Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate steady state pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.
Interventions
DRUGbiphasic insulin aspart 30
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes for at least 12 months * Currently on a multiple dose insulin regimen * HbA1c maximum 12.0% * BMI (body mass index) below 35 kg/m\^2 * Able and willing to perform self-blood glucose monitoring (SBGM)
Exclusion criteria
* Treatment with insulin aspart within the last 14 days prior to this trial * The receipt of any investigational drug within the last 30 days prior to this trial * Total daily insulin dose at least 1.8 U/kg * A history of drug abuse or alcohol dependence within the last 5 years * Impaired hepatic function * Impaired renal function * Blood donation within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory * Cardiac disease * Severe, uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum insulin curve 6-14 hours after dinner at day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin curve 0-6 hours after dinner | — |
| Area under the curve 0-24 hours | — |
| Serum insulin | — |
| Area under the serum insulin curve 6-14 hours after dinner at day 1 | — |
| Cmax, maximum concentration | — |
| tmax, time to reach Cmax | — |
| Adverse events | — |
| Apparent t½ (apparent elimination half life) | — |
Countries
Denmark
Outcome results
None listed