Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus
- Registration Number
- NCT01821846
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Liraglutide liraglutide -
- Primary Outcome Measures
Name Time Method The incidence of SADRs (Serious Adverse Drug Reactions) Up to 6 months
- Secondary Outcome Measures
Name Time Method Change in body weight Month 0, month 6 Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions) Up to 6 months HbA1c (Glycosylated haemoglobin) change Month 0, month 6 Percentage of subjects reaching the target of HbA1c below 7.0% Month 6
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇰🇷Wonju, Korea, Republic of