Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Asia. The aim of this study is to evaluate the safety and effectiveness of liraglutide in subjects with type 2 diabetes mellitus.
Interventions
DRUGliraglutide
Self-administered subcutaneously (under the skin) once daily at any time, independent of meals, 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 type 2 diabetes, including newly-diagnosed patients / those already receiving other anti-diabetic medications including GLP-1 analogues, 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 have previously been enrolled in the study * 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 |
|---|---|
| The number of serious adverse drug reactions (SADRs) during the study period | during 26 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| The number of adverse drug reactions (ADR) during the study period | during 26 weeks of treatment |
| The number of serious adverse events (SAE) during the study period | during 26 weeks of treatment |
| Frequency of hypoglycaemic episodes | during 26 weeks of treatment |
Countries
India
Outcome results
None listed