Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.
Interventions
DRUGFaster-acting insulin aspart
Single dose injected subcutaneously (s.c, under the skin)
DRUGinsulin aspart
Single dose injected subcutaneously (s.c, under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer * Body mass index (BMI) 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) * Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum insulin aspart concentration-time curve | From 0-1 hour |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin aspart concentration-time curve | From 0-12 hours |
| Area under the glucose infusion rate (GIR) curve | From 0-1 hour |
Countries
Japan
Outcome results
None listed