Trial Outcomes & Findings for Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes (NCT NCT00447382)
NCT ID: NCT00447382
Last Updated: 2024-01-02
Results Overview
Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
COMPLETED
PHASE3
330 participants
week 0, week 52
2024-01-02
Participant Flow
Twenty four sites in five countries: Germany (12), The Republic of Macedonia (1), Russian Federation (4), Serbia (3) and South Africa (4)
Eligible subjects were adults with type 1 diabetes treated with a basal-bolus regimen for at least 3 months prior to the study, who had a BMI (Body Mass Index) no greater than 35.0 kg/m\^2 and HbA1c no greater than 12.0%.
Participant milestones
| Measure |
NN729
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN304
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
164
|
|
Overall Study
COMPLETED
|
160
|
158
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
NN729
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN304
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Unclassified
|
5
|
2
|
Baseline Characteristics
Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 14.9 • n=99 Participants
|
38.6 years
STANDARD_DEVIATION 13.6 • n=107 Participants
|
39.3 years
STANDARD_DEVIATION 14.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
185 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
152 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
304 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Height
|
1.74 meter
STANDARD_DEVIATION 0.09 • n=99 Participants
|
1.72 meter
STANDARD_DEVIATION 0.1 • n=107 Participants
|
1.73 meter
STANDARD_DEVIATION 0.1 • n=206 Participants
|
|
Body weight
|
77.6 kg
STANDARD_DEVIATION 14.6 • n=99 Participants
|
75.1 kg
STANDARD_DEVIATION 14.9 • n=107 Participants
|
76.4 kg
STANDARD_DEVIATION 14.7 • n=206 Participants
|
|
BMI (Body Mass Index)
|
25.68 kg/m^2
STANDARD_DEVIATION 4.05 • n=99 Participants
|
25.23 kg/m^2
STANDARD_DEVIATION 3.59 • n=107 Participants
|
25.45 kg/m^2
STANDARD_DEVIATION 3.83 • n=206 Participants
|
|
HbA1c (Glycosylated haemoglobin)
|
7.93 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 1.31 • n=99 Participants
|
7.99 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 1.38 • n=107 Participants
|
7.96 Percent (%) glycosylated haemoglobin
STANDARD_DEVIATION 1.35 • n=206 Participants
|
|
Diabetes History
|
14.48 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
13.66 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
14.07 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
Outcome measures
| Measure |
NN304
n=158 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=152 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies
|
1.81 ratio
Standard Error 0.07
|
1.89 ratio
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Weeks 0-52Population: All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Hypoglycaemic episodes occurring in the time frame between 23:00 hours (included) and 06:00 hours (excluded) were defined as nocturnal.
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Hypoglycaemic Episodes
All events - Major
|
21 episodes
|
21 episodes
|
|
Hypoglycaemic Episodes
All events - Minor
|
3215 episodes
|
2996 episodes
|
|
Hypoglycaemic Episodes
All events - Symptoms Only
|
445 episodes
|
318 episodes
|
|
Hypoglycaemic Episodes
Daytime - Major
|
9 episodes
|
15 episodes
|
|
Hypoglycaemic Episodes
Daytime - Minor
|
2741 episodes
|
2590 episodes
|
|
Hypoglycaemic Episodes
Daytime - Symptoms Only
|
381 episodes
|
258 episodes
|
|
Hypoglycaemic Episodes
Nocturnal - Major
|
12 episodes
|
6 episodes
|
|
Hypoglycaemic Episodes
Nocturnal - Minor
|
472 episodes
|
404 episodes
|
|
Hypoglycaemic Episodes
Nocturnal - Symptoms Only
|
64 episodes
|
60 episodes
|
|
Hypoglycaemic Episodes
Unclassified - Minor
|
2 episodes
|
2 episodes
|
SECONDARY outcome
Timeframe: week 0, week 52Population: All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
HbA1c (Glycosylated haemoglobin).
