Trial Outcomes & Findings for A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus (NCT NCT01835431)
NCT ID: NCT01835431
Last Updated: 2019-06-11
Results Overview
Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
362 participants
Primary outcome timeframe
Week 0 to week 16
Results posted on
2019-06-11
Participant Flow
The trial was conducted at 63 sites in 14 countries as follows: Belgium: 3 sites; Brazil: 1 sites; Canada: 3 sites; Czech Republic 3 sites; Croatia: 2 sites; Israel: 6 sites; Macedonia: 2 sites; Poland: 3 sites; Russia: 5 sites; Serbia: 4 sites; Slovenia: 1 sites; South Africa: 2 sites; Spain: 5 sites; and United States: 23 sites.
Participant milestones
| Measure |
IDegAsp OD
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
182
|
180
|
|
Overall Study
Exposed
|
181
|
179
|
|
Overall Study
COMPLETED
|
174
|
168
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
Reasons for withdrawal
| Measure |
IDegAsp OD
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
other
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
10
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
IDegAsp OD
n=182 Participants
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
n=180 Participants
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
Total
n=362 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.5 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
10.6 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
HbA1c
|
8.1 percentage (%)
STANDARD_DEVIATION 1.2 • n=5 Participants
|
8.1 percentage (%)
STANDARD_DEVIATION 1.2 • n=7 Participants
|
8.1 percentage (%)
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Fasting plasma Glucose (FPG)
|
8.6 mmol/L
STANDARD_DEVIATION 4.4 • n=5 Participants
|
8.1 mmol/L
STANDARD_DEVIATION 4.2 • n=7 Participants
|
8.4 mmol/L
STANDARD_DEVIATION 4.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 to week 16Population: The FAS included all randomised subjects. 20 subjects were withdrawn and only 4 subjects though completed the study did not have assesments.
Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.
Outcome measures
| Measure |
IDegAsp OD
n=173 Participants
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
n=165 Participants
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
|
-0.3 percentage (%)
Standard Deviation 1.0
|
-0.3 percentage (%)
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: week 0, week 16Population: The FAS included all randomised subjects. 338 subjects had assessment at baseline, 326 had assessment at week 16, 2 subjects were withdrawn before exposure and 22 subjects week 16 assessment was not done.
Change from baseline in FPG after 16 weeks of treatment. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.
Outcome measures
| Measure |
IDegAsp OD
n=162 Participants
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
n=148 Participants
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose
|
-0.3 mmol/L
Standard Deviation 6.4
|
-0.1 mmol/L
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: After 16 weeks of treatmentPopulation: The Safety analysis set (SAS) included all subjects receiving at least one dose of the trial product or its comparator
A Treatment Emergent Adverse Event (TEAE) was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day on randomised treatment.
Outcome measures
| Measure |
IDegAsp OD
n=181 Participants
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
n=179 Participants
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (TEAEs)
|
501 number of events
|
460 number of events
|
SECONDARY outcome
Timeframe: After 16 weeks of treatmentPopulation: The SAS included all subjects receiving at least one dose of the trial product or its comparator
Treatment emergent hypoglycaemic episodes (PG \< 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia). Confirmed hypoglycaemic episodes were defined as episodes that were either: 1. Severe (i.e. the child is having altered mental status and cannot assist in their care, is semiconscious or unconscious or in coma with or without convulsions and may require parenteral therapy (glucagon or i.v. glucose), or 2. An episode biochemically confirmed by PG value of \<3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
Outcome measures
| Measure |
IDegAsp OD
n=181 Participants
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
n=179 Participants
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
|---|---|---|
|
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)
|
2532 episodes
|
2672 episodes
|
SECONDARY outcome
Timeframe: After 16 weeks of treatmentPopulation: The SAS included all subjects receiving at least one dose of the trial product or its comparator
The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint
Outcome measures
| Measure |
IDegAsp OD
n=181 Participants
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
n=179 Participants
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
|---|---|---|
|
Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
|
316 episodes
|
291 episodes
|
SECONDARY outcome
Timeframe: After 16 weeks of treatmentPopulation: The SAS included all subjects receiving at least one dose of the trial product or its comparator
The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill.
Outcome measures
| Measure |
IDegAsp OD
n=181 Participants
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
n=179 Participants
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
|---|---|---|
|
Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill
|
599 episodes
|
449 episodes
|
SECONDARY outcome
Timeframe: After 16 weeks of treatmentPopulation: The SAS included all subjects receiving at least one dose of the trial product or its comparator
The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. The ketone meaurement involved an additional finger prick and ketosis was considered present if blood ketones were higher than 1.5mmol/L
Outcome measures
| Measure |
IDegAsp OD
n=181 Participants
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
n=179 Participants
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
|---|---|---|
|
Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L)
|
6 episodes
|
12 episodes
|
Adverse Events
IDegAsp OD
Serious events: 11 serious events
Other events: 96 other events
Deaths: 0 deaths
IDet OD/BID
Serious events: 7 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDegAsp OD
n=181 participants at risk
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
n=179 participants at risk
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/181 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.56%
1/179 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.55%
1/181 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.00%
0/179 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.55%
1/181 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.00%
0/179 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.55%
1/181 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.56%
1/179 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/181 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.56%
1/179 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.8%
5/181 • Number of events 5 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.56%
1/179 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.55%
1/181 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.00%
0/179 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.55%
1/181 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.00%
0/179 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/181 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.56%
1/179 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Congenital, familial and genetic disorders
Developmental glaucoma
|
0.55%
1/181 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.00%
0/179 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Gastrointestinal disorders
Constipation
|
0.55%
1/181 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.00%
0/179 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Gastrointestinal disorders
Gastritis
|
0.55%
1/181 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.00%
0/179 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Infections and infestations
Laryngitis
|
0.00%
0/181 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.56%
1/179 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Infections and infestations
Viral infection
|
0.55%
1/181 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
0.56%
1/179 • Number of events 1 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
Other adverse events
| Measure |
IDegAsp OD
n=181 participants at risk
Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
|
IDet OD/BID
n=179 participants at risk
Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
10/181 • Number of events 13 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
3.9%
7/179 • Number of events 13 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
14/181 • Number of events 22 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
9.5%
17/179 • Number of events 26 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
22/181 • Number of events 25 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
6.7%
12/179 • Number of events 13 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Infections and infestations
Influenza
|
5.0%
9/181 • Number of events 10 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
5.6%
10/179 • Number of events 12 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Infections and infestations
Nasopharyngitis
|
19.9%
36/181 • Number of events 43 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
17.9%
32/179 • Number of events 42 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Infections and infestations
Pharyngitis
|
1.7%
3/181 • Number of events 3 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
5.6%
10/179 • Number of events 13 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
11/181 • Number of events 12 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
9.5%
17/179 • Number of events 18 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Nervous system disorders
Headache
|
12.7%
23/181 • Number of events 47 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
17.9%
32/179 • Number of events 64 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
General disorders
Pyrexia
|
9.4%
17/181 • Number of events 26 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
5.6%
10/179 • Number of events 15 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
7.2%
13/181 • Number of events 16 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
5.0%
9/179 • Number of events 9 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
9/181 • Number of events 13 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
7.3%
13/179 • Number of events 14 • Onset date on or after the first day of esxposure to randomised treatment and no later than 7 days after the last day on randomised treatment
The SAS included all subjects receiving at least one dose of the trial product or its comparator
|
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