Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.
Interventions
DRUGFaster-acting insulin aspart
Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).
DRUGinsulin aspart
Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products 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
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 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) * 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 glucose infusion rate curve | From 0 to 12 hours |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin aspart concentration-time curve | From 0 to 12 hours |
| Maximum glucose infusion rate | Within 0 to 12 hours after dosing |
| Maximum observed serum insulin aspart concentration | Within 0 to 12 hours after dosing |
Countries
Germany
Outcome results
None listed