| Primary | Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies | 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. | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Error | ratio | | week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001.81± 0.07
- OG0011.89± 0.07
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Null hypothesis:Treatment with detemir produced with the NN729 process result in a similar change in cross reacting antibody levels as the NN304 process. Alternative hypothesis: change in antibody levels differ after treatment with detemir produced by the two manufacturing processes. The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. | ANOVA | Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data). | 0.649 | | Treatment Ratio | 1.04 | | | | 95 | 0.86 | 1.26 | | | The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated. |
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| Secondary | Hypoglycaemic Episodes | 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. | All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Number | | episodes | | Weeks 0-52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Glycaemic Control Parameters (Change in HbA1c) | HbA1c (Glycosylated haemoglobin). | All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Error | Percent (%) glycosylated haemoglobin | | week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG]) | | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Error | mmol/L | | week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) |
- point is Before Breakfast
- point is 120 minutes after Breakfast
- point is Before Lunch
- point is 120 minutes after Lunch
- point is Before Dinner
- point is 120 minutes after Dinner
- point is at Bedtime
- point is At 03:00 A.M.
- point is Before Breakfast the Following Day
| FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, 26 and 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Change From Baseline in Detemir Specific Antibodies | 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. | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Error | ratio | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Change From Baseline in Total Antibodies | 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. | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Error | ratio | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Haematology - Basophilis) | 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. | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | Percent (%) of white blood cells | | week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Haematology - Eosinophils) | 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. | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | Percent (%) of white blood cells | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Haematology - Haemoglobin) | 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. | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Haematology - Lymphocytes) | 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. | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | Percent (%) of white blood cells | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Haematology - Monocytes) | 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. | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | Percent (%) of white blood cells | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Haematology - Neutrophils) | 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. | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | Percent (%) of white blood cells | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Haematology - Thrombocytes) | 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. | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | 10^9/L | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Haematology - Leucocytes) | 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. | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | Percent (%) of white blood cells | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Biochemistry - Albumin) | 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 | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | g/dL | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT]) | 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) | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | U/L | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP]) | 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) | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | U/L | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Biochemistry - Creatinine) | 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 | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a postbaseline observation. | Posted | | Mean | Standard Deviation | Umol/L | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH]) | 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) | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | U/L | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Biochemistry - Potassium) | 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 | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Biochemistry - Sodium) | 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 | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Clinical Laboratory Values (Change in Biochemistry - Total Protein) | 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 | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Mean | Standard Deviation | g/dL | | Week 0, week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Adverse Events | | FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation. | Posted | | Number | | events | | Weeks 0-52 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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