Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at steady-state conditions in subjects with type 1 diabetes mellitus.
Interventions
DRUGinsulin degludec
Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.
DRUGinsulin glargine
Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.
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 * Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening * Body mass index 18.5-29.0 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)who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve | During one dosing interval (0-24h) at steady-state. At day 6, 9 and 12 |
Secondary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve | During one dosing interval at steady state.At day 6, 9 and 12 |
Countries
Germany
Outcome results
None listed