Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689
|Diabetes Diabetes Mellitus, Type 1||Drug: insulin detemir Drug: insulin aspart||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin|
- Insulin Detemir-insulin Aspart Cross-reacting Antibodies [ Time Frame: week 0, 52 and 104 ]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.
- Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies [ Time Frame: At 0, 52 and 104 weeks ]Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks.
- Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: At 104 weeks ]Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.
- Fasting Plasma Glucose Values [ Time Frame: At 104 weeks ]FPG (Fasting Plasma Glucose) values after 104 weeks.
- Hypoglycaemic Episodes [ Time Frame: Weeks 0-104 ]
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.
- BMI (Body Mass Index) [ Time Frame: At 104 weeks ]BMI (Body Mass Index) after 104 weeks.
- SD-score (Z-score) for Body Weight [ Time Frame: At 104 weeks ]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.
- Diabetic Ketoacidosis [ Time Frame: At 104 weeks ]Diabetic ketoacidosis requiring hospitalisation
- Insulin Dose [ Time Frame: At 104 weeks ]Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.
- Laboratory Values: Albumin Serum and Total Protein Serum (g/dL) [ Time Frame: At 104 weeks ]Albumin Serum and Total Protein Serum after 104 weeks.
- Laboratory Values: Creatine Serum Umol/L [ Time Frame: At 104 weeks ]Creatine serum after 104 weeks.
- Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L) [ Time Frame: At 104 weeks ]Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.
- Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L) [ Time Frame: At 104 weeks ]Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.
- Laboratory Values: Leukocytes and Thrombocytes [ Time Frame: At 104 weeks ]Leukocytes and Thrombocytes after 104 weeks.
- Fundoscopy/Fundus Photography [ Time Frame: at 52 weeks and at 104 weeks ]
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
- Vital Signs: Blood Pressure [ Time Frame: At 104 weeks ]Blood pressure (Systolic and Diastolic) after 104 weeks.
- Vital Signs: Pulse [ Time Frame: At 104 weeks ]Pulse at week 104
|Study Start Date:||February 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: insulin detemir
Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
Drug: insulin detemir
Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.Drug: insulin aspart
Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623194
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|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|