Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Japan. The aim for this trial is to investigate the pharmacodynamics and pharmacokinetics of insulin detemir and insulin NPH in Japanese subjects with type 1 diabetes mellitus.
Interventions
DRUGinsulin detemir
Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days
DRUGinsulin NPH
Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus * HbA1c (glycosylated haemoglobin) maximum 9.0% * Duration of diabetes at least 1 year * Body Mass Index (BMI) maximum 25.0 kg/m\^2
Exclusion criteria
* Recurrent severe hypoglycaemia * Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator * Impaired hepatic function * Impaired renal function * Cardiac problems * Uncontrolled treated / untreated hypertension * Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies, positive * Known or suspected allergy against the trial products or related products including the components * Previous history of serious allergy or anaphylactic reaction * Any disease or condition which the Investigator feel would interfere with the trial participation or evaluation of the results * Severe late-phase diabetic complications including nephropathy * Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 3 weeks * Known or suspected alcohol and illicit substance abuse or dependence * Pregnancy, breast-feeding (within a year after labour) or the intention to become pregnant * The receipt of any investigational drug within the last 12 weeks prior to this trial * Current or anticipated treatment with systemic corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| GIRmax, the maximum GIR value | — |
| tmax GIR, time to maximum GIR value | — |
| Cmax, maximum concentration | — |
| Area under the curve | — |
| AUCGIR, area under the glucose infusion rate value curve | — |
| MRT, mean residence time | — |
| t½, terminal half-life | — |
| Adverse events | — |
| tmax, time to maximum concentration | — |
Countries
Japan
Outcome results
None listed