Diabetes, Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes Mellitus, Type I
Brief summary
This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.
Interventions
DRUGinsulin detemir
DRUGinsulin glargine
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
* Type 1 diabetes for at least 12 months * Current treatment with basal-bolus insulin regimen for more than or equal to 3 months * HbA1c less than or equal to 11.0%
Exclusion criteria
* Proliferative retinopathy or maculopathy * Recurrent major hypoglycaemia * Impaired hepatic or renal function * Cardiac problems or uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 1 year trial period |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
| Body weight | — |
| Hypoglycemia | — |
| Blood glucose | — |
| Insulin Treatment Satisfaction | — |
Countries
Finland, France, Germany, Netherlands, Sweden, United Kingdom, United States
Outcome results
None listed