- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02200666
Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use
February 21, 2020 updated by: AstraZeneca
The purpose of the investigation is to confirm the following under the post-marketing actual use of Forxiga Tablets (hereinafter referred to as Forxiga)
- Development of ADRs specified as Key Investigation Items and the risk factors
- Contributing factors possibly having an impact on the safety and efficacy
- Development of ADRs unexpected from the Precautions for use and ADRs under actual drug use
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
7793
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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Aichi, Japan, D1692C00014
- Research Site
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Akita, Japan, D1692C00014
- Research Site
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Aomori, Japan, D1692C00014
- Research Site
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Chiba, Japan, D1692C00014
- Research Site
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Ehime, Japan, D1692C00014
- Research Site
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Fukui, Japan, D1692C00014
- Research Site
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Fukuoka, Japan, D1692C00014
- Research Site
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Fukushima, Japan, D1692C00014
- Research Site
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Gifu, Japan, D1692C00014
- Research Site
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Gunma, Japan, D1692C00014
- Research Site
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Hiroshima, Japan, D1692C00014
- Research Site
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Hokkaido, Japan, D1692C00014
- Research Site
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Hyogo, Japan, D1692C00014
- Research Site
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Ibaraki, Japan, D1692C00014
- Research Site
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Ishikawa, Japan, D1692C00014
- Research Site
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Iwate, Japan, D1692C00014
- Research Site
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Kagawa, Japan, D1692C00014
- Research Site
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Kagoshima, Japan, D1692C00014
- Research Site
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Kanagawa, Japan, D1692C00014
- Research Site
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Kochi, Japan, D1692C00014
- Research Site
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Kumamoto, Japan, D1692C00014
- Research Site
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Kyoto, Japan, D1692C00014
- Research Site
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Mie, Japan, D1692C00014
- Research Site
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Miyagi, Japan, D1692C00014
- Research Site
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Miyazaki, Japan, D1692C00014
- Research Site
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Nagano, Japan, D1692C00014
- Research Site
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Nagasaki, Japan, D1692C00014
- Research Site
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Nara, Japan, D1692C00014
- Research Site
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Niigata, Japan, D1692C00014
- Research Site
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Oita, Japan, D1692C00014
- Research Site
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Okayama, Japan, D1692C00014
- Research Site
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Okinawa, Japan, D1692C00014
- Research Site
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Osaka, Japan, D1692C00014
- Research Site
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Saga, Japan, D1692C00014
- Research Site
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Saitama, Japan, D1692C00014
- Research Site
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Shiga, Japan, D1692C00014
- Research Site
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Shimane, Japan, D1692C00014
- Research Site
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Shizuoka, Japan, D1692C00014
- Research Site
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Tochigi, Japan, D1692C00014
- Research Site
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Tokushima, Japan, D1692C00014
- Research Site
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Tokyo, Japan, D1692C00014
- Research Site
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Tottori, Japan, D1692C00014
- Research Site
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Toyama, Japan, D1692C00014
- Research Site
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Wakayama, Japan, D1692C00014
- Research Site
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Yamagata, Japan, D1692C00014
- Research Site
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Yamaguchi, Japan, D1692C00014
- Research Site
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Yamanashi, Japan, D1692C00014
- Research 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
Patients treated with Forxiga for the first time due to type 2 diabetes mellitus, which is the indication of the drug.
Description
Inclusion Criteria:
Patients treated with Forxiga for the first time due to type 2 diabetes mellitus, which is the indication of the drug.
Exclusion Criteria:
N/A
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse event incidence
Time Frame: from baseline to 3 years
|
from baseline to 3 years
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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)
October 3, 2014
Primary Completion (Actual)
September 9, 2019
Study Completion (Actual)
September 9, 2019
Study Registration Dates
First Submitted
July 24, 2014
First Submitted That Met QC Criteria
July 24, 2014
First Posted (Estimate)
July 25, 2014
Study Record Updates
Last Update Posted (Actual)
February 25, 2020
Last Update Submitted That Met QC Criteria
February 21, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1692C00014
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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