Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in subjects with type 1 diabetes.
Interventions
DRUGFaster-acting insulin aspart
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
DRUGinsulin aspart
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
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 for more than 12 months * Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for more than 12 months * Body mass index (BMI) between 18.0-28.0 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 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 substitute products during the inpatient period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve | From 0 to 2 hours |
Secondary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve | From 0 to 12 hours |
| Maximum glucose infusion rate | Within 0 to 12 hours after dosing |
| Time to maximum glucose infusion rate | Within 0 to 12 hours after dosing |
Countries
Germany
Outcome results
None listed