Trial Outcomes & Findings for Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial (NCT NCT00542620)
NCT ID: NCT00542620
Last Updated: 2014-11-03
Results Overview
Measured for the Per Protocol (PP) set
COMPLETED
PHASE4
25 participants
Week 0 and Week 8
2014-11-03
Participant Flow
Four centres in France
Children with type 1 diabetes currently treated with insulin detemir and insulin aspart and with a good glycaemic control. At trial entry, subjects must be 6-18 years old with a HbA1c (glycosylated haemoglobin) below or equal to 8.6%
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
Exposed to Drug
|
12
|
13
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial
Baseline characteristics by cohort
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.6 years
STANDARD_DEVIATION 2.6 • n=93 Participants
|
10.9 years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
11.3 years
STANDARD_DEVIATION 2.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
13 participants
n=93 Participants
|
12 participants
n=4 Participants
|
25 participants
n=27 Participants
|
|
Diabetes history
|
6.68 years
STANDARD_DEVIATION 3.51 • n=93 Participants
|
6.13 years
STANDARD_DEVIATION 2.38 • n=4 Participants
|
6.42 years
STANDARD_DEVIATION 2.97 • n=27 Participants
|
PRIMARY outcome
Timeframe: Week 0 and Week 8Population: 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.
Measured for the Per Protocol (PP) set
Outcome measures
| Measure |
Mixed Injection
n=12 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Glycosylated Haemoglobin A1c (HbA1c)
Week 0
|
8.00 percentage of total haemoglobin
Standard Deviation 0.54
|
7.77 percentage of total haemoglobin
Standard Deviation 0.55
|
|
Glycosylated Haemoglobin A1c (HbA1c)
Week 8
|
7.63 percentage of total haemoglobin
Standard Deviation 0.55
|
8.15 percentage of total haemoglobin
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: Week 0 and Week 8Population: 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.
Measured for the ITT (Intention-to-Treat) set
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Glycosylated Haemoglobin A1c (HbA1c)
Week 0
|
7.93 percentage of total haemoglobin
Standard Deviation 0.57
|
7.77 percentage of total haemoglobin
Standard Deviation 0.55
|
|
Glycosylated Haemoglobin A1c (HbA1c)
Week 8
|
7.65 percentage of total haemoglobin
Standard Deviation 0.53
|
8.15 percentage of total haemoglobin
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Fructosamine
Week 0, n=13, 12
|
334.8 mmol/L
Standard Deviation 35.9
|
319.8 mmol/L
Standard Deviation 22.6
|
|
Fructosamine
Week 8, n=12, 12
|
316.4 mmol/L
Standard Deviation 30.1
|
334.8 mmol/L
Standard Deviation 41.9
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Self-measured Plasma Glucose Profile (Before Breakfast)
Week 0
|
190.31 mg/dL
Standard Deviation 56.80
|
165.39 mg/dL
Standard Deviation 70.28
|
|
Self-measured Plasma Glucose Profile (Before Breakfast)
Week 8
|
162.96 mg/dL
Standard Deviation 57.46
|
204.75 mg/dL
Standard Deviation 59.25
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
Outcome measures
| Measure |
Mixed Injection
n=5 Participants
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
|
Separate Injection
n=7 Participants
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
|
|---|---|---|
|
Self-measured Plasma Glucose Profile (After Breakfast)
Week 0, n=5, 6
|
123.00 mg/dL
Standard Deviation 61.9
|
164.89 mg/dL
Standard Deviation 73.33
|
|
Self-measured Plasma Glucose Profile (After Breakfast)
Week 8, n=4, 7
|
208.08 mg/dL
Standard Deviation 48.19
|
167.98 mg/dL
Standard Deviation 70.64
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Self-measured Plasma Glucose Profile (Before Dinner)
Week 0
|
199.14 mg/dL
Standard Deviation 42.05
|
201.44 mg/dL
Standard Deviation 57.50
|
|
Self-measured Plasma Glucose Profile (Before Dinner)
Week 8
|
185.23 mg/dL
Standard Deviation 66.30
|
181.03 mg/dL
Standard Deviation 68.41
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
Outcome measures
| Measure |
Mixed Injection
n=8 Participants
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
|
Separate Injection
n=6 Participants
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
|
|---|---|---|
|
Self-measured Plasma Glucose Profile (After Dinner)
Week 0, n=8, 5
|
175.38 mg/dL
Standard Deviation 58.47
|
201.80 mg/dL
Standard Deviation 59.12
|
|
Self-measured Plasma Glucose Profile (After Dinner)
Week 8, n=7, 6
|
198.00 mg/dL
Standard Deviation 53.85
|
187.67 mg/dL
Standard Deviation 85.63
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Cmax of Free Insulin
Week 0
|
216 pmol/L
Standard Deviation 542.4
|
167 pmol/L
Standard Deviation 130.4
|
|
Pharmacokinetics: Cmax of Free Insulin
Week 8
|
274 pmol/L
Standard Deviation 109.2
|
186 pmol/L
Standard Deviation 105.5
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Tmax of Free Insulin
Week 0
|
2.5 hours
Standard Deviation 0.74
|
3.0 hours
Standard Deviation 0.98
|
|
Pharmacokinetics: Tmax of Free Insulin
Week 8
|
2.5 hours
Standard Deviation 0.8
|
1.8 hours
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin
Week 0
|
638.4 pmol.h/L
Standard Deviation 1022.95
|
398.9 pmol.h/L
Standard Deviation 395.19
|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin
Week 8
|
819.6 pmol.h/L
Standard Deviation 310.41
