Trial Outcomes & Findings for Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes (NCT NCT00612040)
NCT ID: NCT00612040
Last Updated: 2017-03-03
Results Overview
Change from baseline in HbA1c after 16 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
178 participants
Primary outcome timeframe
Week 0, Week 16
Results posted on
2017-03-03
Participant Flow
A total of 28 centres participated: Australia (5), Germany (6), Norway (6), Sweden (5) and United States (6).
Participant milestones
| Measure |
SIBA (D)
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
59
|
59
|
|
Overall Study
Exposed
|
60
|
59
|
59
|
|
Overall Study
COMPLETED
|
55
|
52
|
52
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
7
|
Reasons for withdrawal
| Measure |
SIBA (D)
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
0
|
|
Overall Study
Unclassified
|
2
|
2
|
5
|
Baseline Characteristics
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Gender
Female
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Gender
Male
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.5 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.0 • n=5 Participants
|
8.4 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=7 Participants
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.8 • n=5 Participants
|
8.4 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=4 Participants
|
|
Fasting plasma glucose (FPG)
|
10.3 mmol/L
STANDARD_DEVIATION 4.8 • n=5 Participants
|
9.9 mmol/L
STANDARD_DEVIATION 3.3 • n=7 Participants
|
9.5 mmol/L
STANDARD_DEVIATION 3.8 • n=5 Participants
|
9.9 mmol/L
STANDARD_DEVIATION 4.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 16Population: The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).
Change from baseline in HbA1c after 16 weeks of treatment
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-0.54 percentage of glycosylated haemoglobin
Standard Deviation 0.78
|
-0.57 percentage of glycosylated haemoglobin
Standard Deviation 0.76
|
-0.62 percentage of glycosylated haemoglobin
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Week 0, Week 16Population: The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).
Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
-2.06 mmol/L
Standard Deviation 5.17
|
-1.60 mmol/L
Standard Deviation 4.66
|
-0.54 mmol/L
Standard Deviation 4.36
|
SECONDARY outcome
Timeframe: Week 16Population: The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).
Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
|
9.27 mmol/L
Standard Error 0.30
|
9.56 mmol/L
Standard Error 0.30
|
9.04 mmol/L
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Week 0 to Week 16 + 5 days follow upPopulation: The full analysis set (FAS) included all randomised subjects.
Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Rate of Major and Minor Hypoglycaemic Episodes
Major
|
46 Episodes/100 years of patient exposure
|
41 Episodes/100 years of patient exposure
|
36 Episodes/100 years of patient exposure
|
|
Rate of Major and Minor Hypoglycaemic Episodes
Minor
|
5838 Episodes/100 years of patient exposure
|
5305 Episodes/100 years of patient exposure
|
6637 Episodes/100 years of patient exposure
|
SECONDARY outcome
Timeframe: Week 0 to Week 16 + 5 days follow upPopulation: The full analysis set (FAS) included all randomised subjects.
Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Major
|
17 Episodes/100 years of patient exposure
|
12 Episodes/100 years of patient exposure
|
18 Episodes/100 years of patient exposure
|
|
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Minor
|
769 Episodes/100 years of patient exposure
|
546 Episodes/100 years of patient exposure
|
1082 Episodes/100 years of patient exposure
|
SECONDARY outcome
Timeframe: Week 0 to Week 16 + 5 days follow upPopulation: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Rate of Treatment Emergent Adverse Events (AEs)
Adverse events (AEs)
|
653 Events/100 years of patient exposure
|
874 Events/100 years of patient exposure
|
914 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Serious AEs
|
6 Events/100 years of patient exposure
|
12 Events/100 years of patient exposure
|
6 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Severe AEs
|
6 Events/100 years of patient exposure
|
29 Events/100 years of patient exposure
|
6 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Moderate AEs
|
202 Events/100 years of patient exposure
|
246 Events/100 years of patient exposure
|
397 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Mild AEs
|
445 Events/100 years of patient exposure
|
599 Events/100 years of patient exposure
|
511 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Fatal AEs
|
0 Events/100 years of patient exposure
|
0 Events/100 years of patient exposure
|
0 Events/100 years of patient exposure
|
SECONDARY outcome
Timeframe: Week -1, Week 16Population: The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.
Laboratory values at screening (Week -1) and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Week -1 , N=60, 59, 59
|
25.5 IU/L
Standard Deviation 11.3
|
22.7 IU/L
Standard Deviation 11.1
|
23.1 IU/L
Standard Deviation 10.2
|
|
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Week 16 , N=55, 53, 54
|
25.0 IU/L
Standard Deviation 12.0
|
21.2 IU/L
Standard Deviation 8.0
|
23.1 IU/L
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Week -1, Week 16Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.
