Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the exposure of NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1 diabetes mellitus.
Interventions
DRUGinsulin degludec/insulin aspart
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.
DRUGbiphasic insulin aspart 30
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group) * Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * Body mass index 18.0-28.0 kg/m\^2 (both inclusive) * HbA1c (glycosylated haemoglobin A1c) maximum 10.0% by central laboratory analysis
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 * Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the Glucose Infusion Rate curve (only for NN5401) | from 0 to 24 hours after single-dose administration |
Secondary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve (only for biphasic insulin aspart 30) | from 0 to 24 hours after single-dose administration |
Countries
Austria
Outcome results
None listed