EUCTR2014-002568-33-CZ进行中（未招募）1 期
Efficacy and Safety of Faster-acting Insulin Aspart compared to NovoRapid® both in Combination with Insulin Degludec in Children and Adolescents with Type 1 Diabetes - onset®7
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
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
- •1. Male or female, 1 = age < 18 years at the time of signing informed consent and < 18 years at the time of randomisation
- •2. Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines)
- •3. Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or NPH insulin for at least 90 days prior to the screening visit
- •4. HbA1c = 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 750
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit
- •2. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
研究者
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