Diabetes Mellitus, Type 1
Conditions
Brief summary
The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.
Interventions
DRUGInsulin detemir
DRUGNPH insulin
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent obtained before any trial-related activities * Type 1 diabetes diagnosed and classified according to aetiology * Duration of type 1 diabetes equal to or more than 12 months * Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory * Able and willing to perform self-blood glucose monitoring
Exclusion criteria
* Proliferative retinopathy * Total basal insulin dose of more than 100 IU per day * Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator) * Known unawareness of hypoglycaemia * Previous treatment with insulin detemir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the level of glycosylated haemoglobin(HbA1c) | From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26) |
Countries
Australia, Belgium, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom
Outcome results
None listed