EUCTR2010-024049-53-GB进行中（未招募）不适用
Efficacy and Safety of FIAsp compared to insulin aspart both in Combination with insulin detemir in Adults with Type 1 Diabetes - onset® 1
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,095
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
- •Female or male, age 18 years or older at the time of screening (Visit 1)
- •Type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (Visit 1)
- •Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1)
- •Currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (Visit 1)
- •HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
- •Body Mass Index (BMI) equal to or below 35.0 kg/m^2
- •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 602
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 493
排除标准
- •Use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (Visit 1)
- •Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1)
- •Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty
研究者
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