Non-Interventional Study on Safety of Liraglutide in Subjects With Type 2 Diabetes
- Registration Number
- NCT01345734
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Asia. The aim of this trial is to investigate the safety profile of liraglutide under normal conditions of use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1056
Inclusion Criteria
- Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects or those already receiving other anti-diabetic medications including GLP-1 analogues other than Liraglutide, who require treatment with liraglutide according to the clinical judgment of their treating physician
- Subjects who are capable of giving study-specific signed informed consent before any collection of information
Exclusion Criteria
- Subjects with type 1 diabetes
- Subjects who are or have previously been on liraglutide
- Subjects who are participating in another clinical trial
- Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
- Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Liraglutide liraglutide -
- Primary Outcome Measures
Name Time Method Incidence of serious adverse drug reactions (SADRs) Week 0, week 26
- Secondary Outcome Measures
Name Time Method Incidence of adverse drug reactions (ADRs) Week 0, week 26 Incidence of serious adverse events (SAEs) Week 0, week 26 Change in HbA1c (glycosylated haemoglobin)" Week 0, week 26 Frequency of hypoglycaemic episodes Week 0, week 26
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇵🇭Manilla, Philippines