- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01403025
Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes
February 9, 2018 updated by: Novo Nordisk A/S
A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
4121
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tokyo, Japan, 1000005
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who are considered to need treatment with liraglutide (Victoza®)
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Liraglutide
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Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of SADRs (Serious Adverse Drug Reactions)
Time Frame: After 36 months
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After 36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence rate and type of SAEs (Serious Adverse Events)
Time Frame: At month 1, 3, 6, 12, 24 and 36
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At month 1, 3, 6, 12, 24 and 36
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The incidence rate and type of ADRs (Adverse Drug Reactions)
Time Frame: At month 1, 3, 6, 12, 24 and 36
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At month 1, 3, 6, 12, 24 and 36
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 19, 2011
Primary Completion (Actual)
December 28, 2015
Study Completion (Actual)
December 28, 2015
Study Registration Dates
First Submitted
July 21, 2011
First Submitted That Met QC Criteria
July 26, 2011
First Posted (Estimate)
July 27, 2011
Study Record Updates
Last Update Posted (Actual)
February 12, 2018
Last Update Submitted That Met QC Criteria
February 9, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN2211-3772
- U1111-1120-7575 (Other Identifier: WHO)
- JapicCTI-111559 (Registry Identifier: JAPIC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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