| Primary | Glycosylated Haemoglobin A1c (HbA1c) | Measured for the Per Protocol (PP) set | Per Protocol (PP) analysis set consists of all the ITT (Intention-to-Treat) subjects who did not present any significant protocol deviations that could potentially affect the efficacy results. One subject was excluded from PP as subject received separate injections despite being randomised to receive mixed injections. | Posted | | Mean | Standard Deviation | percentage of total haemoglobin | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| | | Title | Denominators | Categories |
|---|
| Week 0 | | | Title | Measurements |
|---|
| - OG0008.00± 0.54
- OG0017.77± 0.55
|
| | Week 8 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | Baseline HbA1c as covariate | 0.001 | If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated | Median Difference (Final Values) | -0.691 | | | | 95 | -1.049 | -0.334 | | | | Yes | Non-Inferiority or Equivalence | Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D>0.25% against HA: D=<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections). |
|
| Primary | Glycosylated Haemoglobin A1c (HbA1c) | Measured for the ITT (Intention-to-Treat) set | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Mean | Standard Deviation | percentage of total haemoglobin | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | Fructosamine | | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | Self-measured Plasma Glucose Profile (Before Breakfast) | | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Mean | Standard Deviation | mg/dL | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | Self-measured Plasma Glucose Profile (After Breakfast) | | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Mean | Standard Deviation | mg/dL | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | Self-measured Plasma Glucose Profile (Before Dinner) | | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Mean | Standard Deviation | mg/dL | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | Self-measured Plasma Glucose Profile (After Dinner) | | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects. | Posted | | Mean | Standard Deviation | mg/dL | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Median | Standard Deviation | pmol/L | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Median | Standard Deviation | hours | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Median | Standard Deviation | pmol.h/L | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects. | Posted | | Median | Standard Deviation | pmol.h/L | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects | Posted | | Median | Standard Deviation | hours | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Median | Standard Deviation | pmol/L | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Median | Standard Deviation | hours | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Median | Standard Deviation | pmol.h/L | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects | Posted | | Median | Standard Deviation | pmol.h/L | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects | Posted | | Median | Standard Deviation | hours | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Median | Standard Deviation | pmol/L | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Median | Standard Deviation | hours | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Median | Standard Deviation | pmol.h/L | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Median | Standard Deviation | pmol.h/L | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Median | Standard Deviation | hours | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Mean | Standard Deviation | Z-score | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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 | Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. | Posted | | Mean | Standard Deviation | Z-score | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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. | All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received. | Posted | | Number | | episodes | | Weeks 0-8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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. | All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received. | Posted | | Number | | episodes | | Weeks 0-8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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. | All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received. | Posted | | Number | | episodes | | Weeks 0-8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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. | All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received. | Posted | | Number | | percentage of subjects | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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. | All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received. | Posted | | Number | | percentage of subjects | | Week 0 and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |
| Secondary | 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. | All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received. | Posted | | Number | | percentage of subjects | | Week 0 and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Mixed Injection | Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed | | OG001 | Separate Injection | Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed |
| |