Trial Outcomes & Findings for A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus (NCT NCT01513473)
NCT ID: NCT01513473
Last Updated: 2019-06-13
Results Overview
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
350 participants
Primary outcome timeframe
Week 0, week 26
Results posted on
2019-06-13
Participant Flow
The trial was conducted at 72 sites in 12 countries as follows: Bulgaria (2), Finland (5), France (4), Germany (3), Italy (2), Japan (15), Netherlands (5), Republic of Macedonia (2), Russian Federation (6), South Africa (2), United Kingdom (4), United States (22)
Participant milestones
| Measure |
IDeg + IAsp
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Main Trial (26 Weeks)
STARTED
|
174
|
176
|
|
Main Trial (26 Weeks)
Exposed
|
174
|
175
|
|
Main Trial (26 Weeks)
COMPLETED
|
170
|
165
|
|
Main Trial (26 Weeks)
NOT COMPLETED
|
4
|
11
|
|
Extension Trial (26 Weeks)
STARTED
|
152
|
128
|
|
Extension Trial (26 Weeks)
COMPLETED
|
151
|
122
|
|
Extension Trial (26 Weeks)
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
IDeg + IAsp
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Main Trial (26 Weeks)
Adverse Event
|
0
|
2
|
|
Main Trial (26 Weeks)
Withdrawal by Subject
|
4
|
7
|
|
Main Trial (26 Weeks)
Unclassified
|
0
|
2
|
|
Extension Trial (26 Weeks)
Adverse Event
|
0
|
1
|
|
Extension Trial (26 Weeks)
Withdrawal by Subject
|
1
|
5
|
Baseline Characteristics
A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
IDeg + IAsp
n=174 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=176 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
174 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 26Population: Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Outcome measures
| Measure |
IDeg + IAsp
n=174 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=176 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)
|
-0.20 percentage of glycosylated haemoglobin
Standard Deviation 0.95
|
-0.31 percentage of glycosylated haemoglobin
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.
Change from baseline in HbA1c (%) after 52 weeks of treatments.
Outcome measures
| Measure |
IDeg + IAsp
n=174 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=176 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)
|
-0.27 percentage of glycosylated haemoglobin
Standard Deviation 1.07
|
-0.22 percentage of glycosylated haemoglobin
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks. FPG samples were missing for 9 subjects.
Change from baseline in FPG after 26 weeks of treatment.
Outcome measures
| Measure |
IDeg + IAsp
n=157 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=160 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)
|
-0.67 mmol/L
Standard Deviation 5.99
|
0.50 mmol/L
Standard Deviation 8.37
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks.
Change from baseline in FPG after 52 weeks of treatment.
Outcome measures
| Measure |
IDeg + IAsp
n=157 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=160 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)
|
-1.29 mmol/L
Standard Deviation 6.53
|
1.10 mmol/L
Standard Deviation 8.24
|
SECONDARY outcome
Timeframe: After 26 weeks and 52 weeks of treatmentPopulation: Safety analysis set included all subjects receiving at least one dose of investigational product.
TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Outcome measures
| Measure |
IDeg + IAsp
n=174 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=175 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
TEAEs -26 weeks
|
810 events
|
761 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
TEAEs -52 weeks
|
1462 events
|
1266 events
|
SECONDARY outcome
Timeframe: After 26 weeks and 52 weeks of treatmentPopulation: Safety analysis set included all subjects receiving at least one dose of investigational product.
Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal \[11 p.m. - 7 a.m./23:00 - 07:00\] and over the entire day (24 hours)
Outcome measures
| Measure |
IDeg + IAsp
n=174 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=175 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Number of Hypoglycaemic Episodes
26 weeks (entire day)
|
11712 episodes
|
10991 episodes
|
|
Number of Hypoglycaemic Episodes
26 weeks (nocturnal)
|
1261 episodes
|
1458 episodes
|
|
Number of Hypoglycaemic Episodes
52 weeks (entire day)
|
21560 episodes
|
18373 episodes
|
|
Number of Hypoglycaemic Episodes
52 weeks (nocturnal)
|
2336 episodes
|
2586 episodes
|
SECONDARY outcome
Timeframe: After 26 weeks and 52 weeks of treatmentPopulation: Safety analysis set included all subjects receiving at least one dose of investigational product.
Episodes of PG \>11.1mmol/L (200mg/dL)
Outcome measures
| Measure |
IDeg + IAsp
n=174 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=175 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))
52 weeks
|
58679 episodes
|
52831 episodes
|
|
Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))
26 weeks
|
31264 episodes
|
31173 episodes
|
SECONDARY outcome
Timeframe: After 26 weeks and 52 weeks of treatmentPopulation: Full Analysis Set (FAS) Included all randomised subjects
Blood ketones \> 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment
Outcome measures
| Measure |
IDeg + IAsp
n=174 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=175 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))
26 weeks
|
44 episodes
|
86 episodes
|
|
Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))
52 weeks
|
109 episodes
|
161 episodes
|
SECONDARY outcome
Timeframe: Between week 1 and week 26Population: Full Analysis Set (FAS) Included all randomised subjects. 1 subject was excluded from the analysis in the IDet arm as he was withdrawn before exposure to trial drug.
Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.
Outcome measures
| Measure |
IDeg + IAsp
n=174 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=175 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment
week 12
|
4148.1 pmol/L
Standard Deviation 3726.9
|
5430.1 pmol/L
Standard Deviation 9067.7
|
|
Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment
week 2
|
4540.4 pmol/L
Standard Deviation 3999.0
|
3972.2 pmol/L
Standard Deviation 6721.8
|
|
Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment
week 26
|
4105.6 pmol/L
Standard Deviation 3456.5
|
6377.0 pmol/L
Standard Deviation 10930.6
|
SECONDARY outcome
Timeframe: After 52 weeks of treatmentPopulation: Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.
Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)
Outcome measures
| Measure |
IDeg + IAsp
n=174 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=175 Participants
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)
Insulin aspart specific antibodies
|
1.1 %B/T
Standard Deviation 2.6
|
1.5 %B/T
Standard Deviation 2.3
|
|
Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)
Insulin Detemir specific antibodies
|
NA %B/T
Standard Deviation NA
The antibody analysis was for subjects taking insulin detemir only
|
6.1 %B/T
Standard Deviation 6.5
|
|
Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)
Insulin Degludec specific antibodies
|
0 %B/T
Standard Deviation 0.3
|
NA %B/T
Standard Deviation NA
The antibody analysis was for subjects taking insulin degludec only
|
|
Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)
X-reacting AB Hu Insulin
|
17.2 %B/T
Standard Deviation 7.7
|
26.0 %B/T
Standard Deviation 19.3
|
Adverse Events
IDeg + IAsp
Serious events: 18 serious events
Other events: 146 other events
Deaths: 0 deaths
IDet + IAsp
Serious events: 16 serious events
Other events: 143 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDeg + IAsp
n=174 participants at risk
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=175 participants at risk
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Gastrointestinal disorders
Faecaloma
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.00%
0/175 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/174 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.57%
1/175 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Appendicitis
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
1.1%
2/175 • Number of events 2 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Bronchitis
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.00%
0/175 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Gastroenteritis
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
1.1%
2/175 • Number of events 2 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/174 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
1.1%
2/175 • Number of events 2 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/174 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.57%
1/175 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.00%
0/175 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Urinary tract infection
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.00%
0/175 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.00%
0/175 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.00%
0/175 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Injury, poisoning and procedural complications
Wrong drug administered
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.00%
0/175 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Investigations
Blood ketone body increased
|
0.57%
1/174 • Number of events 2 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
1.1%
2/175 • Number of events 4 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Investigations
Body temperature increased
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.00%
0/175 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/174 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.57%
1/175 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.00%
0/175 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.9%
5/174 • Number of events 7 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
1.1%
2/175 • Number of events 2 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.57%
1/175 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Nervous system disorders
Convulsion
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.00%
0/175 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Nervous system disorders
Headache
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.00%
0/175 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
1.7%
3/175 • Number of events 4 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.57%
1/174 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.57%
1/175 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/174 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.57%
1/175 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/174 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.57%
1/175 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/174 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
0.57%
1/175 • Number of events 1 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
Other adverse events
| Measure |
IDeg + IAsp
n=174 participants at risk
Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
|
IDet + IAsp
n=175 participants at risk
Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
5.7%
10/174 • Number of events 12 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
2.9%
5/175 • Number of events 5 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
12/174 • Number of events 16 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
4.6%
8/175 • Number of events 12 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.1%
28/174 • Number of events 42 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
9.7%
17/175 • Number of events 30 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.6%
22/174 • Number of events 26 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
9.7%
17/175 • Number of events 25 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
13/174 • Number of events 18 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
5.1%
9/175 • Number of events 12 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
14.9%
26/174 • Number of events 38 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
12.6%
22/175 • Number of events 35 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
General disorders
Pyrexia
|
17.2%
30/174 • Number of events 59 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
16.0%
28/175 • Number of events 45 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Bronchitis
|
5.2%
9/174 • Number of events 10 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
4.6%
8/175 • Number of events 11 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Ear infection
|
5.2%
9/174 • Number of events 11 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
6.3%
11/175 • Number of events 11 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Gastroenteritis
|
8.6%
15/174 • Number of events 19 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
12.6%
22/175 • Number of events 25 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Gastroenteritis viral
|
5.7%
10/174 • Number of events 15 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
4.6%
8/175 • Number of events 13 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Influenza
|
9.2%
16/174 • Number of events 19 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
10.3%
18/175 • Number of events 21 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
41.4%
72/174 • Number of events 177 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
38.3%
67/175 • Number of events 141 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Pharyngitis
|
3.4%
6/174 • Number of events 7 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
5.1%
9/175 • Number of events 13 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Rhinitis
|
6.9%
12/174 • Number of events 19 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
8.0%
14/175 • Number of events 23 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Sinusitis
|
5.2%
9/174 • Number of events 13 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
3.4%
6/175 • Number of events 6 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
19.5%
34/174 • Number of events 56 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
13.7%
24/175 • Number of events 58 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Infections and infestations
Viral infection
|
3.4%
6/174 • Number of events 8 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
5.7%
10/175 • Number of events 18 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Investigations
Blood ketone body increased
|
17.8%
31/174 • Number of events 78 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
26.3%
46/175 • Number of events 131 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
14.9%
26/174 • Number of events 62 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
9.7%
17/175 • Number of events 31 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
11/174 • Number of events 16 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
2.9%
5/175 • Number of events 5 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Nervous system disorders
Headache
|
26.4%
46/174 • Number of events 106 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
29.1%
51/175 • Number of events 121 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.8%
31/174 • Number of events 52 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
16.0%
28/175 • Number of events 41 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.5%
13/174 • Number of events 17 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
4.0%
7/175 • Number of events 13 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
29/174 • Number of events 45 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
19.4%
34/175 • Number of events 50 • Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
Safety analysis set included all subjects receiving at least one dose of investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of plans by any investigator to publish and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to Novo Nordisk before submission for comments. Comments will be given within four weeks from receipt of the planned communication.
- Publication restrictions are in place
Restriction type: OTHER