|
466.2 pmol.h/L
Standard Deviation 266.93
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=11 Participants
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
|
Separate Injection
n=11 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin
Week 0, n=8, 9
|
1441.3 pmol.h/L
Standard Deviation 7516.22
|
752.1 pmol.h/L
Standard Deviation 4128.04
|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin
Week 8, n=11, 11
|
1981.1 pmol.h/L
Standard Deviation 1442.49
|
672.8 pmol.h/L
Standard Deviation 7156.05
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=11 Participants
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
|
Separate Injection
n=11 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin
Week 0, n=8, 9
|
3.6 hours
Standard Deviation 17.84
|
2.3 hours
Standard Deviation 10.93
|
|
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin
Week 8, n=11, 11
|
2.9 hours
Standard Deviation 3.34
|
2.0 hours
Standard Deviation 11.62
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Cmax of Insulin Detemir
Week 8
|
12000 pmol/L
Standard Deviation 23807.2
|
12600 pmol/L
Standard Deviation 8426.6
|
|
Pharmacokinetics: Cmax of Insulin Detemir
Week 0
|
10700 pmol/L
Standard Deviation 25149.9
|
10500 pmol/L
Standard Deviation 6840.2
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Tmax of Insulin Detemir
Week 0
|
3.5 hours
Standard Deviation 0.93
|
3.5 hours
Standard Deviation 0.48
|
|
Pharmacokinetics: Tmax of Insulin Detemir
Week 8
|
3.5 hours
Standard Deviation 0.38
|
3.3 hours
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir
Week 0
|
36591.2 pmol.h/L
Standard Deviation 70709.5
|
34653.4 pmol.h/L
Standard Deviation 21243.3
|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir
Week 8
|
36055.0 pmol.h/L
Standard Deviation 73609.6
|
39757.0 pmol.h/L
Standard Deviation 23076.5
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=4 Participants
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
|
Separate Injection
n=6 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir
Week 8, n=3, 6
|
123555.7 pmol.h/L
Standard Deviation 141207.72
|
362313.5 pmol.h/L
Standard Deviation 4287360.41
|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir
Week 0, n=4, 3
|
230728.2 pmol.h/L
Standard Deviation 304790.62
|
68509.6 pmol.h/L
Standard Deviation 116350.34
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=4 Participants
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
|
Separate Injection
n=6 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir
Week 0, n=4, 3
|
16.2 hours
Standard Deviation 4.12
|
8.2 hours
Standard Deviation 6.53
|
|
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir
Week 8, n=3, 6
|
5.6 hours
Standard Deviation 4.2
|
20.8 hours
Standard Deviation 249.57
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Cmax of Insulin Aspart
Week 0
|
557 pmol/L
Standard Deviation 2784.2
|
762 pmol/L
Standard Deviation 378.3
|
|
Pharmacokinetics: Cmax of Insulin Aspart
Week 8
|
662 pmol/L
Standard Deviation 576.3
|
601 pmol/L
Standard Deviation 355.3
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Tmax of Insulin Aspart
Week 0
|
2 hours
Standard Deviation 0.99
|
2 hours
Standard Deviation 0.97
|
|
Pharmacokinetics: Tmax of Insulin Aspart
Week 8
|
2 hours
Standard Deviation 0.53
|
1.5 hours
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart
Week 8
|
2102.4 pmol.h/L
Standard Deviation 1378.73
|
1540 pmol.h/L
Standard Deviation 894.4
|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart
Week 0
|
1546.3 pmol.h/L
Standard Deviation 3163.27
|
1510.9 pmol.h/L
Standard Deviation 963.37
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart
Week 0, n=10, 11
|
3008.1 pmol.h/L
Standard Deviation 7689.04
|
3006.3 pmol.h/L
Standard Deviation 4458.12
|
|
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart
Week 8, n=13, 12
|
5674.3 pmol.h/L
Standard Deviation 10668.8
|
3019.9 pmol.h/L
Standard Deviation 1013.19
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart
Week 0, n=10, 11
|
2.2 hours
Standard Deviation 6.75
|
2 hours
Standard Deviation 3.09
|
|
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart
Week 8, n=13, 12
|
3.5 hours
Standard Deviation 41.88
|
1.7 hours
Standard Deviation 1.62
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
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
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Weight Z Score
Week 0, n=13, 12
|
-0.42 Z-score
Standard Deviation 0.71
|
0.19 Z-score
Standard Deviation 0.69
|
|
Weight Z Score
Week 8, n=11, 12
|
-0.29 Z-score
Standard Deviation 0.65
|
0.26 Z-score
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
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
Outcome measures
| Measure |
Mixed Injection
n=13 Participants
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
|
Separate Injection
n=12 Participants
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
|
|---|---|---|
|
Body Mass Index (BMI) Z Score
Week 0, n=13, 12
|
-0.32 Z-score
Standard Deviation 0.63
|
0.04 Z-score
Standard Deviation 0.86
|
|
Body Mass Index (BMI) Z Score
Week 8, n=11, 12
|
-0.07 Z-score
Standard Deviation 0.52
|
0.26 Z-score
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Weeks 0-8Population: 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.
