Trial Outcomes & Findings for A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (NCT NCT01814137)
NCT ID: NCT01814137
Last Updated: 2017-03-21
Results Overview
Change from baseline in HbA1c after 26 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Week 0, week 26
Results posted on
2017-03-21
Participant Flow
The trial was conducted at 20 sites in 4 countries as follows: Germany: 1 site; Malaysia: 2 sites; Turkey: 1 site; United States: 16 sites. The subjects in this trial were to continue from trial NN5401-3941 (NCT01680341).
Subjects who did not reach the HbA1c target \< 7.0% on IDegAsp BID after 26 weeks of treatment in trial NN5401-3941 were enrolled in this trial.
Participant milestones
| Measure |
IDegAsp BID + IAsp OD
Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
IDeg OD + IAsp TID
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
IDegAsp BID + IAsp OD
Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
IDeg OD + IAsp TID
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Unclassified
|
2
|
1
|
Baseline Characteristics
A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily
Baseline characteristics by cohort
| Measure |
IDegAsp BID + IAsp OD
n=20 Participants
Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
IDeg OD + IAsp TID
n=20 Participants
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
7.9 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.7 • n=5 Participants
|
7.7 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=7 Participants
|
7.8 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Fasting plasma glucose (FPG)
|
7.3 mmol/L
STANDARD_DEVIATION 3.5 • n=5 Participants
|
8.6 mmol/L
STANDARD_DEVIATION 2.8 • n=7 Participants
|
7.9 mmol/L
STANDARD_DEVIATION 3.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 26Population: The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).
Change from baseline in HbA1c after 26 weeks of treatment
Outcome measures
| Measure |
IDegAsp BID + IAsp OD
n=20 Participants
Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
IDeg OD + IAsp TID
n=20 Participants
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
|
0.05 percentage of glycosylated haemoglobin
Standard Error 0.20
|
-0.49 percentage of glycosylated haemoglobin
Standard Error 0.19
|
SECONDARY outcome
Timeframe: During 26 weeks of treatmentPopulation: Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product.
A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product.
Outcome measures
| Measure |
IDegAsp BID + IAsp OD
n=20 Participants
Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
IDeg OD + IAsp TID
n=20 Participants
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (TEAEs)
|
33 number of events
|
45 number of events
|
SECONDARY outcome
Timeframe: During 26 weeks of treatmentPopulation: The SAS included all subjects receiving at least one dose of the investigational product.
Confirmed hypoglycaemic episodes were defined as episodes that are either: * severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or * biochemically confirmed by a PG value of \<3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
Outcome measures
| Measure |
IDegAsp BID + IAsp OD
n=20 Participants
Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
IDeg OD + IAsp TID
n=20 Participants
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes
|
54 episodes
|
95 episodes
|
SECONDARY outcome
Timeframe: During 26 weeks of treatmentPopulation: The SAS included all subjects receiving at least one dose of the investigational product.
Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL).
Outcome measures
| Measure |
IDegAsp BID + IAsp OD
n=20 Participants
Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
IDeg OD + IAsp TID
n=20 Participants
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
|---|---|---|
|
Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes
|
13 episodes
|
12 episodes
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: The FAS included all randomised subjects and missing data was imputed using LOCF. One subject in each arm did not have FPG values from week 0.
Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally.
Outcome measures
| Measure |
IDegAsp BID + IAsp OD
n=19 Participants
Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
IDeg OD + IAsp TID
n=19 Participants
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
|
-0.80 mmol/L
Standard Deviation 3.59
|
-2.57 mmol/L
Standard Deviation 2.73
|
Adverse Events
IDeg OD + IAsp TID
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
IDegAsp BID + IAsp OD
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDeg OD + IAsp TID
n=20 participants at risk
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
IDegAsp BID + IAsp OD
n=20 participants at risk
Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Nervous system disorders
Cerebrovascular accident
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Surgical and medical procedures
Cholecystectomy
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
Other adverse events
| Measure |
IDeg OD + IAsp TID
n=20 participants at risk
Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
IDegAsp BID + IAsp OD
n=20 participants at risk
Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
|
|---|---|---|
|
Eye disorders
Macular oedema
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Eye disorders
Retinal aneurysm
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Eye disorders
Cataract
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
15.0%
3/20 • Number of events 3 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Eye disorders
Eye swelling
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
2/20 • Number of events 3 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 2 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 2 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Gastrointestinal disorders
Lip swelling
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
General disorders
Fatigue
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
10.0%
2/20 • Number of events 2 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
General disorders
Oedema peripheral
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
10.0%
2/20 • Number of events 2 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
General disorders
Pyrexia
|
20.0%
4/20 • Number of events 6 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Immune system disorders
Food allergy
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Eye infection
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Hordeolum
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Otitis media
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Tinea pedis
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
5/20 • Number of events 5 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Injury, poisoning and procedural complications
Wrong drug administered
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Investigations
Blood creatinine increased
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 2 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
0.00%
0/20 • Adverse events were captured on the onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
The SAS included all subjects receiving at least one dose of the investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of any Investigator plans for publication 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 the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
- Publication restrictions are in place
Restriction type: OTHER