Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.
Interventions
DRUGliraglutide
DRUGrosiglitazone
DRUGmetformin
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Treated with oral anti-diabetic (OAD) drugs for at least 3 months * Treated with one or more OAD and in moderate to poor glycemic control * Body Mass Index (BMI) less than or equal to 45.0 kg/m2
Exclusion criteria
* Treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the Investigator * Any serious medical condition * Treatment with any drug that could interfere with glucose level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 26 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability | — |
| Glycaemic control | — |
| body weight | — |
Countries
Canada, United States
Outcome results
None listed