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=165 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Glycaemic Control Parameters (Change in HbA1c)
Week 52
|
7.88 Percent (%) glycosylated haemoglobin
Standard Error 0.07
|
7.85 Percent (%) glycosylated haemoglobin
Standard Error 0.07
|
|
Glycaemic Control Parameters (Change in HbA1c)
Change from Baseline to week 52
|
-0.08 Percent (%) glycosylated haemoglobin
Standard Error 0.07
|
-0.11 Percent (%) glycosylated haemoglobin
Standard Error 0.07
|
SECONDARY outcome
Timeframe: week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=165 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])
Week 52
|
9.73 mmol/L
Standard Error 0.3
|
9.64 mmol/L
Standard Error 0.3
|
|
Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])
Change from Baseline to week 52
|
0.07 mmol/L
Standard Error 0.3
|
-0.02 mmol/L
Standard Error 0.3
|
SECONDARY outcome
Timeframe: week 0, 26 and 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
1. point is Before Breakfast 2. point is 120 minutes after Breakfast 3. point is Before Lunch 4. point is 120 minutes after Lunch 5. point is Before Dinner 6. point is 120 minutes after Dinner 7. point is at Bedtime 8. point is At 03:00 A.M. 9. point is Before Breakfast the Following Day
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 52 change. 1. point
|
-0.60 mmol/L
Standard Deviation 4.08
|
-0.67 mmol/L
Standard Deviation 3.85
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 26 change. 6. point
|
-0.35 mmol/L
Standard Deviation 4.16
|
0.07 mmol/L
Standard Deviation 4.7
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 52 change. 3. point
|
-0.36 mmol/L
Standard Deviation 3.96
|
-0.28 mmol/L
Standard Deviation 4.06
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Baseline 1. point
|
8.17 mmol/L
Standard Deviation 3.26
|
8.17 mmol/L
Standard Deviation 3.56
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Baseline 2. point
|
8.95 mmol/L
Standard Deviation 3.86
|
9.03 mmol/L
Standard Deviation 3.81
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Baseline 3. point
|
7.66 mmol/L
Standard Deviation 3.36
|
7.34 mmol/L
Standard Deviation 3.51
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Baseline 4. point
|
8.60 mmol/L
Standard Deviation 3.70
|
8.18 mmol/L
Standard Deviation 3.74
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Baseline 5. point
|
8.29 mmol/L
Standard Deviation 3.37
|
8.16 mmol/L
Standard Deviation 3.84
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Baseline 6. point
|
8.43 mmol/L
Standard Deviation 3.37
|
8.60 mmol/L
Standard Deviation 3.75
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Baseline 7. point
|
8.69 mmol/L
Standard Deviation 3.48
|
8.60 mmol/L
Standard Deviation 3.70
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Baseline 8. point
|
7.97 mmol/L
Standard Deviation 3.51
|
7.72 mmol/L
Standard Deviation 3.47
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Baseline 9. point
|
8.05 mmol/L
Standard Deviation 3.49
|
7.56 mmol/L
Standard Deviation 3.24
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 26 change. 1. point
|
-0.64 mmol/L
Standard Deviation 3.95
|
-0.44 mmol/L
Standard Deviation 4.38
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 26 change. 2. point
|
-0.61 mmol/L
Standard Deviation 4.43
|
-0.61 mmol/L
Standard Deviation 4.81
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 26 change. 3. point
|
-0.49 mmol/L
Standard Deviation 3.64
|
0.08 mmol/L
Standard Deviation 4.04
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 26 change. 4. point
|
-0.34 mmol/L
Standard Deviation 3.82
|
-0.22 mmol/L
Standard Deviation 4.27
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 26 change. 5. point
|
-0.36 mmol/L
Standard Deviation 4.22
|
-0.00 mmol/L
Standard Deviation 4.32
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 26 change. 7. point
|
-0.35 mmol/L
Standard Deviation 3.63
|
0.20 mmol/L
Standard Deviation 4.37
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 26 change. 8. point
|
0.18 mmol/L
Standard Deviation 4.05
|
0.08 mmol/L
Standard Deviation 4.19
