Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia. The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.
Interventions
DRUGinsulin detemir
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
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 with max. two OAD treatments * Body mass index below 30.0 kg/m2 * HbA1c between 7.0-11.0%
Exclusion criteria
* OAD treatment with three or more OADs * Secondary diabetes * Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator * Uncontrolled hypertension * Known or suspected allergy to trial product or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 20 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose (FPG) | — |
| Within-subject variation | — |
| Change in body weight | — |
| Incidence of adverse events | — |
Countries
India
Outcome results
None listed