Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia. The aim of this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2 diabetes mellitus.
Interventions
DRUGliraglutide
Administered either alone or in combination therapy according to the package insert (PI). Self-administered once daily, at any time subcutaneously (s.c., under the skin) in the abdomen, thigh or upper arm).
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects with T2DM (Type 2 Diabetes Mellitus), including newly-diagnosed subjects, who require treatment with Victoza® according to the clinical judgment of their treating physician * Subjects (and/or parents or the subject's legally acceptable representative) who are capable of giving study-specific signed informed consent before any collection of information
Exclusion criteria
* Subjects with a hypersensitivity to Victoza® or to any of the excipients * Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods * Subjects with personal or family history of medullary thyroid carcinoma (MTC) * Subjects with multiple endocrine neoplasia syndrome type 2 (MEN2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of SADRs (Serious Adverse Drug Reactions) | Up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c (Glycosylated haemoglobin) change | Month 0, month 6 |
| Percentage of subjects reaching the target of HbA1c below 7.0% | Month 6 |
| Change in body weight | Month 0, month 6 |
| Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions) | Up to 6 months |
Countries
South Korea
Outcome results
None listed