Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689
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|ClinicalTrials.gov Identifier: NCT00623194|
Recruitment Status : Completed
First Posted : February 25, 2008
Results First Posted : January 24, 2011
Last Update Posted : November 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 1||Drug: insulin detemir Drug: insulin aspart||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623194
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|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|