Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous insulin infusion (CSII).
Interventions
DRUGFaster-acting insulin aspart
Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion. The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.
DRUGinsulin aspart
Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion. The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.
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 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18-64 years (both inclusive) at the time of signing informed consent * Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * Body mass index (BMI) 18.5-28.0 kg/m\^2 (both inclusive) * Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
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 * Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) * Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve | From 0 to 30 minutes |
Secondary
| Measure | Time frame |
|---|---|
| CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve | From 0 to 1 hour |
| CSII bolus related baseline corrected area under the glucose infusion rate curve | From 0 to 1 hour |
Countries
Germany
Outcome results
None listed