Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.
Interventions
DRUGinsulin aspart
At the first treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. At the second treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.
DRUGinsulin human
At the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.At the second treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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 for at least 12 months * Current daily basal insulin requirement above or equal to 0.3 U/kg/day * Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% * Body Mass Index (BMI) 18.0-28.0 kg/m\^2
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 (screening) * Surgery or trauma with significant blood loss (more than 500 mL) within 3 months prior to trial start (screening) * Subject who smokes more than 10 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 |
|---|---|
| Clearance at steady state (CLss) for IV treatment group | from 180 min to 240 min |
| Area under the curve (AUC) for IM treatment group | from 0 to 480 min after intramuscular injection |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) for IM treatment group | from 0 minutes to infinite time after intramuscular injection |
| Steady state concentration (Css) for IV treatment group | from 180 min to 240 min |
| Hypoglycaemic episodes | from screening (visit 1) to follow-up visit (2-21 days after last trial product administration) |
| Adverse Events (AEs) | from first trial related activity to follow-up visit (2-21 days after last trial product administration) |
Countries
Japan
Outcome results
None listed