Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.
Interventions
DRUGinsulin degludec
0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
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 (as diagnosed clinically) for at least 12 months * Body mass index 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 screening * 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 glucose infusion rate curve during one dosing interval at steady-date | After 8 days of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum Insulin Degludec concentration-time curve | During one dosing interval at steady state |
Countries
Austria
Outcome results
None listed