Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.
Interventions
DRUGinsulin detemir
Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
DRUGinsulin aspart
Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
DRUGinsulin NPH
Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes for at least 12 months * Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months * BMI below or equal to 35 kg/m\^2 * HbA1c below or equal to 12%
Exclusion criteria
* Proliferative retinopathy or maculopathy requiring acute treatment * Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator) * Subjects with known hypoglycaemic unawareness as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c (glycosylated haemoglobin) | — |
Secondary
| Measure | Time frame |
|---|---|
| Intra-subject variation in home measured blood glucose (3-point blood glucose profiles) | — |
| 8-point blood glucose profiles | — |
| Incidence of self-recorded hypoglycaemic episodes | — |
| Incidence of adverse events | — |
Countries
Argentina, Croatia, Czechia, Denmark, Finland, France, Greece, Italy, North Macedonia, Norway, Poland, Romania, Russia, Slovakia, Sweden
Outcome results
None listed