Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.
Interventions
DRUGliraglutide
DRUGinsulin glargine
DRUGmetformin
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: 7.5-10.0 % (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 kg/m2
Exclusion criteria
* Treatment with insulin within the last 3 months * Treatment with any drug that could interfere with the glucose level * Any serious medical condition * Females who are pregnant, have 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 | — |
| Glycaemic control | — |
Countries
Argentina, Austria, Brazil, Denmark, Finland, France, India, Italy, Netherlands, Norway, Philippines, Poland, Russia, Serbia and Montenegro, Slovakia, South Africa, Spain, United Kingdom
Outcome results
None listed