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 26 change. 9. point
|
-0.64 mmol/L
Standard Deviation 4.05
|
0.24 mmol/L
Standard Deviation 3.54
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 52 change. 2. point
|
-0.54 mmol/L
Standard Deviation 4.80
|
-0.99 mmol/L
Standard Deviation 4.04
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 52 change. 4. point
|
-0.78 mmol/L
Standard Deviation 3.98
|
-0.29 mmol/L
Standard Deviation 3.93
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 52 change. 5. point
|
-0.41 mmol/L
Standard Deviation 3.80
|
-0.59 mmol/L
Standard Deviation 4.33
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 52 change. 6. point
|
-0.31 mmol/L
Standard Deviation 4.13
|
-0.51 mmol/L
Standard Deviation 4.04
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 52 change. 7. point
|
-0.34 mmol/L
Standard Deviation 3.92
|
-0.47 mmol/L
Standard Deviation 3.68
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 52 change. 8. point
|
-0.24 mmol/L
Standard Deviation 3.59
|
-0.31 mmol/L
Standard Deviation 3.77
|
|
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Week 52 change. 9. point
|
-0.44 mmol/L
Standard Deviation 4.14
|
-0.09 mmol/L
Standard Deviation 3.49
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Measured change in concentrations of antibody values for insulin detemir specific antibodies and the change ratio from the baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
Outcome measures
| Measure |
NN304
n=150 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=150 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Change From Baseline in Detemir Specific Antibodies
|
1.14 ratio
Standard Error 0.04
|
1.06 ratio
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Measured change in concentrations of total insulin antibodies values (the sum of insulin detemir specific and insulin detemir - human insulin cross-reacting antibodies) and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
Outcome measures
| Measure |
NN304
n=150 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=147 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Change From Baseline in Total Antibodies
|
1.55 ratio
Standard Error 0.05
|
1.55 ratio
Standard Error 0.05
|
SECONDARY outcome
Timeframe: week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Outcome measures
| Measure |
NN304
n=17 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=12 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Haematology - Basophilis)
Baseline
|
0.30 Percent (%) of white blood cells
Standard Deviation 0.67
|
0.36 Percent (%) of white blood cells
Standard Deviation 0.50
|
|
Clinical Laboratory Values (Change in Haematology - Basophilis)
Week 52
|
0.24 Percent (%) of white blood cells
Standard Deviation 0.56
|
0.33 Percent (%) of white blood cells
Standard Deviation 0.49
|
|
Clinical Laboratory Values (Change in Haematology - Basophilis)
Change from Baseline to week 52
|
-0.25 Percent (%) of white blood cells
Standard Deviation 0.50
|
0.00 Percent (%) of white blood cells
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Outcome measures
| Measure |
NN304
n=10 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=11 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Haematology - Eosinophils)
Baseline
|
2.50 Percent (%) of white blood cells
Standard Deviation 1.27
|
1.82 Percent (%) of white blood cells
Standard Deviation 1.40
|
|
Clinical Laboratory Values (Change in Haematology - Eosinophils)
Week 52
|
2.47 Percent (%) of white blood cells
Standard Deviation 2.10
|
2.08 Percent (%) of white blood cells
Standard Deviation 2.35
|
|
Clinical Laboratory Values (Change in Haematology - Eosinophils)
Change from Baseline to week 52
|
-0.25 Percent (%) of white blood cells
Standard Deviation 2.22
|
0.00 Percent (%) of white blood cells
Standard Deviation 3.61
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Outcome measures
| Measure |
NN304
n=161 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=160 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Haematology - Haemoglobin)
Baseline
|
8.85 mmol/L
Standard Deviation 0.92
|
8.80 mmol/L
Standard Deviation 0.79
