NCT01513473已完成3 期
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, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN™: Young 1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
- •Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed
- •HbA1c (glycosylated haemoglobin) maximum 11%
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Previous participation in this trial. Participation is defined as randomisation
- •Girls who are pregnant, breastfeeding or intend to become pregnant
- •Girls who have had menarche and are not using adequate contraceptive measures according to local requirements
- •Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator (trial physician)
- •More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1
- •Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator's opinion could interfere with the trial
- •The receipt of any investigational drug within 1 month prior to Visit 1
研究组 & 干预措施
Insulin Degludec + Insulin Aspart
Experimental
干预措施: insulin degludec (Drug)
Insulin Degludec + Insulin Aspart
Experimental
干预措施: insulin aspart (Drug)
Insulin Detemir +Insulin Aspart
Experimental
干预措施: insulin detemir (Drug)
Insulin Detemir +Insulin Aspart
Experimental
干预措施: insulin aspart (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)
时间窗: Week 0, week 26
Change from baseline in HbA1c (%) after 26 weeks of treatment.
次要结局
- Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment(Between week 1 and week 26)
- Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)(Week 0, week 26)
- Number of Treatment Emergent Adverse Events (TEAEs)(After 26 weeks and 52 weeks of treatment)
- Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)(Week 0, week 52)
- Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)(Week 0, week 52)
- Number of Hypoglycaemic Episodes(After 26 weeks and 52 weeks of treatment)
- Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))(After 26 weeks and 52 weeks of treatment)
- Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)(After 52 weeks of treatment)
- Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))(After 26 weeks and 52 weeks of treatment)
研究者
研究点 (1)
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