Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.
Interventions
DRUGbiphasic insulin aspart 30
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
DRUGinsulin aspart
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
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 55 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes for at least 12 months * Serum C-peptide maximum 0.4 ng/mL * Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine * BMI (Body Mass Index) maximum 32 kg/m\^2 * HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory * Non-smoker
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 * Current treatment with IAsp (insulin aspart) products * A history of drug or alcohol abuse within the last 5 years * Impaired hepatic function * Impaired renal function * Cardiac problems * Severe, uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum GIR value | — |
| Area under the GIR-curves | — |
| Maximum drug concentration for insulin aspart (IAsp) | — |
| Time to maximum IAsp concentration | — |
| Area under the curve of the IAsp profiles | — |
| Maximum GIR value | — |
| Time to minimum plasma concentration, NEFA | — |
| Area under the curve of the NEFA profiles | — |
| Adverse events | — |
| Hypoglycaemic episodes | — |
| Minimum drug concentration in NEFA (Nonesterified fatty acids) | — |
Countries
Germany
Outcome results
None listed