|
|
Clinical Laboratory Values (Change in Haematology - Haemoglobin)
Week 52
|
8.54 mmol/L
Standard Deviation 0.91
|
8.47 mmol/L
Standard Deviation 0.76
|
|
Clinical Laboratory Values (Change in Haematology - Haemoglobin)
Change from Baseline to week 52
|
-0.30 mmol/L
Standard Deviation 0.52
|
-0.31 mmol/L
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Outcome measures
| Measure |
NN304
n=10 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=11 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Haematology - Lymphocytes)
Baseline
|
33.80 Percent (%) of white blood cells
Standard Deviation 6.94
|
37.45 Percent (%) of white blood cells
Standard Deviation 7.66
|
|
Clinical Laboratory Values (Change in Haematology - Lymphocytes)
Week 52
|
28.12 Percent (%) of white blood cells
Standard Deviation 9.17
|
36.67 Percent (%) of white blood cells
Standard Deviation 9.30
|
|
Clinical Laboratory Values (Change in Haematology - Lymphocytes)
Change from Baseline to week 52
|
-3.25 Percent (%) of white blood cells
Standard Deviation 9.18
|
5.33 Percent (%) of white blood cells
Standard Deviation 6.66
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Outcome measures
| Measure |
NN304
n=4 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=3 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Haematology - Monocytes)
Baseline
|
3.40 Percent (%) of white blood cells
Standard Deviation 2.17
|
4.00 Percent (%) of white blood cells
Standard Deviation 2.61
|
|
Clinical Laboratory Values (Change in Haematology - Monocytes)
Week 52
|
3.59 Percent (%) of white blood cells
Standard Deviation 2.92
|
3.42 Percent (%) of white blood cells
Standard Deviation 2.15
|
|
Clinical Laboratory Values (Change in Haematology - Monocytes)
Change from Baseline to week 52
|
-2.50 Percent (%) of white blood cells
Standard Deviation 1.91
|
0.67 Percent (%) of white blood cells
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Outcome measures
| Measure |
NN304
n=10 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=11 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Haematology - Neutrophils)
Week 52
|
65.59 Percent (%) of white blood cells
Standard Deviation 10.75
|
57.50 Percent (%) of white blood cells
Standard Deviation 9.60
|
|
Clinical Laboratory Values (Change in Haematology - Neutrophils)
Change from Baseline to week 52
|
6.25 Percent (%) of white blood cells
Standard Deviation 10.37
|
-6.00 Percent (%) of white blood cells
Standard Deviation 8.66
|
|
Clinical Laboratory Values (Change in Haematology - Neutrophils)
Baseline
|
60.00 Percent (%) of white blood cells
Standard Deviation 7.51
|
56.36 Percent (%) of white blood cells
Standard Deviation 7.46
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Outcome measures
| Measure |
NN304
n=163 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=165 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Haematology - Thrombocytes)
Baseline
|
254.0 10^9/L
Standard Deviation 65.5
|
267.1 10^9/L
Standard Deviation 59.5
|
|
Clinical Laboratory Values (Change in Haematology - Thrombocytes)
Week 52
|
242.2 10^9/L
Standard Deviation 58.3
|
247.2 10^9/L
Standard Deviation 51.3
|
|
Clinical Laboratory Values (Change in Haematology - Thrombocytes)
Change from Baseline to week 52
|
-12.8 10^9/L
Standard Deviation 38.5
|
-18.6 10^9/L
Standard Deviation 38.9
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Haematology - Leucocytes)
Change from Baseline to week 52
|
0.03 Percent (%) of white blood cells
Standard Deviation 1.77
|
-0.32 Percent (%) of white blood cells
Standard Deviation 1.69
|
|
Clinical Laboratory Values (Change in Haematology - Leucocytes)
Baseline
|
6.22 Percent (%) of white blood cells
Standard Deviation 1.91
|
6.3 Percent (%) of white blood cells
Standard Deviation 1.71
|
|
Clinical Laboratory Values (Change in Haematology - Leucocytes)
Week 52
|
6.24 Percent (%) of white blood cells
Standard Deviation 1.85
|
5.96 Percent (%) of white blood cells
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Biochemistry - Albumin)
Baseline
|
4.30 g/dL
Standard Deviation 0.23
|
4.27 g/dL
Standard Deviation 0.23
|