Laboratory values at screening (Week -1) and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Week -1, N=60, 59, 59
|
22.8 IU/L
Standard Deviation 7.4
|
21.7 IU/L
Standard Deviation 7.0
|
23.3 IU/L
Standard Deviation 11.3
|
|
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Week 16, N=55, 53, 54
|
23.3 IU/L
Standard Deviation 8.8
|
21.6 IU/L
Standard Deviation 8.5
|
23.9 IU/L
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Week -1, Week 16Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.
Laboratory values at screening (Week -1) and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Week -1 , N=60, 59, 59
|
77.2 umol/L
Standard Deviation 12.6
|
76.6 umol/L
Standard Deviation 12.8
|
77.6 umol/L
Standard Deviation 13.3
|
|
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Week 16 , N=55, 53, 54
|
77.2 umol/L
Standard Deviation 14.1
|
75.9 umol/L
Standard Deviation 13.0
|
77.9 umol/L
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Week 0, Week 16Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.
Values at baseline (Week 0) and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Vital Signs: Diastolic BP (Blood Pressure)
Week 0 (Baseline), N=60, 59, 59
|
76 mmHg
Standard Deviation 8
|
75 mmHg
Standard Deviation 10
|
74 mmHg
Standard Deviation 9
|
|
Vital Signs: Diastolic BP (Blood Pressure)
Week 16, N=60, 57, 57
|
76 mmHg
Standard Deviation 10
|
75 mmHg
Standard Deviation 10
|
74 mmHg
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Week 0, Week 16Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.
Values at baseline (Week 0) and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Vital Signs: Systolic BP (Blood Pressure)
Week 0 (Baseline), N=60, 59, 59
|
124 mmHg
Standard Deviation 15
|
126 mmHg
Standard Deviation 16
|
124 mmHg
Standard Deviation 16
|
|
Vital Signs: Systolic BP (Blood Pressure)
Week 16, N=60, 57, 57
|
122 mmHg
Standard Deviation 14
|
125 mmHg
Standard Deviation 14
|
123 mmHg
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Week 0, Week 16Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.
Values at baseline (Week 0) and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=60 Participants
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Vital Signs: Pulse
Week 0 (Baseline), N=60, 59, 59
|
74 beats/minute
Standard Deviation 10
|
72 beats/minute
Standard Deviation 9
|
73 beats/minute
Standard Deviation 10
|
|
Vital Signs: Pulse
Week 16, N=60, 57, 57
|
74 beats/minute
Standard Deviation 12
|
72 beats/minute
Standard Deviation 11
|
72 beats/minute
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Week -1, Week 8, Week 16Physical examination was performed at screening (week -1), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.
Outcome measures
Outcome data not reported
Adverse Events
SIBA (D)
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
SIBA (E)
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
IGlar
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SIBA (D)
n=60 participants at risk
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 participants at risk
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 participants at risk
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/60 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
1.7%
1/59 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/59 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/60 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/59 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
1.7%
1/59 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.7%
1/60 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/59 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/59 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Metabolism and nutrition disorders
Hypoglycaemic unconsciousness
|
0.00%
0/60 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
1.7%
1/59 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/59 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
Other adverse events
| Measure |
SIBA (D)
n=60 participants at risk
Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
SIBA (E)
n=59 participants at risk
Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
IGlar
n=59 participants at risk
Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/60 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
5.1%
3/59 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
1.7%
1/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
3.4%
2/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
6.8%
4/59 • Number of events 6 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
2/60 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
8.5%
5/59 • Number of events 5 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
3.4%
2/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
3/60 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
5.1%
3/59 • Number of events 4 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
3.4%
2/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Influenza
|
6.7%
4/60 • Number of events 4 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
10.2%
6/59 • Number of events 7 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
5.1%
3/59 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Nasopharyngitis
|
23.3%
14/60 • Number of events 17 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
40.7%
24/59 • Number of events 29 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
25.4%
15/59 • Number of events 17 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Pharyngitis
|
1.7%
1/60 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
1.7%
1/59 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
5.1%
3/59 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Sinusitis
|
1.7%
1/60 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/59 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
6.8%
4/59 • Number of events 4 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
3/60 • Number of events 4 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
3.4%
2/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
11.9%
7/59 • Number of events 9 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
6/60 • Number of events 6 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
5.1%
3/59 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
3.4%
2/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Headache
|
16.7%
10/60 • Number of events 16 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
27.1%
16/59 • Number of events 35 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
16.9%
10/59 • Number of events 26 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
1/60 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
10.2%
6/59 • Number of events 7 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
3.4%
2/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
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