Trial Outcomes & Findings for Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes (NCT NCT00611884)
NCT ID: NCT00611884
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
245 participants
Primary outcome timeframe
Week 0, Week 16
Results posted on
2017-03-03
Participant Flow
There were 28 sites: Canada (4), India (4), South Africa (3) and the United States of America (17).
Subjects underwent a run-in period of 3 weeks; 2 weeks of up-titration period, where metformin was up-titrated to 1500 or 2000 mg/day, followed by 1 week of maintenance period. Subjects who tolerated 1500 or 2000 mg/day of metformin for a week and had a median fasting plasma glucose ≥ 7.5 mmol/L (135 mg/dL) were randomised.
Participant milestones
| Measure |
SIBA (D)
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
62
|
62
|
|
Overall Study
Exposed
|
58
|
59
|
61
|
61
|
|
Overall Study
COMPLETED
|
52
|
51
|
58
|
56
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
4
|
6
|
Reasons for withdrawal
| Measure |
SIBA (D)
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
|
Overall Study
Non-Compliance
|
1
|
4
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Overall Study
Unclassified
|
7
|
4
|
2
|
3
|
Baseline Characteristics
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
SIBA (D)
n=61 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=60 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=62 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
53.1 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
54.2 years
STANDARD_DEVIATION 9.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.7 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.1 • n=5 Participants
|
8.6 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.2 • n=7 Participants
|
8.8 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.1 • n=5 Participants
|
8.7 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.1 • n=4 Participants
|
8.7 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.1 • n=21 Participants
|
|
Fasting plasma glucose (FPG)
|
10.6 mmol/L
STANDARD_DEVIATION 3.6 • n=5 Participants
|
9.9 mmol/L
STANDARD_DEVIATION 3.2 • n=7 Participants
|
10.6 mmol/L
STANDARD_DEVIATION 3.4 • n=5 Participants
|
9.8 mmol/L
STANDARD_DEVIATION 3.1 • n=4 Participants
|
10.2 mmol/L
STANDARD_DEVIATION 3.4 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 16Population: The full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
Change from baseline in HbA1c after 16 weeks of treatment
Outcome measures
| Measure |
SIBA (D)
n=61 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=60 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=62 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-1.26 percentage of glycosylated haemoglobin
Standard Deviation 1.11
|
-1.28 percentage of glycosylated haemoglobin
Standard Deviation 1.11
|
-1.46 percentage of glycosylated haemoglobin
Standard Deviation 1.06
|
-1.49 percentage of glycosylated haemoglobin
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Week 16Population: The full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).
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 |
SIBA (D)
n=61 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=60 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=62 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
|
8.30 mmol/L
Standard Error 0.42
|
8.55 mmol/L
Standard Error 0.42
|
8.45 mmol/L
Standard Error 0.42
|
8.42 mmol/L
Standard Error 0.41
|
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=61 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=60 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=62 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Rate of Major and Minor Hypoglycaemic Episodes
Minor
|
89 Episodes/100 years of patient exposure
|
60 Episodes/100 years of patient exposure
|
221 Episodes/100 years of patient exposure
|
113 Episodes/100 years of patient exposure
|
|
Rate of Major and Minor Hypoglycaemic Episodes
Major
|
0 Episodes/100 years of patient exposure
|
0 Episodes/100 years of patient exposure
|
6 Episodes/100 years of patient exposure
|
0 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 |
SIBA (D)
n=61 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=60 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=62 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and 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
|
6 Episodes/100 years of patient exposure
|
0 Episodes/100 years of patient exposure
|
|
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Minor
|
6 Episodes/100 years of patient exposure
|
12 Episodes/100 years of patient exposure
|
17 Episodes/100 years of patient exposure
|