|
Clinical Laboratory Values (Change in Biochemistry - Albumin)
Week 52
|
4.28 g/dL
Standard Deviation 0.25
|
4.30 g/dL
Standard Deviation 0.22
|
|
Clinical Laboratory Values (Change in Biochemistry - Albumin)
Change from Baseline to week 52
|
-0.02 g/dL
Standard Deviation 0.21
|
0.02 g/dL
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (ALAT = alanine aminotransferase)
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])
Baseline
|
29.21 U/L
Standard Deviation 22.12
|
25.98 U/L
Standard Deviation 13.65
|
|
Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])
Week 52
|
30.72 U/L
Standard Deviation 25.48
|
27.81 U/L
Standard Deviation 16.05
|
|
Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])
Change from Baseline to week 52
|
1.34 U/L
Standard Deviation 17.80
|
1.76 U/L
Standard Deviation 17.17
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (ALP = alkaline phosphatase)
Outcome measures
| Measure |
NN304
n=161 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=161 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])
Baseline
|
75.40 U/L
Standard Deviation 23.26
|
75.55 U/L
Standard Deviation 25.30
|
|
Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])
Week 52
|
82.35 U/L
Standard Deviation 47.20
|
80.42 U/L
Standard Deviation 23.98
|
|
Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])
Change from Baseline to week 52
|
6.77 U/L
Standard Deviation 42.36
|
4.53 U/L
Standard Deviation 15.88
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a postbaseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Biochemistry - Creatinine)
Baseline
|
73.1 Umol/L
Standard Deviation 15.4
|
72.3 Umol/L
Standard Deviation 31.6
|
|
Clinical Laboratory Values (Change in Biochemistry - Creatinine)
Week 52
|
72.5 Umol/L
Standard Deviation 16.4
|
73.1 Umol/L
Standard Deviation 63.4
|
|
Clinical Laboratory Values (Change in Biochemistry - Creatinine)
Change from Baseline to week 52
|
-0.5 Umol/L
Standard Deviation 11.0
|
0.8 Umol/L
Standard Deviation 33.7
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (LDH = lactate dehydrogenase)
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])
Week 52
|
164.9 U/L
Standard Deviation 62
|
162.7 U/L
Standard Deviation 37.5
|
|
Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])
Baseline
|
161.1 U/L
Standard Deviation 47.8
|
159.4 U/L
Standard Deviation 57.4
|
|
Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])
Change from Baseline to week 52
|
3.2 U/L
Standard Deviation 45
|
2.6 U/L
Standard Deviation 46.7
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Biochemistry - Potassium)
Baseline
|
4.46 mmol/L
Standard Deviation 0.44
|
4.37 mmol/L
Standard Deviation 0.49
|
|
Clinical Laboratory Values (Change in Biochemistry - Potassium)
Week 52
|
4.49 mmol/L
Standard Deviation 0.49
|
4.43 mmol/L
Standard Deviation 0.44
|
|
Clinical Laboratory Values (Change in Biochemistry - Potassium)
Change from Baseline to week 52
|
0.02 mmol/L
Standard Deviation 0.50
|
0.06 mmol/L
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Biochemistry - Sodium)
Baseline
|
138.9 mmol/L
Standard Deviation 2.6
|
139.2 mmol/L
Standard Deviation 2.4
|
|
Clinical Laboratory Values (Change in Biochemistry - Sodium)
Week 52
|
140.3 mmol/L
Standard Deviation 2.4
|
140.0 mmol/L
Standard Deviation 2.4
|
|
Clinical Laboratory Values (Change in Biochemistry - Sodium)
Change from Baseline to week 52
|
1.4 mmol/L
Standard Deviation 2.8
|
0.8 mmol/L
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Clinical Laboratory Values (Change in Biochemistry - Total Protein)
Baseline
|
7.23 g/dL
Standard Deviation 0.44
|
7.24 g/dL
Standard Deviation 0.44
|
|
Clinical Laboratory Values (Change in Biochemistry - Total Protein)
Week 52
|
7.13 g/dL
Standard Deviation 0.44
|
7.19 g/dL
Standard Deviation 0.43
|
|
Clinical Laboratory Values (Change in Biochemistry - Total Protein)
Change from Baseline to week 52
|
-0.11 g/dL
Standard Deviation 0.38
|
-0.06 g/dL
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Weeks 0-52Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
Outcome measures
| Measure |
NN304
n=164 Participants
