Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).
Interventions
DRUGinsulin detemir
DRUGinsulin aspart
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 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes for more than 1 year * Subject treated by any kind of insulin regimen and whatever the number of injections * HbA1c = 7.5% and = 10%
Exclusion criteria
* Type 2 diabetes * Treatment by oral anti-diabetic drugs * Severe medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean HbA1c | after 4 months of insulin detemir treatment |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
| Insulin dose requirements during initial 4 months of treatment and during 3 months extension | — |
| HbA1c | — |
| Blood glucose | — |
| Hypoglycaemia | — |
| Weight | — |
Countries
Belgium, France, Luxembourg
Outcome results
None listed