Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes for more than 6 months * Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months * Body Mass Index (BMI) less than or equal to 40 kg/m2 * HbA1c 7.0-11.0%
Exclusion criteria
* Treatment with short acting insulin(s) for longer than 10 days * Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization * Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose profiles | — |
| Percentage of patients with HbA1c less than 7.0% after 52 weeks | — |
| Quality of Life | — |
| Safety parameters | — |
| Duration of education | — |
| Frequency of BG measurements | — |
Countries
Germany
Outcome results
None listed