Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.
Interventions
DRUGbiphasic insulin aspart
DRUGmetformin
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 99 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Currently treated with maximum doses of any kind of OAD alone or any kind of oral combination therapy for at least 2 months * Body mass index (BMI) below 40.0 kg/m2 * HbA1c between 7.5-13.0%
Exclusion criteria
* History of drug or alcohol dependence * Mental incapacity, unwillingness or language barriers precluding adequate * Subjects previously screened to participation or having already participated in this trial * Receipt of any investigational drug within the last month prior to this trial * Known or suspected allergy to trial products or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 24 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Plasma glucose profiles | — |
| Cardiovascular risk factors | — |
| Incidence of hypoglycaemic episodes | — |
| Adverse events | — |
Countries
South Africa
Outcome results
None listed