NCT00542620已完成4 期
A Randomised, Multicentric, Open Labelled, Parallel Group Trial With Insulin Aspart and Insulin Detemir, Investigating the Glycaemic Effect and Profile in Children With Type 1 Diabetes, of Two Separate Levemir® + NovoRapid® Injections and Extemporaneous Mixing - The Paediatric MIXING Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Glycosylated Haemoglobin A1c (HbA1c)
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily in either separate or mixed injections and to investigate if there is any clinical impact in choosing one regimen over another.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents' Informed Consent (IC) obtained before any trial-related activities
- •Obtained child's assent (when possible)
- •Type 1 diabetes
- •Treatment with insulin detemir and insulin aspart either in extemporaneous mixed or separate injections
- •HbA1c (glycosylated haemoglobin A1c) lesser than or equal to 8.6%
排除标准
- •History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
- •Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
- •Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
- •Any other condition that the Investigator (trial physician) feels would interfere with trial participation or evaluation of results
研究组 & 干预措施
Mixed injection
Experimental
干预措施: insulin aspart (Drug)
Mixed injection
Experimental
干预措施: insulin detemir (Drug)
Separate injection
Active Comparator
干预措施: insulin detemir (Drug)
Separate injection
Active Comparator
干预措施: insulin aspart (Drug)
结局指标
主要结局
Glycosylated Haemoglobin A1c (HbA1c)
时间窗: Week 0 and Week 8
Measured for the ITT (Intention-to-Treat) set
次要结局
- Pharmacokinetics: Cmax of Free Insulin(Week 0 and Week 8)
- Pharmacokinetics: Tmax of Free Insulin(Week 0 and Week 8)
- Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin(Week 0 and Week 8)
- Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin(Week 0 and Week 8)
- Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin(Week 0 and Week 8)
- Pharmacokinetics: Cmax of Insulin Detemir(Week 0 and Week 8)
- Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart(Week 0 and Week 8)
- Weight Z Score(Week 0 and Week 8)
- Body Mass Index (BMI) Z Score(Week 0 and Week 8)
- Incidence of Hypoglycaemic Episodes - All Episodes(Weeks 0-8)
- Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L(Weeks 0-8)
- Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L(Weeks 0-8)
- Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face"(Week 0 and Week 8)
- Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face"(Week 0 and week 8)
- Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face"(Week 0 and Week 8)
- Self-measured Plasma Glucose Profile (Before Breakfast)(Week 0 and Week 8)
- Fructosamine(Week 0 and Week 8)
- Pharmacokinetics: Tmax of Insulin Detemir(Week 0 and Week 8)
- Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir(Week 0 and Week 8)
- Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir(Week 0 and Week 8)
- Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir(Week 0 and Week 8)
- Self-measured Plasma Glucose Profile (After Breakfast)(Week 0 and Week 8)
- Pharmacokinetics: Cmax of Insulin Aspart(Week 0 and Week 8)
- Pharmacokinetics: Tmax of Insulin Aspart(Week 0 and Week 8)
- Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart(Week 0 and Week 8)
- Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart(Week 0 and Week 8)
- Self-measured Plasma Glucose Profile (Before Dinner)(Week 0 and Week 8)
- Self-measured Plasma Glucose Profile (After Dinner)(Week 0 and Week 8)
研究者
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