Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.
Interventions
DRUGbiphasic insulin aspart
DRUGinsulin glargine
DRUGmetformin
DRUGpioglitazone
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Insulin naive Type 2 diabetes * Currently treated with OADs alone or combined with other treatment for at least 3 months * BMI below 40 kg/m2 and body weight below 125 kg * HbA1c greater than or equal to 8%
Exclusion criteria
* Inability to tolerate metformin or contradictions to its use * Pregnant, breastfeeding or intention of becoming pregnant * Allergy to any of the trial products * Inability or unwillingness to perform SMBG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 28 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Postprandial glucose by 8-point SMBG | — |
| Number of subjects achieving HbA1c below 7% | — |
| Number of hypoglycemic episodes and adverse events | — |
| Weight change | — |
| Insulin dose | — |
Countries
United States
Outcome results
None listed