Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus
Interventions
DRUGFaster-acting insulin aspart
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
DRUGInsulin Aspart
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
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 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed 25. * Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening * HbA1C below or equal to 9.5 % based on central laboratory analysis
Exclusion criteria
* Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period * Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum insulin aspart concentration-time curve | From 0 to 30 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed serum insulin aspart concentration | Within 0 to 12 hours after dosing |
| Area under the glucose infusion rate curve | From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing) |
| Maximum glucose infusion rate | Within 0 to 12 hours after dosing |
Countries
Austria
Outcome results
None listed