Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial was conducted in Europe. The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes.
Interventions
DRUGinsulin degludec/insulin aspart
Insulin degludec/insulin aspart administered as a single subcutaneous injection (under the skin).
Sponsors
HNEC TEST
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * Body mass index for children: 15.0-20.0 kg/m\^2 (both inclusive), for adolescents: 18.0-28.0 kg/m\^2 (both inclusive) and for adults maximum 30.0 kg/m\^2
Exclusion criteria
* Subject who has donated any blood or plasma in the past month, or more than 500 mL within 3 months prior to screening * Not able or willing to refrain from smoking during the inpatient period * Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum insulin degludec concentration-time curve | from 0 to infinity after single-dose |
| Area under the serum insulin aspart concentration-time curve | from 0 to 12 hours after single-dose |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed | from 0 to 57 hours after single-dose |
| Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed | from 0 to 12 hours after single-dose |
Countries
Germany
Outcome results
None listed