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 Participants
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Adverse Events
Serious Adverse Events
|
25 events
|
10 events
|
|
Adverse Events
Non-Serious Adverse Events
|
259 events
|
346 events
|
Adverse Events
NN304
NN729
Serious adverse events
| Measure |
NN304
n=164 participants at risk
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 participants at risk
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemic Unconsciousness
|
1.8%
3/164 • Number of events 4 • Weeks 0-52
|
1.2%
2/166 • Number of events 2 • Weeks 0-52
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.2%
2/164 • Number of events 2 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Metabolism and nutrition disorders
Dehydration
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Metabolism and nutrition disorders
Hypoglycaemic
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Metabolism and nutrition disorders
Ketosis
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Infections and infestations
Gastroenteritis
|
1.2%
2/164 • Number of events 2 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Infections and infestations
Bronchiectasis
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/164 • Weeks 0-52
|
0.60%
1/166 • Number of events 1 • Weeks 0-52
|
|
Infections and infestations
Pneumonia
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.00%
0/164 • Weeks 0-52
|
0.60%
1/166 • Number of events 1 • Weeks 0-52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer
|
0.00%
0/164 • Weeks 0-52
|
0.60%
1/166 • Number of events 1 • Weeks 0-52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone Sarcoma
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/164 • Weeks 0-52
|
0.60%
1/166 • Number of events 1 • Weeks 0-52
|
|
Nervous system disorders
Facial Paresis
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Nervous system disorders
Hypoglycaemic Coma
|
0.00%
0/164 • Weeks 0-52
|
0.60%
1/166 • Number of events 1 • Weeks 0-52
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/164 • Weeks 0-52
|
0.60%
1/166 • Number of events 1 • Weeks 0-52
|
|
Gastrointestinal disorders
Pancreatitis
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Gastrointestinal disorders
Pancreatitis Relapsing
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Blood and lymphatic system disorders
Lymphadenopathy Mediastinal
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Cardiac disorders
Atrial Fibrillation
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Ear and labyrinth disorders
Vertigo
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Hepatobiliary disorders
Portal Hypertension
|
0.00%
0/164 • Weeks 0-52
|
0.60%
1/166 • Number of events 1 • Weeks 0-52
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/164 • Weeks 0-52
|
0.60%
1/166 • Number of events 1 • Weeks 0-52
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
|
Vascular disorders
Vascular Disorders
|
0.61%
1/164 • Number of events 1 • Weeks 0-52
|
0.00%
0/166 • Weeks 0-52
|
Other adverse events
| Measure |
NN304
n=164 participants at risk
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
NN729
n=166 participants at risk
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.9%
26/164 • Number of events 33 • Weeks 0-52
|
18.7%
31/166 • Number of events 37 • Weeks 0-52
|
|
Infections and infestations
Influenza
|
6.7%
11/164 • Number of events 11 • Weeks 0-52
|
6.6%
11/166 • Number of events 17 • Weeks 0-52
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.5%
9/164 • Number of events 10 • Weeks 0-52
|
6.6%
11/166 • Number of events 14 • Weeks 0-52
|
|
Nervous system disorders
Headache
|
6.1%
10/164 • Number of events 30 • Weeks 0-52
|
10.2%
17/166 • Number of events 59 • Weeks 0-52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee One or more manuscripts for publication will be prepared in collaboration between Investigator(s) and Novo Nordisk. Novo Nordisk will not suppress or veto publications; however Novo Nordisk reserves the right to postpone publication and/or communication for a short time to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER