Trial Outcomes & Findings for A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin (NCT NCT01713530)
NCT ID: NCT01713530
Last Updated: 2018-04-02
Results Overview
Change from baseline in HbA1c (%) after 26 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
274 participants
Primary outcome timeframe
Week 0, week 26
Results posted on
2018-04-02
Participant Flow
The trial was conducted in 5 countries (48 sites): Algeria (4), Austria (6), France (8), Norway (6) and United States (24).
Participant milestones
| Measure |
IDegAsp BID
The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
|
IDeg OD+IAsp
The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp (\[NovoRapid®/NovoLog®\], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.
|
|---|---|---|
|
Overall Study
STARTED
|
138
|
136
|
|
Overall Study
Exposed
|
136
|
135
|
|
Overall Study
COMPLETED
|
113
|
117
|
|
Overall Study
NOT COMPLETED
|
25
|
19
|
Reasons for withdrawal
| Measure |
IDegAsp BID
The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
|
IDeg OD+IAsp
The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp (\[NovoRapid®/NovoLog®\], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
5
|
|
Overall Study
Withdrawal criteria
|
21
|
12
|
|
Overall Study
Unclassified
|
4
|
2
|
Baseline Characteristics
A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin
Baseline characteristics by cohort
| Measure |
IDegAsp BID
n=138 Participants
The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
|
IDeg OD+IAsp
n=136 Participants
The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp (\[NovoRapid®/NovoLog®\], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
59.6 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=5 Participants
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.7 • n=7 Participants
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Fasting plasma glucose
|
9.0 mmol/L
STANDARD_DEVIATION 3.0 • n=5 Participants
|
8.8 mmol/L
STANDARD_DEVIATION 2.9 • n=7 Participants
|
8.9 mmol/L
STANDARD_DEVIATION 3.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 26Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation "as randomised".
Change from baseline in HbA1c (%) after 26 weeks of treatment
Outcome measures
| Measure |
IDegAsp BID
n=138 Participants
The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
|
IDeg OD+IAsp
n=136 Participants
The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp (\[NovoRapid®/NovoLog®\], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.
|
|---|---|---|
|
Change From Baseline in HbA1c (%)
|
-1.23 percentage change in HbA1c
Standard Error 0.13
|
-1.42 percentage change in HbA1c
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: The FAS included all randomised subjects (2 subjects-baseline FPG not measured). The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation "as randomised".
Change from baseline in FPG after 26 weeks of treatment
Outcome measures
| Measure |
IDegAsp BID
n=136 Participants
The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
|
IDeg OD+IAsp
n=136 Participants
The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp (\[NovoRapid®/NovoLog®\], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
|
-2.22 mmol/L
Standard Error 0.38
|
-1.90 mmol/L
Standard Error 0.36
|
SECONDARY outcome
Timeframe: During Weeks 0-26Population: The safety Analysis Set (SAS): included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) \<3.1 mmol/L(56 mg/dL))
Outcome measures
| Measure |
IDegAsp BID
n=136 Participants
The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
|
IDeg OD+IAsp
n=135 Participants
The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp (\[NovoRapid®/NovoLog®\], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes
|
706 episodes
|
841 episodes
|
SECONDARY outcome
Timeframe: During Weeks 0-26Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia
Outcome measures
| Measure |
IDegAsp BID
n=136 Participants
The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
|
IDeg OD+IAsp
n=135 Participants
The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp (\[NovoRapid®/NovoLog®\], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes
Probable symptomatic
|
26 episodes
|
33 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes
Documented symptomatic
|
1818 episodes
|
1843 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes
Asymptomatic
|
930 episodes
|
728 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes
Relative
|
91 episodes
|
66 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes
ADA (American Diabetes Association)
|
2894 episodes
|
2685 episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes
Severe
|
29 episodes
|
15 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Outcome measures
| Measure |
IDegAsp BID
n=136 Participants
The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
|
IDeg OD+IAsp
n=135 Participants
The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp (\[NovoRapid®/NovoLog®\], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.
|
|---|---|---|
|
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
|
75 episodes
|
96 episodes
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
A TEAE was 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 |
IDegAsp BID
n=136 Participants
The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
|
IDeg OD+IAsp
n=135 Participants
The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp (\[NovoRapid®/NovoLog®\], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.
|
|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (TEAE)
|
330 number of events
|
298 number of events
|
Adverse Events
IDegAsp BID
Serious events: 7 serious events
Other events: 46 other events
Deaths: 0 deaths
IDeg OD+IAsp
Serious events: 13 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDegAsp BID
n=136 participants at risk
The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
|
IDeg OD+IAsp
n=135 participants at risk
The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp (\[NovoRapid®/NovoLog®\], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.74%
1/136 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/135 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Cardiac disorders
Atrioventricular block complete
|
0.74%
1/136 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/135 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/136 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.74%
1/135 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
General disorders
Chest pain
|
0.74%
1/136 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/135 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.74%
1/136 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/135 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/136 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.74%
1/135 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/136 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
1.5%
2/135 • Number of events 2 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Wrong drug administered
|
0.00%
0/136 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
1.5%
2/135 • Number of events 2 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.74%
1/136 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
1.5%
2/135 • Number of events 2 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/136 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.74%
1/135 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/136 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.74%
1/135 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Nervous system disorders
Hypersomnia
|
0.74%
1/136 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/135 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.74%
1/136 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.74%
1/135 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Psychiatric disorders
Depression
|
0.00%
0/136 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.74%
1/135 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/136 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.74%
1/135 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/136 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.74%
1/135 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/136 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.74%
1/135 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Vascular disorders
Thrombosis
|
0.00%
0/136 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.74%
1/135 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
Other adverse events
| Measure |
IDegAsp BID
n=136 participants at risk
The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
|
IDeg OD+IAsp
n=135 participants at risk
The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp (\[NovoRapid®/NovoLog®\], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.
The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
9/136 • Number of events 9 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
6.7%
9/135 • Number of events 9 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
General disorders
Asthenia
|
7.4%
10/136 • Number of events 10 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
1.5%
2/135 • Number of events 2 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
General disorders
Fatigue
|
5.1%
7/136 • Number of events 7 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
0.74%
1/135 • Number of events 1 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Infections and infestations
Influenza
|
6.6%
9/136 • Number of events 9 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
3.7%
5/135 • Number of events 7 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
11/136 • Number of events 11 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
8.9%
12/135 • Number of events 14 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
5/136 • Number of events 5 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
5.2%
7/135 • Number of events 8 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
8/136 • Number of events 8 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
2.2%
3/135 • Number of events 3 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Nervous system disorders
Headache
|
7.4%
10/136 • Number of events 12 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
5.9%
8/135 • Number of events 12 • The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).
The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated".
|
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