0 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=57 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=61 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Rate of Treatment Emergent Adverse Events (AEs)
Adverse events (AEs)
|
594 Events/100 years of patient exposure
|
430 Events/100 years of patient exposure
|
488 Events/100 years of patient exposure
|
622 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Serious AEs
|
6 Events/100 years of patient exposure
|
0 Events/100 years of patient exposure
|
5 Events/100 years of patient exposure
|
0 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Severe AEs
|
12 Events/100 years of patient exposure
|
6 Events/100 years of patient exposure
|
0 Events/100 years of patient exposure
|
28 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Moderate AEs
|
114 Events/100 years of patient exposure
|
102 Events/100 years of patient exposure
|
110 Events/100 years of patient exposure
|
141 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Mild AEs
|
468 Events/100 years of patient exposure
|
323 Events/100 years of patient exposure
|
379 Events/100 years of patient exposure
|
452 Events/100 years of patient exposure
|
|
Rate of Treatment Emergent Adverse Events (AEs)
Fatal
|
0 Events/100 years of patient exposure
|
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 -4, Week 16Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Mean values at Week -4 and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=57 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=61 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
ALAT, Week -4, N=56, 59, 62, 60
|
34.6 IU/L
Standard Deviation 19.9
|
29.2 IU/L
Standard Deviation 16.3
|
30.9 IU/L
Standard Deviation 16.0
|
32.9 IU/L
Standard Deviation 22.0
|
|
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
ALAT, Week 16, N=53, 53, 58, 56
|
25.7 IU/L
Standard Deviation 13.1
|
24.7 IU/L
Standard Deviation 14.4
|
24.3 IU/L
Standard Deviation 13.0
|
30.0 IU/L
Standard Deviation 25.3
|
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.
Mean values at Week -4 and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=57 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=61 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
ASAT, Week -4, N=56, 59, 62, 60
|
26.7 IU/L
Standard Deviation 13.6
|
22.5 IU/L
Standard Deviation 9.9
|
23.9 IU/L
Standard Deviation 8.5
|
24.2 IU/L
Standard Deviation 12.6
|
|
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
ASAT, Week 16, N=53, 53, 58, 56
|
23.3 IU/L
Standard Deviation 10.0
|
21.8 IU/L
Standard Deviation 7.7
|
21.7 IU/L
Standard Deviation 7.7
|
24.1 IU/L
Standard Deviation 13.7
|
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.
Mean values at Week -4 and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=57 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=61 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Creatinine, Week -4, N=56, 59, 62, 60
|
74.5 umol/L
Standard Deviation 15.2
|
75.4 umol/L
Standard Deviation 19.0
|
73.2 umol/L
Standard Deviation 16.1
|
72.4 umol/L
Standard Deviation 13.9
|
|
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Creatinine, Week 16, N=53, 53, 58, 56
|
76.1 umol/L
Standard Deviation 15.9
|
76.6 umol/L
Standard Deviation 19.1
|
71.5 umol/L
Standard Deviation 15.6
|
74.2 umol/L
Standard Deviation 14.4
|
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.
Mean values at baseline (Week 0) and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=57 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=61 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Vital Signs: Diastolic Blood Pressure (BP)
Week 0 (Baseline), N=57, 59, 62, 61
|
81 mmHg
Standard Deviation 9
|
82 mmHg
Standard Deviation 9
|
80 mmHg
Standard Deviation 8
|
79 mmHg
Standard Deviation 7
|
|
Vital Signs: Diastolic Blood Pressure (BP)
Week 16, N=55, 55, 60, 56
|
79 mmHg
Standard Deviation 8
|
82 mmHg
Standard Deviation 8
|
78 mmHg
Standard Deviation 9
|
77 mmHg
Standard Deviation 8
|
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.
Mean values at baseline (Week 0) and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=57 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=61 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Vital Signs: Systolic Blood Pressure (BP)
Week 0 (Baseline), N=57, 59, 62, 61
|
129 mmHg
Standard Deviation 14
|
131 mmHg
Standard Deviation 13
|
129 mmHg
Standard Deviation 15
|
127 mmHg
Standard Deviation 14
|
|
Vital Signs: Systolic Blood Pressure (BP)
Week 16, N=55, 55, 60, 56
|
126 mmHg
Standard Deviation 14
|
131 mmHg
Standard Deviation 15
|
126 mmHg
Standard Deviation 16
|
128 mmHg
Standard Deviation 13
|
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.
