Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.
Interventions
DRUGliraglutide
DRUGrosiglitazone
DRUGglimepiride
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 * Treatment with oral anti-diabetic drugs for at least 3 months * HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy * Body Mass Index (BMI) less than or equal to 45.0 kg/m2.
Exclusion criteria
* Treatment with insulin within the last three months * Treatment with any drug that could interfere with the glucose level * Any serious medical condition * Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 26 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| body weight | — |
| Safety and tolerability | — |
| beta-cell function | — |
| Glycemic control parameters (fasting plasma glucose, -glucose profiles) | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Croatia, Czechia, Finland, France, Greece, India, Israel, Italy, Malaysia, Philippines, Poland, Romania, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye)
Outcome results
None listed