Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.
Interventions
DRUGinsulin detemir
DRUGinsulin NPH
DRUGinsulin aspart
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes for at least 12 months * Informed consent obtained * BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m2. * HbA1c equal to or less than 12.0%
Exclusion criteria
* Proliferate retinopathy or maculopathy * Total daily insulin dose greater than 2.00 IU/kg * Any condition or disease that rule out trial participation according to the judgement of the investigator. * Mental incapacity, unwillingness or language barriers precluding understanding or cooperation. * A life-style incompatible with trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
| body weight | — |
| Antibodies | — |
| Blood glucose | — |
| Hypoglycaemia | — |
Countries
Belgium, Croatia, Denmark, Finland, France, Germany, Ireland, Israel, Netherlands, North Macedonia, Norway, Slovenia, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed