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) properties of FIAsp (faster-acting insulin aspart) in children, adolescents and adults with type 1 diabetes.
Interventions
DRUGFaster-acting insulin aspart
A single dose will be administered subcutaneously (s.c. under the skin)
DRUGinsulin aspart
A single dose will be administered 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
6 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 6-64 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 (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults equal to or below 28.0 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 * 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 to 12 hours |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed serum insulin aspart concentration | From 0-12 hours |
Countries
Germany
Outcome results
None listed