Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.
Interventions
DRUGbiphasic insulin aspart
DRUGinsulin NPH
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 * Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs * HbA1c between 8.0-10.5% * Body mass index (BMI) below 35.0 kg/m2 * Able and willing to perform self-monitoring of blood glucose
Exclusion criteria
* Total daily insulin dose of 1.80 IU/kg or more * Known or suspected allergy to trial product or related products * Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 4 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| 8-point blood glucose profile | — |
| incidence of hypoglycaemic episodes | — |
| safety profiles | — |
| changes in body weight and vital signs | — |
Countries
Croatia, France, Germany, Hong Kong, Malaysia, Netherlands, Poland, Romania, Russia, Singapore, Spain, Sweden, United Kingdom
Outcome results
None listed