Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT00542620
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mixed injection insulin detemir - Separate injection insulin detemir - Mixed injection insulin aspart - Separate injection insulin aspart -
- Primary Outcome Measures
Name Time Method Glycosylated Haemoglobin A1c (HbA1c) Week 0 and Week 8 Measured for the ITT (Intention-to-Treat) set
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Cmax of Free Insulin Week 0 and Week 8 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs
Pharmacokinetics: Tmax of Free Insulin Week 0 and Week 8 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
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 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin Week 0 and Week 8 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin Week 0 and Week 8 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Pharmacokinetics: Cmax of Insulin Detemir Week 0 and Week 8 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart Week 0 and Week 8 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Weight Z Score Week 0 and Week 8 Z score of weight. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex
Body Mass Index (BMI) Z Score Week 0 and Week 8 Z score of BMI index. To estimate the growth of children, standardised mean BMI values were calculated for each month of age and for each sex
Incidence of Hypoglycaemic Episodes - All Episodes Weeks 0-8 Number of hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose less than 56 mg/dL (3.1 mmol/L). Classified as major, minor or symptoms only. Major if unable to treat her/himself (given the age of the study population, the definition of major hypoglycemia was to be adapted through the investigator's judgment). Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L Weeks 0-8 Number of minor hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose below 3.1 mmol/L (56 mg/dL) and the child is able to treat her/himself.
Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L Weeks 0-8 Number of "symptoms only" hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose higher than or equal to 3.1 mmol/L (56 mg/dL) or no plasma glucose measurement and the child is able to treat her/himself.
Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face" Week 0 and Week 8 Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.
Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face" Week 0 and week 8 Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.
Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face" Week 0 and Week 8 Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.
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 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
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 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir Week 0 and Week 8 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir Week 0 and Week 8 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Self-measured Plasma Glucose Profile (After Breakfast) Week 0 and Week 8 Pharmacokinetics: Cmax of Insulin Aspart Week 0 and Week 8 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Pharmacokinetics: Tmax of Insulin Aspart Week 0 and Week 8 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
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 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart Week 0 and Week 8 The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Self-measured Plasma Glucose Profile (Before Dinner) Week 0 and Week 8 Self-measured Plasma Glucose Profile (After Dinner) Week 0 and Week 8