Diabetes, 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 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.
Interventions
DRUGbiphasic insulin aspart 30
Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with Type 2 diabetes * Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months * HbA1c maximum 10.0% * BMI (Body Mass Index) maximum 35.0 kg/m2 * Able and willing to perform self-blood glucose monitoring (SBGM)
Exclusion criteria
* The receipt of any investigational drug within the last 30 days prior to this trial * Total daily insulin dose minimum 2.0 U/(kg·day) * A history of drug abuse or alcohol dependence within the last 5 years * Impaired hepatic function * Impaired renal function * Cardiac disease * Severe, uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose average in 24-hour blood glucose profiles | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-meal excursion of glucose (0-4 hours) | — |
| Cmax, maximum concentration of total insulin | — |
| Pre-meal glucose level | — |
| The area under the 24-hour total insulin concentration time curve | — |
| Adverse events | — |
| tmax, time of maximum concentration of total insulin | — |
Countries
United Kingdom
Outcome results
None listed