Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 diabetes.
Interventions
DRUGNN1218
0.2 U/kg body weight injected subcutaneously (under the skin)
DRUGinsulin aspart
0.2 U/kg body weight injected subcutaneously (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 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus for more than 12 months * Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months * Body mass index (BMI) between 18.0-28.0 kg/m2 (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 trial start * 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 gum or transdermal nicotine patches during the inpatient period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum NN1218 concentration-time curve | From 0-1 hours |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum NN1218 concentration-time curve | From 0-10 hours |
Countries
Germany
Outcome results
None listed