Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the difference in frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30 compared to biphasic human insulin 30 in subjects with well controlled type 2 diabetes.
Interventions
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
DRUGbiphasic insulin aspart 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
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 * Treated with insulin 1-3 injections daily for at least 6 months * Body Mass Index (BMI) below 40 kg/m\^2 * HbA1c (glycosylated haemoglobin A1c) below 9.5% at screening
Exclusion criteria
* Total insulin dosage more than 1.8 IU/kg * Impaired hepatic or renal function or significant cardiac problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of hypoglycaemic episodes | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of reported severe hypoglycaemic episodes | — |
| Overall frequency of nocturnal hypoglycaemia | — |
| HbA1c (glycosylated haemoglobin A1c) | — |
| Diabetes Treatment Satisfaction Questionaire | — |
Countries
United Kingdom
Outcome results
None listed