Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.
Interventions
DRUGliraglutide
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy * Diet treated subjects: 7.5% \< HbA1c \< 10% * Single oral drug therapy subjects: 7.0% \< HbA1c \< 9.5% * Body Mass Index (BMI): max 40 kg/m\^2
Exclusion criteria
* Subjects treated with thiazolidinediones or insulin * Subjects with any serious medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 14 weeks treatment |
Secondary
| Measure | Time frame |
|---|---|
| Body weight after 14 weeks. | — |
| Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks. | — |
| Safety and tolerability | — |
Countries
Denmark, France, Netherlands, Slovakia
Outcome results
None listed