Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.
Interventions
DRUGinsulin detemir
DRUGinsulin NPH
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Duration of type 1 diabetes for at least 12 months * BMI below 35 kg/m2 * HbA1c between 7.0-12.0% * Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months * Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator
Exclusion criteria
* Known or suspected allergy to trial product or related products * Previous participation in this trial * Receipt of any investigational products within the last 2 months prior to this trial * Drug or alcohol dependence * Pregnancy, breast-feeding or intention of becoming pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 26 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Plasma glucose profiles | — |
| Change in body weight | — |
| Quality of Life | — |
| Incidence of adverse events | — |
| Incidence of hypoglycaemic episodes | — |
Countries
Netherlands
Outcome results
None listed