Mean values at baseline (Week 0) and at Week 16
Outcome measures
| Measure |
SIBA (D)
n=57 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=59 Participants
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 Participants
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=61 Participants
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Vital Signs: Pulse
Week 0 (Baseline), N=57, 59, 62, 61
|
79 beats/minute
Standard Deviation 10
|
79 beats/minute
Standard Deviation 9
|
79 beats/minute
Standard Deviation 9
|
76 beats/minute
Standard Deviation 9
|
|
Vital Signs: Pulse
Week 16, N=55, 55, 60, 56
|
77 beats/minute
Standard Deviation 11
|
78 beats/minute
Standard Deviation 10
|
79 beats/minute
Standard Deviation 9
|
74 beats/minute
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Week -4, Week 0, Week 8, Week 16Physical examination was performed at screening (Week -4), randomisation (Week 0) 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: 22 other events
Deaths: 0 deaths
SIBA (E)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
SIBA (D) M, W, F
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
IGlar
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SIBA (D)
n=57 participants at risk
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=59 participants at risk
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 participants at risk
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=61 participants at risk
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/57 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/59 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/62 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/61 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/57 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/59 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
1.6%
1/62 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/61 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
Other adverse events
| Measure |
SIBA (D)
n=57 participants at risk
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL \[1 dosing unit = 9 nmol\], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
|
SIBA (E)
n=59 participants at risk
Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
SIBA (D) M, W, F
n=62 participants at risk
Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday \[M\], Wednesday\[W\], Friday\[F\]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
|
IGlar
n=61 participants at risk
Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
3/57 • Number of events 4 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
5.1%
3/59 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
4.8%
3/62 • Number of events 5 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
9.8%
6/61 • Number of events 7 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Gastrointestinal disorders
Toothache
|
5.3%
3/57 • Number of events 4 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/59 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
3.2%
2/62 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
1.6%
1/61 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Infections and infestations
Influenza
|
1.8%
1/57 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
6.8%
4/59 • Number of events 4 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/62 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
1.6%
1/61 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Infections and infestations
Nasopharyngitis
|
3.5%
2/57 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
3.4%
2/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
6.5%
4/62 • Number of events 4 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
11.5%
7/61 • Number of events 7 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
5.3%
3/57 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
1.7%
1/59 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/62 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/61 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/57 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
5.1%
3/59 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
3.2%
2/62 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
3.3%
2/61 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
4/57 • Number of events 4 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/59 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
8.1%
5/62 • Number of events 6 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
4.9%
3/61 • Number of events 4 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
3/57 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
3.4%
2/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
3.2%
2/62 • Number of events 4 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
4.9%
3/61 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Nervous system disorders
Dizziness
|
1.8%
1/57 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
5.1%
3/59 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/62 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
3.3%
2/61 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Nervous system disorders
Headache
|
5.3%
3/57 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
3.4%
2/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
8.1%
5/62 • Number of events 7 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
13.1%
8/61 • Number of events 9 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Nervous system disorders
Paraesthesia
|
1.8%
1/57 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
5.1%
3/59 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/62 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
3.3%
2/61 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/57 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
3.4%
2/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
1.6%
1/62 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
8.2%
5/61 • Number of events 6 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
|
Vascular disorders
Hypertension
|
5.3%
3/57 • Number of events 3 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
1.7%
1/59 • Number of events 2 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
0.00%
0/62 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
1.6%
1/61 • Number of events 1 • The adverse events were collected in a time frame of 16 weeks + 5 days follow up
Subjects in the safety analysis set contribute to the evaluation "as treated", hence the one subject who was treated with SIBA (D) 3W although he was randomised to SIBA (D) OD is analysed as SIBA (D) 3W for safety and as SIBA (D) OD in the FAS.
|
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