Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes.
Interventions
DRUGinsulin detemir
On two dosing visits, 0.4 U/kg insulin detemir will be administered followed by 0.4 U/kg insulin glargine after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)
DRUGinsulin glargine
On two dosing visits, 0.4 U/kg insulin glargine will be administered followed by 0.4 U/kg insulin detemir after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes for at least 12 months * Body mass index (BMI) for children (6 to 12 years): 15-20 kg/m\^2 (both inclusive) * Body mass index (BMI) for adolescents (13 to 17 years): 18-25 kg/m\^2 (both inclusive) * HbA1c (glycosylated haemoglobin) below 11.0% according to central laboratory results * Current treatment with insulin at least twice daily
Exclusion criteria
* Any significant disease such as endocrine, hepatic, renal, cardiac, neurological, malignant, or pancreatic disease other than diabetes * Receipt of any investigational product within the last four weeks * Known or suspected allergy to trial products or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the insulin concentration curve (AUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum insulin concentration (Cmax) | — |
| Time to maximum insulin concentration (tmax) | — |
| Adverse events | — |
Countries
Germany
Outcome results
None listed