Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.
Interventions
DRUGinsulin aspart
Injected s.c. (under the skin) three times a day
DRUGhuman insulin
Injected s.c. (under the skin) 30 minutes before the meals
May be administered s.c. (under the skin) in both treatment groups thrice daily
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes * Treatment with insulin for at least 6 months prior to inclusion * HbA1c below or equal to 11.0 % * Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion
Exclusion criteria
* The receipt of any investigational drug within one month prior to this trial * Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator * Total daily insulin doses at least 1.80 IU/kg * Treatment with oral hypoglycaemic agents * Known or suspected allergy to trial product or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hypoglycaemic episodes during the treatment | Week 0; week 24 |
| Change in HbA1c (glycosylated haemoglobin A1c) | Week 0; week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs) | Week 0; week 24 |
Countries
Germany
Outcome results
None listed