Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.
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 * Currently treated with Oral Antidiabetic Drugs * BMI lesser than or equal to 40 kg/m2 * HbA1c greater than or equal 7.5 and lesser than or equal to 11%
Exclusion criteria
* Proliferative retinopathy or maculopathy * Recurrent major hypoglycaemia * uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1C | after 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Hypoglycemia | — |
| Blood glucose | — |
| Adverse events | — |
| body weight | — |
Countries
Denmark, France, Italy, Netherlands, Norway, Spain, United States
Outcome results
None listed