Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial was conducted in Europe. The aim of this clinical trial was to evaluate the blood glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2 diabetes.
Interventions
DRUGinsulin degludec
Insulin degludec (IDeg) injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject was randomly allocated to 2 out of 4 treatments.
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
* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months * Body mass index (BMI) below or equal to 35.0 kg/m2
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 more than 5 cigarettes or the equivalent per day) * Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve from 0-24 hours at steady state | 0-24 hours (derived on treatment day 6) |
Secondary
| Measure | Time frame |
|---|---|
| Area under the insulin degludec concentration-time curve from 0-24 hours at steady state | 0-24 hours (derived on treatment day 6) |
Countries
Germany
Outcome results
None listed