Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial was conducted in Europe. The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults with type 1 diabetes.
Interventions
DRUGinsulin degludec
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
DRUGinsulin glargine
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 6-65 years (both inclusive) * 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 NN1250 concentration-time curve after single dose | 0-72 hours after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed NN1250 concentration after single dose | 0-72 hours after dosing |
| Time to maximum observed NN1250 concentration after single dose | 0-72 hours after dosing |
Countries
Germany
Outcome results
None listed