Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).
Interventions
DRUGbiphasic insulin aspart 30
Dose individually adjusted. Administered once daily for 16 weeks. If HbA1c after 16 weeks of treatment is above 7.0%, insulin is administered twice daily for additional 16 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus for at least 12 months * HbA1c between 7.5-14.5% (inclusive) at screening * Insulin naïve * An antidiabetic regimen that has been stable for at least 3 months prior to screening * An antidiabetic regimen that includes a minimum of 2 OADs
Exclusion criteria
* Use of any insulin preparations within the past 6 months * Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0% | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c | — |
| Total number of hypoglycemic events | — |
| Adverse events | — |
Countries
Mexico
Outcome results
None listed