Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.
Interventions
DRUGinsulin detemir
DRUGinsulin NPH
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 at least 12 months since diagnosis * Insulin naive subjects * OAD treatment for at least 4 months alone or combined with no more than two OADs * Body mass index (BMI) below 35.0 kg/m2 * HbA1c between 7.5-10.0% * Able and willing to use twice a day injections for the entire trial period
Exclusion criteria
* Current or previous treatment with thiazolidiones within the last 6 months * OAD treatment with three or more OADs within the last 6 months * Acute insulin treatment for longer than 7 days in a row within the last 6 months * Secondary diabetes * Known maturity onset of diabetes of young (MODY) * Known or suspected allergy to trial product or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 26 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Within-subject variation | — |
| Incidence of total hypoglycaemic episodes | — |
| Fasting plasma glucose | — |
| Incidence of adverse events | — |
| Insulin antibodies | — |
| Body weight | — |
Countries
Belgium, Croatia, Denmark, France, North Macedonia, Norway, Poland, Russia, Slovakia, Sweden
Outcome results
None listed