined as a participant who is smoking more than 5 cigarettes or the equivalent per day)
- •Not able or willing to refrain from smoking, or use of nicotine substitute products during the inpatient period
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the past 12 months)
- •Hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in th
研究者
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