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临床试验/NCT02670915
NCT02670915已完成3 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

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 834 人开始时间: 2016年5月4日最近更新:
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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
834
试验地点
1
主要终点
Change in the Percentage of HbA1c
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted globally. The aim of the trial is to investigate 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.

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
Double (Participant, Investigator)

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

  • •Male or female, 1 year above or equal to age below 18 years at the time of signing informed consent and below 18 years at the time of randomisation - Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) - Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or Neutral Protamine Hagedorn (NPH) insulin for at least 90 days prior to the screening visit - HbA1c (glycosylated haemoglobin) below or equal 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit

排除标准

  • •More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit - 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

研究组 & 干预措施

Meal-time faster-acting insulin aspart and insulin degludec

Experimental

干预措施: insulin degludec (Drug)

Meal-time faster-acting insulin aspart and insulin degludec

Experimental

干预措施: Faster-acting insulin aspart (Drug)

Meal-time NovoRapid® (insulin aspart) and insulin degludec

Active Comparator

干预措施: insulin aspart (Drug)

Meal-time NovoRapid® (insulin aspart) and insulin degludec

Active Comparator

干预措施: insulin degludec (Drug)

Post-meal faster-acting insulin aspart and insulin degludec

Experimental

干预措施: Faster-acting insulin aspart (Drug)

Post-meal faster-acting insulin aspart and insulin degludec

Experimental

干预措施: insulin degludec (Drug)

结局指标

主要结局

Change in the Percentage of HbA1c

时间窗: Week 0, Week 26

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related participant-site contact and included data collected after a subject discontinued trial product.

次要结局

  • Insulin Dose (Units/kg/Day): Total Bolus(Week 26)
  • Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose(Week 26)
  • Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)(Week 26)
  • Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)(Week 26)
  • Change in 8-point SMPG Profile: PPG Increment Over All Three Meals(Week 0, Week 26)
  • Change in 30-minute PPG(Week 0, Week 26)
  • Change in 8-point SMPG Profile: Mean PPG Over All Three Meals(Week 0, Week 26)
  • Fluctuation in the 8-point SMPG Profile(Week 26)
  • Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG(Week 0, Week 26)
  • Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment(Week 0, Week 26)
  • Change in 1,5-anhydroglucitol(Week 0, Week 26)
  • Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines(Week 26)
  • Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia(Week 26)
  • Insulin Dose (Units/Day): Total Basal(Week 26)
  • Insulin Dose (Units/Day): Total Bolus(Week 26)
  • Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL])(Week 0, Week 26)
  • Change in 8-point SMPG Profile: Mean of the 8-point Profile(Week 0, Week 26)
  • Change in FPG(Week 0, Week 26)
  • Insulin Dose (Units/Day): Individual Meal Insulin Dose(Week 26)
  • Insulin Dose (Units/kg/Day): Total Basal(Week 26)
  • Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included(Week 26)
  • Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal)(Week 0, Week 26)
  • Change in Mean IG Peak After Start of Meal(Week 0, Week 26)
  • Change in 30-minute PPG Increment(Week 0, Week 26)
  • Change in 2-hour PPG(Week 0, Week 26)
  • Change in 2-hour PPG Increment(Week 0, Week 26)
  • Change in AUCIG,0-30min(Week 0, Week 26)
  • Change in AUCIG,0-2h(Week 0, Week 26)
  • Change in AUCIG,0-4h(Week 0, Week 26)
  • Change in Mean Time to the IG Peak After Meal(Week 0, Week 26)
  • Change in 1-hour PPG(Week 0, Week 26)
  • Change in 1-hour PPG Increment(Week 0, Week 26)
  • Change in AUCIG,0-1h(Week 0, Week 26)
  • Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification(Week 0-26)
  • Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification(Week 0-26)
  • Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification(Week 0-26)
  • Change in SD Score of Body Mass Index(Week 0, Week 26)
  • Change in Haematology: Thrombocytes(Week 0, Week 26)
  • Change in AUCIG,0-15min(Week 0, Week 26)
  • Change in Time to the IG Peak After Start of Meal(Week 0, Week 26)
  • Change in IG Peak After Start of Meal(Week 0, Week 26)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total(Week 0-26)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total(Week 0-26)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime(Week 0-26)
  • Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification(Week 0-26)
  • Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification(Week 0-26)
  • Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification(Week 0-26)
  • Number of Treatment Emergent Adverse Events (AEs)(Week 0-26)
  • Change in Vital Sign: Blood Pressure(Week 0, Week 26)
  • Change in Vital Sign: Pulse(Week 0, Week 26)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime(Week 0-26)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)(Week 0-26)
  • Change in Physical Examination(Week 0, Week 26)
  • Change in Body Weight(Week 0, Week 26)
  • Change in Body Mass Index(Week 0, Week 26)
  • Change in Haematology: Haemoglobin(Week 0, Week 26)
  • Change in Biochemistry: Aspartate Aminotransferase (AST)(Week 0, Week 26)
  • Change in Lipid Profile: Total Cholesterol(Week 0, Week 26)
  • Change in Lipid Profile: High Density Lipoproteins (HDL)(Week 0, Week 26)
  • Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)(Week 0-26)
  • Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification(Week 0-26)
  • Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification(Week 0-26)
  • Number of Treatment Emergent Injection Site Reactions(Week 0-26)
  • Change in Height(Week 0, Week 26)
  • Change in SD Score of Body Weight(Week 0, Week 26)
  • Change in Haematology: Haematocrit(Week 0, Week 26)
  • Change in Haematology: Erythrocytes(Week 0, Week 26)
  • Change in Haematology: Leukocytes(Week 0, Week 26)
  • Change in Biochemistry: Creatinine(Week 0, Week 26)
  • Change in Biochemistry: Alanine Aminotransferase (ALT)(Week 0, Week 26)
  • Change in Biochemistry: Alkaline Phosphatase (AP)(Week 0, Week 26)
  • Change in Biochemistry: Sodium(Week 0, Week 26)
  • Change in Biochemistry: Albumin(Week 0, Week 26)
  • Change in Anti-insulin Aspart Antibody Development: Specific(Week 0, Week 26)
  • Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin(Week 0, Week 26)
  • Change in Biochemistry: Potassium(Week 0, Week 26)
  • Change in Biochemistry: Total Bilirubin(Week 0, Week 26)
  • Change in Lipid Profile: Low Density Lipoproteins (LDL)(Week 0, Week 26)
  • Change in Anti-insulin Aspart Antibody Development: Total(Week 0, Week 26)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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