Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).
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 * HbA1C greater than 7.5% and less than or equal to 11.0% * Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months
Exclusion criteria
* Previous acute treatment with insulin for more than 7 days. * Treatment with OAD(s) which does not adhere to the approval labeling. * Proliferate retinopathy or maculopathy that has required acute treatment within the last year. * Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 20 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| FBG | after 20 weeks of treatment |
| Safety profile | during 20 weeks treatment |
| Proportion of subjects achieving HbA1c less than or equal to 7.0% | after 20 weeks of treatment |
| Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial | before breakfast during the trial at the end of the trial |
Countries
China
Outcome results
None listed