Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.
Interventions
DRUGbiphasic insulin aspart 30
Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 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 basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily * BMI (Body Mass Index) maximum 35 kg/m\^2 * Able and willing to perform self-blood glucose monitoring
Exclusion criteria
* 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/day * Currently being treated with insulin aspart products * A history of drug abuse or alcohol dependence within the last 5 years * Impaired hepatic function * Impaired renal function * Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory * Cardiac problems * Severe, uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steady state area under the glucose infusion rate profile, 6-12 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| tmax, time to maximum glucose infusion rate value | — |
| area under the glucose infusion rate profile | — |
| Time to 50% of area under the glucose infusion rate profile, 0-12 hours | — |
| Cmax, maximum concentration | — |
| GIRmax, the maximal glucose infusion rate value | — |
| Area under the curve | — |
| t½, terminal half-life | — |
| Adverse events | — |
| tmax, time to reach Cmax | — |
Countries
Germany
Outcome results
None listed