Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.
Interventions
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner
Administered subcutaneously (s.c., under the skin) at dinner
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Duration of diabetes for longer than 12 months * Body mass index (BMI) below 35.0 kg/m\^2 * HbA1c below 11.0 % * Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)
Exclusion criteria
* Current treatment with agents affecting glucose metabolism * History of drug or alcohol dependence * Impaired hepatic function * Impaired renal function * Cardiac disease * Proliferative retinopathy * Recurrent severe hypoglycaemia or advanced neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting serum glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour serum glucose profiles | — |
| 24-hour insulin profiles | — |
| Incidence of hypoglycaemic episodes | — |
| Incidence of adverse events | — |
Countries
Denmark
Outcome results
None listed