Trial Outcomes & Findings for Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes (NCT NCT00613951)
NCT ID: NCT00613951
Last Updated: 2017-03-20
Results Overview
Change from baseline in HbA1c after 16 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
182 participants
Primary outcome timeframe
Week 0, Week 16
Results posted on
2017-03-20
Participant Flow
The trial was conducted at 27 sites in 5 countries: Finland (4), France (4), Germany (6), Poland (9) and Spain (4).
Subjects underwent a run-in period of up to 3 weeks (including 1-week maintenance period) where metformin was up-titrated to 1500 or 2000 mg/day. Subjects who tolerated metformin dose for a week and had fasting plasma glucose ≥ 7.5 mmol/L were randomised to SIAC 30 (B), SIAC 45 (B) or BIAsp 30 twice daily.
Participant milestones
| Measure |
SIAC 30 (B)
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
59
|
62
|
|
Overall Study
Exposed
|
60
|
59
|
62
|
|
Overall Study
COMPLETED
|
54
|
54
|
57
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
5
|
Reasons for withdrawal
| Measure |
SIAC 30 (B)
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
Unclassified
|
5
|
3
|
2
|
Baseline Characteristics
Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
SIAC 30 (B)
n=61 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.5 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.2 • n=5 Participants
|
8.5 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=7 Participants
|
8.6 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.0 • n=5 Participants
|
8.5 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.1 • n=4 Participants
|
|
Fasting plasma glucose (FPG)
|
11.4 mmol/L
STANDARD_DEVIATION 2.7 • n=5 Participants
|
11.8 mmol/L
STANDARD_DEVIATION 2.9 • n=7 Participants
|
11.7 mmol/L
STANDARD_DEVIATION 3.1 • n=5 Participants
|
11.6 mmol/L
STANDARD_DEVIATION 2.9 • 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). HbA1c values were missing for 2 subjects, hence did not contribute to the analysis
Change from baseline in HbA1c after 16 weeks of treatment
Outcome measures
| Measure |
SIAC 30 (B)
n=60 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=58 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-1.79 percentage of glycosylated haemoglobin
Standard Deviation 1.11
|
-1.87 percentage of glycosylated haemoglobin
Standard Deviation 0.91
|
-1.84 percentage of glycosylated haemoglobin
Standard Deviation 0.93
|
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). For 2 subjects, mean SMPG values were missing.
Estimate of the overall mean of SMPG 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, before bedtime, at 4 am and before breakfast.
Outcome measures
| Measure |
SIAC 30 (B)
n=60 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=58 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
|
7.52 mmol/L
Standard Error 0.27
|
7.44 mmol/L
Standard Error 0.28
|
7.52 mmol/L
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Week 0 to Week 16 + 5 days follow upPopulation: The full analysis set (FAS) included all randomised subjects.
Observed 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 |
SIAC 30 (B)
n=61 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Rate of Major and Minor Hypoglycaemic Episodes
Major
|
0 Episodes/100 years of patient exposure
|
0 Episodes/100 years of patient exposure
|
0 Episodes/100 years of patient exposure
|
|
Rate of Major and Minor Hypoglycaemic Episodes
Minor
|
287 Episodes/100 years of patient exposure
|
679 Episodes/100 years of patient exposure
|
730 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 05:59 (included).
Outcome measures
| Measure |
SIAC 30 (B)
n=61 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Major
|
0 Episodes/100 years of patient exposure
|
0 Episodes/100 years of patient exposure
|
0 Episodes/100 years of patient exposure
|
|
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Minor
|
39 Episodes/100 years of patient exposure
|
79 Episodes/100 years of patient exposure
|
108 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 |
SIAC 30 (B)
n=60 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Rate of Treatment Emergent Adverse Events (AEs)
Adverse events (AEs)
|
298 Events/100 years of patient exposure
|
545 Events/100 years of patient exposure
|
379 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Serious AEs
|
0 Events/100 years of patient exposure
|
0 Events/100 years of patient exposure
|
11 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Severe AEs
|
0 Events/100 years of patient exposure
|
0 Events/100 years of patient exposure
|
5 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Moderate AEs
|
56 Events/100 years of patient exposure
|
67 Events/100 years of patient exposure
|
38 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Mild AEs
|
242 Events/100 years of patient exposure
|
477 Events/100 years of patient exposure
|
335 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
|
5 Events/100 years of patient exposure
|
SECONDARY outcome
Timeframe: Week -4, Week 16Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.
Laboratory values at screening (Week -4) and at Week 16
Outcome measures
| Measure |
SIAC 30 (B)
n=60 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Week -4, N=60, 57, 62
|
33.0 IU/L
Standard Deviation 16.6
|
31.4 IU/L
Standard Deviation 16.0
|
36.9 IU/L
Standard Deviation 23.4
|
|
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Week 16, N=54, 57, 53
|
22.9 IU/L
Standard Deviation 9.2
|
22.5 IU/L
Standard Deviation 11.1
|
23.6 IU/L
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Week -4, Week 16Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 3 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.
