Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).
Interventions
DRUGliraglutide
Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the 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 mellitus, including newly-diagnosed subjects, who require treatment with liraglutide
Exclusion criteria
* Subjects who are or have previously been on liraglutide * Subjects who have previously been enrolled in the study * Subjects with a hypersensitivity to liraglutide 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 cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial * Known or suspected abuse of alcohol or narcotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of SADRs (Serious Adverse Drug Reactions) | After 36 months |
Secondary
| Measure | Time frame |
|---|---|
| The incidence rate and type of SAEs (Serious Adverse Events) | At month 1, 3, 6, 12, 24 and 36 |
| The incidence rate and type of ADRs (Adverse Drug Reactions) | At month 1, 3, 6, 12, 24 and 36 |
Countries
Japan
Outcome results
None listed