| Outcome Measures: |
Primary: Glycosylated Haemoglobin A1c (HbA1c), Measured for the Per Protocol (PP) set, Week 0 and Week 8|Glycosylated Haemoglobin A1c (HbA1c), Measured for the ITT (Intention-to-Treat) set, Week 0 and Week 8 | Secondary: Fructosamine, Week 0 and Week 8|Self-measured Plasma Glucose Profile (Before Breakfast), Week 0 and Week 8|Self-measured Plasma Glucose Profile (After Breakfast), 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|Pharmacokinetics: Cmax of Free Insulin, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Pharmacokinetics: Tmax of Free Insulin, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, 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, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Pharmacokinetics: Cmax of Insulin Detemir, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Pharmacokinetics: Tmax of Insulin Detemir, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, 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, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Pharmacokinetics: Cmax of Insulin Aspart, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Pharmacokinetics: Tmax of Insulin Aspart, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, 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, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart, The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs, Week 0 and Week 8|Weight Z Score, 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, Week 0 and Week 8|Body Mass Index (BMI) Z Score, 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, Week 0 and Week 8|Incidence of Hypoglycaemic Episodes - All Episodes, 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., Weeks 0-8|Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L, 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., Weeks 0-8|Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L, 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., Weeks 0-8|Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face", 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., Week 0 and Week 8|Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face", 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., Week 0 and week 8|Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face", 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., Week 0 and Week 8
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