EUCTR2011-003148-39-NL进行中（未招募）不适用
A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in children and adolescents 1 to less than 18 years with type 1 Diabetes Mellitus on a basal-bolus regimen with insulin aspart as bolus insulin - BEGIN™: Young 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
- 346
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) Informed consent, and child assent as age-appropriate, obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the child must sign and date the Informed Consent Form according to local requirements. The child, if possible, parents or legal representative of the child must sign and date the Child Assent Form according to local requirements.
- •2) Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines).
- •3) Age: 1 to less than 18 years of age at randomisation
- •4) Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1. No OADs are allowed.
- •5) HbA1c = 11%
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 346
- •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) Known or suspected hypersensitivity to trial product(s) or related products
- •2) Previous participation in this trial. Participation is defined as randomisation
- •3) Girls who are pregnant, breastfeeding or intend to become pregnant
- •4) Girls, who have had menarche and are not using adequate contraceptive measures according to local requirements
- •5) Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator
- •6) More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to
- •7) Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator’s opinion could interfere with the trial
- •8) The receipt of any investigational drug within 1 month prior to Visit 1
研究者
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