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.
Outcome measures
| Measure |
Mixed Injection
n=12 Participants
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
|
Separate Injection
n=13 Participants
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
|
|---|---|---|
|
Incidence of Hypoglycaemic Episodes - All Episodes
|
351 episodes
|
293 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-8Population: 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.
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.
Outcome measures
| Measure |
Mixed Injection
n=12 Participants
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
|
Separate Injection
n=13 Participants
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
|
|---|---|---|
|
Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L
With symptoms
|
68 episodes
|
159 episodes
|
|
Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L
Without (w/o) symptoms
|
75 episodes
|
48 episodes
|
|
Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L
W/o info on presence of symptoms
|
23 episodes
|
6 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-8Population: 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.
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.
Outcome measures
| Measure |
Mixed Injection
n=12 Participants
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
|
Separate Injection
n=13 Participants
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
|
|---|---|---|
|
Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L
W/o information on presence of symptoms
|
5 episodes
|
1 episodes
|
|
Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L
With symptoms
|
49 episodes
|
46 episodes
|
|
Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L
Without (w/o) symptoms
|
131 episodes
|
33 episodes
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
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.
Outcome measures
| Measure |
Mixed Injection
n=12 Participants
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
|
Separate Injection
n=13 Participants
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
|
|---|---|---|
|
Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face"
Week 0
|
45 percentage of subjects
|
33 percentage of subjects
|
|
Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face"
Week 8
|
0 percentage of subjects
|
23 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 0 and week 8Population: 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.
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.
Outcome measures
| Measure |
Mixed Injection
n=12 Participants
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
|
Separate Injection
n=13 Participants
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
|
|---|---|---|
|
Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face"
Week 8
|
81 percentage of subjects
|
69 percentage of subjects
|
|
Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face"
Week 0
|
27 percentage of subjects
|
50 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 0 and Week 8Population: 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.
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.
Outcome measures
| Measure |
Mixed Injection
n=12 Participants
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
|
Separate Injection
n=13 Participants
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
|
|---|---|---|
|
Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face"
Week 0
|
27.3 percentage of subjects
|
16.7 percentage of subjects
|
|
Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face"
Week 8
|
18.2 percentage of subjects
|
7.7 percentage of subjects
|
Adverse Events
Mixed Injection
Separate Injection
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mixed Injection
n=12 participants at risk
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
|
Separate Injection
n=13 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Rhinitis
|
8.3%
1/12 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
15.4%
2/13 • Number of events 2 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
7.7%
1/13 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
0.00%
0/13 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/12 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
7.7%
1/13 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
7.7%
1/13 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Infections and infestations
Viral infection
|
8.3%
1/12 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
0.00%
0/13 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
23.1%
3/13 • Number of events 3 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
General disorders
Injection site reaction
|
0.00%
0/12 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
7.7%
1/13 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
7.7%
1/13 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Surgical and medical procedures
Orthodontic procedure
|
0.00%
0/12 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
7.7%
1/13 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Surgical and medical procedures
Tooth extraction
|
8.3%
1/12 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
0.00%
0/13 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Eye disorders
Conjunctivitis allergic
|
8.3%
1/12 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
0.00%
0/13 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
7.7%
1/13 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/12 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
7.7%
1/13 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
7.7%
1/13 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.3%
1/12 • Number of events 1 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
0.00%
0/13 • Adverse events are collected during treatment period (8 weeks)
All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Steering Committee has the right to publish the entire results of the trial. Any such scientific paper, presentation, communication, or other information concerning the investigation must be approved by the Steering Committee, and copies submitted in writing to Novo Nordisk prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
- Publication restrictions are in place
Restriction type: OTHER