EUCTR2014-001432-11-DE进行中（未招募）不适用
A double-blinded, randomised, three-period crossover euglycaemic clamp trial investigating the pharmacokinetics, glucodynamics and safety of BC222 human insulin, human insulin (Huminsulin® Normal) and insulin lispro (Humalog®) in subjects with type 1 diabetes
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Adocia
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
- Male
入选标准
- •1.Male subjects with type 1 diabetes mellitus.
- •2. Age between 18 and 64 years, both inclusive.
- •3. Body mass index (BMI) between 18.5 and 28.0 kg BW·m-2, both inclusive.
- •4. HbA1c = 9.0 %.
- •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 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diabetes mellitus type 2.
- •2. Previous participation in this trial. Participation is defined as being randomised.
- •3. The receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial.
- •4. Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator considering the underlying disease.
- •5. History of or presence of cancer (except basal cell skin cancer or squamous cell skin cancer), or any clinically significant cardiovascular (with the exception of treated hypertension), respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), hematological (bleeding disorder), dermatological, venereal, neurological, psychiatric diseases or other major disorders as judged by the Investigator.
- •6. Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
- •7. 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 shows values within the range, the subject can be included in the trial) and/or resting supine heart rate outside the range 50-90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives.
- •8. Clinically significant abnormal ECG at screening, as judged by the Investigator.
- •9. Proliferative retinopathy or maculopathy, as judged by the Investigator based on a recent (< 1.5 years) ophthalmologic examination.
- •10. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the past 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months.
- •11. Clinically significant diabetic neuropathy, in
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