Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A 6-month, Multi-centre, Open Labelled, Non-randomized, Non-interventional, Safety Study of Liraglutide (Victoza®) in Subjects With Type 2 Diabetes Mellitus in Korea
| Verified date | August 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | March 8, 2017 |
| Est. primary completion date | March 8, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Novo Nordisk Investigational Site | Pyungchon-Dong 896, Dongan-Gu | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Korea, Republic of | Novo Nordisk Investigational Site | Ulsan | |
| Korea, Republic of | Novo Nordisk Investigational Site | Ulsan | |
| Korea, Republic of | Novo Nordisk Investigational Site | Wonju |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The incidence of SADRs (Serious Adverse Drug Reactions) | Up to 6 months | ||
| Secondary | HbA1c (Glycosylated haemoglobin) change | Month 0, month 6 | ||
| Secondary | Percentage of subjects reaching the target of HbA1c below 7.0% | Month 6 | ||
| Secondary | Change in body weight | Month 0, month 6 | ||
| Secondary | Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions) | Up to 6 months |
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