Diabetes, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
Liraglutide will be prescribed and titrated by the treating physician and will be self-administered by the subject s.c. (under the skin) once daily. Study participants being treated with GLP-1 (Glucagon-Like Peptide 1)agonists or DDP-4-inhibitors (Dipeptidyl-peptidase 4 ) should stop treatment when initiating liraglutide treatment.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse drug reactions (SADRs) | Week 0, week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions (ADRs) | Week 0, week 26 |
| Incidence of serious adverse events (SAEs) | Week 0, week 26 |
| Frequency of hypoglycaemic episodes | Week 0, week 26 |
| Change in HbA1c (glycosylated haemoglobin) | Week 0, week 26 |
Countries
Philippines