Laboratory values at screening (Week -4) and at Week 16
Outcome measures
| Measure |
SIAC 30 (B)
n=60 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Week -4, N=60, 56, 62
|
23.6 IU/L
Standard Deviation 11.2
|
25.2 IU/L
Standard Deviation 12.0
|
26.4 IU/L
Standard Deviation 16.1
|
|
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Week 16, N=54, 57, 53
|
22.6 IU/L
Standard Deviation 8.7
|
22.9 IU/L
Standard Deviation 11.4
|
23.1 IU/L
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Week -4, Week 16Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 56 (SIAC 30), 57 (SIAC 45) and 56 (BIAsp 30) subjects contributed to the analysis at week 16.
Laboratory values at screening (Week -4) and at Week 16
Outcome measures
| Measure |
SIAC 30 (B)
n=60 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Week -4, N=60, 57, 62
|
72.7 umol/L
Standard Deviation 14.0
|
75.8 umol/L
Standard Deviation 14.8
|
74.8 umol/L
Standard Deviation 14.1
|
|
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Week 16, N=56, 57, 56
|
73.6 umol/L
Standard Deviation 13.2
|
76.3 umol/L
Standard Deviation 16.1
|
78.1 umol/L
Standard Deviation 15.5
|
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, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.
Values at baseline (Week 0) and at Week 16
Outcome measures
| Measure |
SIAC 30 (B)
n=60 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Vital Signs: Diastolic Blood Pressure (BP)
Week 0 (Baseline), N=60, 59, 62
|
80 mmHg
Standard Deviation 9
|
81 mmHg
Standard Deviation 10
|
81 mmHg
Standard Deviation 11
|
|
Vital Signs: Diastolic Blood Pressure (BP)
Week 16, N=58, 56, 58
|
78 mmHg
Standard Deviation 9
|
79 mmHg
Standard Deviation 10
|
76 mmHg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Week 0, Week 16Population: The safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.
Values at baseline (Week 0) and at Week 16
Outcome measures
| Measure |
SIAC 30 (B)
n=60 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Vital Signs: Systolic Blood Pressure (BP)
Week 0 (Baseline), N=60, 59, 62
|
134 mmHg
Standard Deviation 15
|
138 mmHg
Standard Deviation 18
|
137 mmHg
Standard Deviation 18
|
|
Vital Signs: Systolic Blood Pressure (BP)
Week 16, N=58, 56, 58
|
128 mmHg
Standard Deviation 13
|
135 mmHg
Standard Deviation 17
|
133 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, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.
Values at baseline (Week 0) and at Week 16
Outcome measures
| Measure |
SIAC 30 (B)
n=60 Participants
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 Participants
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Vital Signs: Pulse
Week 0 (Baseline), N=60, 59, 62
|
74 beats/minute
Standard Deviation 10
|
76 beats/minute
Standard Deviation 8
|
75 beats/minute
Standard Deviation 8
|
|
Vital Signs: Pulse
Week 16, N=58, 56, 58
|
73 beats/minute
Standard Deviation 10
|
73 beats/minute
Standard Deviation 8
|
77 beats/minute
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Week -4, Week 8, Week 16Physical examination was performed at screening (week -4), 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
SIAC 30 (B)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
SIAC 45 (B)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
BIAsp 30
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SIAC 30 (B)
n=60 participants at risk
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 participants at risk
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 participants at risk
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
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 with exposure information of at least one dose of randomised trial medication.
|
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 with exposure information of at least one dose of randomised trial medication.
|
1.6%
1/62 • 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 with exposure information of at least one dose of randomised trial medication.
|
|
Nervous system disorders
Ischaemic stroke
|
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 with exposure information of at least one dose of randomised trial medication.
|
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 with exposure information of at least one dose of randomised trial medication.
|
1.6%
1/62 • 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 with exposure information of at least one dose of randomised trial medication.
|
Other adverse events
| Measure |
SIAC 30 (B)
n=60 participants at risk
Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
SIAC 45 (B)
n=59 participants at risk
Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
BIAsp 30
n=62 participants at risk
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
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 with exposure information of at least one dose of randomised trial medication.
|
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 with exposure information of at least one dose of randomised trial medication.
|
1.6%
1/62 • 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 with exposure information of at least one dose of randomised trial medication.
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
8/60 • 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 with exposure information of at least one dose of randomised trial medication.
|
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 with exposure information of at least one dose of randomised trial medication.
|
8.1%
5/62 • 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 with exposure information of at least one dose of randomised trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
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 with exposure information of at least one dose of randomised trial medication.
|
5.1%
3/59 • 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 with exposure information of at least one dose of randomised trial medication.
|
4.8%
3/62 • 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 with exposure information of at least one dose of randomised trial medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
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 with exposure information of at least one dose of randomised trial medication.
|
1.7%
1/59 • 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 with exposure information of at least one dose of randomised trial medication.
|
6.5%
4/62 • 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 with exposure information of at least one dose of randomised trial medication.
|
|
Nervous system disorders
Headache
|
10.0%
6/60 • Number of events 10 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
The safety analysis set included all subjects with exposure information of at least one dose of randomised trial medication.
|
8.5%
5/59 • 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 with exposure information of at least one dose of randomised trial medication.
|
1.6%
1/62 • 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 with exposure information of at least one dose of randomised trial medication.
|
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