Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in subjects with type 2 diabetes.
Interventions
DRUGinsulin detemir
Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)
DRUGinsulin NPH
Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)
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 2 diabetes * Subjects treated with insulin for minimum 3 months * Duration of diabetes for at least 12 months * Body Mass Index (BMI) below 30 kg/m\^2 * HbA1c maximum 10% based on analysis from central laboratory
Exclusion criteria
* Current treatment with insulin above 1.2 U/kg/day * Current treatment with insulin glargine * Current treatment with drugs known to interfere with glucose metabolism * Current treatment with oral antidiabetic drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum glucose | — |
| Area under the curve | — |
| Maximum concentration | — |
| Time to maximum concentration | — |
| Maximum glucose infusion rate | — |
| Mean residence time of insulin | — |
| Terminal rate constant | — |
| Terminal half-life | — |
| Insulin clearance | — |
Countries
Germany
Outcome results
None listed