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 FIAsp (faster-acting insulin aspart) in subjects with type 1 diabetes.
Interventions
DRUGFaster-acting insulin aspart
A single dose will be administered subcutaneously (under the skin) in the abdomen. Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.
DRUGinsulin aspart
A single dose will be administered subcutaneously (under the skin)) in the abdomen. Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.
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 64 Years
Healthy volunteers
No
Inclusion criteria
* 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 more than 5 cigarettes or the equivalent per day) * Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period inpatient period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in plasma glucose concentration | From 0-2 hours after administration |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin aspart concentration-time curve | From 0 to 1 hour |
Countries
Austria
Outcome results
None listed