Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.
Interventions
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being obese with a body mass index (BMI) exceeding 30 kg/m\^2 will receive BIAsp 50
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m\^2 will receive BIAsp 70
Administered subcutaneously (s.c., under the skin), twice a day
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 1 or Type 2 diabetes * Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents * Body mass index (BMI) maximum 40.0 kg/m\^2
Exclusion criteria
* History of drug or alcohol dependence * Impaired hepatic function * Impaired renal function * Cardiac disease * Proliferative retinopathy * Total daily insulin dose at least 1.80 IU/kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c (glycosylated haemoglobin A1c) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose profiles | — |
| Adverse events | — |
| Hypoglycaemic episodes | — |
| Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ) | — |
| Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2) | — |
Countries
Belgium, France, Ireland, Netherlands, United Kingdom
Outcome results
None listed