Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes
A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus
3 other identifiers
observational
4,121
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 19, 2011
CompletedFirst Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2015
CompletedFebruary 12, 2018
February 1, 2018
4.4 years
July 21, 2011
February 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of SADRs (Serious Adverse Drug Reactions)
After 36 months
Secondary Outcomes (2)
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
Study Arms (1)
Liraglutide
Interventions
Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm
Eligibility Criteria
Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who are considered to need treatment with liraglutide (Victoza®)
You may qualify if:
- Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Tokyo, 1000005, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 27, 2011
Study Start
July 19, 2011
Primary Completion
December 28, 2015
Study Completion
December 28, 2015
Last Updated
February 12, 2018
Record last verified: 2018-02