Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.
Interventions
DRUGbiphasic insulin aspart
DRUGinsulin glargine
DRUGmetformin
DRUGglimepiride
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 2 diabetes for at least 6 months * Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed * Previous treatment with oral antidiabetic drugs for at least 4 months * Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen * BMI below 40 kg/m2 * HbA1c between 7-12% * Able and willing to perform self-plasma glucose monitoring
Exclusion criteria
* The receipt of any other investigational drug within 4 weeks before screening * A history of drug or alcohol abuse within the last 12 months * Severe, uncontrolled hypertension * Known or suspected allergy to trial products or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 26 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c | after 16 weeks of treatment |
| Plasma glucose profiles | — |
| Change in body mass index | — |
| Incidence of hypoglycaemic episodes | — |
| Safety profile | — |
Countries
Austria, Czechia, Germany, Hungary, Poland, Slovakia, Slovenia
Outcome results
None listed