| Outcome Measures: |
Primary: Insulin Detemir-insulin Aspart Cross-reacting Antibodies, Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection., week 0, 52 and 104 | Secondary: Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies, Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks., At 0, 52 and 104 weeks|Glycosylated Haemoglobin A1c (HbA1c), Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks., At 104 weeks|Fasting Plasma Glucose Values, FPG (Fasting Plasma Glucose) values after 104 weeks., At 104 weeks|Hypoglycaemic Episodes, Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment. Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment., Weeks 0-104|BMI (Body Mass Index), BMI (Body Mass Index) after 104 weeks., At 104 weeks|SD-score (Z-score) for Body Weight, Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2., At 104 weeks|Diabetic Ketoacidosis, Diabetic ketoacidosis requiring hospitalisation, At 104 weeks|Insulin Dose, Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104., At 104 weeks|Laboratory Values: Albumin Serum and Total Protein Serum (g/dL), Albumin Serum and Total Protein Serum after 104 weeks., At 104 weeks|Laboratory Values: Creatine Serum Umol/L, Creatine serum after 104 weeks., At 104 weeks|Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L), Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks., At 104 weeks|Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L), Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks., At 104 weeks|Laboratory Values: Leukocytes and Thrombocytes, Leukocytes and Thrombocytes after 104 weeks., At 104 weeks|Fundoscopy/Fundus Photography, Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant, at 52 weeks and at 104 weeks|Vital Signs: Blood Pressure, Blood pressure (Systolic and Diastolic) after 104 weeks., At 104 weeks|Vital Signs: Pulse, Pulse at week 104, At 104 weeks
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| Locations: |
Novo Nordisk Investigational Site, Pleven, 5800, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1606, Bulgaria|Novo Nordisk Investigational Site, Varna, 9010, Bulgaria|Novo Nordisk Investigational Site, Olomouc, 77520, Czech Republic|Novo Nordisk Investigational Site, Pardubice, 53203, Czech Republic|Novo Nordisk Investigational Site, Prague 5, 15018, Czech Republic|Novo Nordisk Investigational Site, Glostrup, 2600, Denmark|Novo Nordisk Investigational Site, Kolding, 6000, Denmark|Novo Nordisk Investigational Site, Odense, 5000, Denmark|Novo Nordisk Investigational Site, Helsinki, 00029, Finland|Novo Nordisk Investigational Site, Oulu, 90029, Finland|Novo Nordisk Investigational Site, Seinäjoki, 60220, Finland|Novo Nordisk Investigational Site, Turku, 20100, Finland|Novo Nordisk Investigational Site, Paris, 75015, France|Novo Nordisk Investigational Site, Toulouse, 31059, France|Novo Nordisk Investigational Site, Budapest, 1083, Hungary|Novo Nordisk Investigational Site, Miskolc, 3501, Hungary|Novo Nordisk Investigational Site, Skopje, 1000, Macedonia, The Former Yugoslav Republic of|Novo Nordisk Investigational Site, Gdansk, 80-211, Poland|Novo Nordisk Investigational Site, Kielce, 25-734, Poland|Novo Nordisk Investigational Site, Warszawa, 01-184, Poland|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Moscow, 119049, Russian Federation|Novo Nordisk Investigational Site, Moscow, 125373, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 193144, Russian Federation|Novo Nordisk Investigational Site, Altunizade-Istanbul, 34662, Turkey|Novo Nordisk Investigational Site, Antalya, 07059, Turkey|Novo Nordisk Investigational Site, Istanbul, 34093, Turkey|Novo Nordisk Investigational Site, Izmir, 35340, Turkey|Novo Nordisk Investigational Site, Aberdeen, AB25 2ZG, United Kingdom|Novo Nordisk Investigational Site, Dundee, DD1 9SY, United Kingdom|Novo Nordisk Investigational Site, Norfolk, NR4 7UY, United Kingdom
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