Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.
Interventions
DRUGinsulin degludec
NN1250 (insulin degludec) injected s.c. (under the skin) once daily for 6 days
DRUGinsulin detemir
Insulin detemir injected s.c. (under the skin) once daily for 6 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
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months * Current daily basal insulin requirement above or equal to 0.3 (I)U/kg/day * Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)
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 * Surgery or trauma with significant blood loss (more than 500 mL) within the last 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 (only clamp period)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the NN1250 GIR (glucose infusion rate) curve | During one dosing interval at steady state |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin detemir concentration-time curve | During one dosing interval at steady state |
Countries
Japan
Outcome results
None listed