| Outcome Measures: |
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., week 0, week 52 | 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., Weeks 0-52|Glycaemic Control Parameters (Change in HbA1c), HbA1c (Glycosylated haemoglobin)., week 0, week 52|Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG]), week 0, week 52|Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]), 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, week 0, 26 and 52|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., Week 0, week 52|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., Week 0, week 52|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., week 0, week 52|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., Week 0, week 52|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., Week 0, week 52|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., Week 0, week 52|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., Week 0, week 52|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., Week 0, week 52|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., Week 0, week 52|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., Week 0, week 52|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, Week 0, week 52|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), Week 0, week 52|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), Week 0, week 52|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, Week 0, week 52|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), Week 0, week 52|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, Week 0, week 52|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, Week 0, week 52|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, Week 0, week 52|Adverse Events, Weeks 0-52
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