Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of faster-acting insulin aspart in subjects with Type 1 diabetes.
Interventions
DRUGFaster-acting insulin aspart
Subjects will receive a single dose of either Faster-acting insulin aspart or NovoRapid® at a predefined fixed dose level in connection to intake of a standardised meal. Administered subcutaneously (s.c., under the skin)
DRUGinsulin aspart
Subjects will receive a single dose of either Faster-acting insulin aspart or NovoRapid® at a predefined fixed dose level in connection to intake of a standardised meal. Administered subcutaneously (s.c., under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 18-64 years (both inclusive) at the time of signing informed consent * Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * Body mass index 18.5-28.0 kg/m\^2 (both inclusive)
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 at least one cigarette, cigar or pipe daily)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean plasma glucose concentration | From 0-6 hours after start of a standardised meal |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin aspart concentration-time curve | From 0 to 12 hours after trial product administration |
Countries
Austria
Outcome results
None listed