- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02297620
The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients (STELLA-ELDER)
October 14, 2015 updated by: Astellas Pharma Inc
Specified Drug Use resulTs survEy of IpragLifLozin treAtment in ELDERly type2 Diabetes Patients (STELLA-ELDER)
The objective of this survey is to confirm the safety of Suglat Tablets when used in the elderly.
Study Overview
Detailed Description
Elderly patients (65 years or older at the time of first administration) with type 2 diabetes who used Suglat Tablets within 3 months from its launch are included in this study. Followings are measured with the patients.
- Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors.
- Investigate the occurrence of urinary tract infection.
- Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc).
- Investigate the occurrence of adverse drug reactions other than the above.
- Factors that may possibly influence the safety of Suglat Tablets.
Study Type
Observational
Enrollment (Actual)
8687
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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Chubu, Japan
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Chugoku, Japan
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Hokkaido, Japan
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Kansai, Japan
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Kantou, Japan
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Kyusyu, Japan
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Shikoku, Japan
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Tohoku, Japan
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Elderly patients with type 2 diabetes who used Suglat Tablets within 3 months from its launch
Description
Inclusion Criteria:
- type 2 diabetes who used Suglat Tablets within 3 months from its launch
Exclusion Criteria:
- off-label use patients
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Suglat group
|
oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors
Time Frame: Up to 12 months
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Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Investigate the occurrence of urinary tract infection
Time Frame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
|
1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
|
Investigate the occurrence of adverse drug reactions in patients at a high risk (those who have poorly controlled blood sugar levels, concurrent organic abnormalities in the urinary system, advanced diabetic neuropathy, etc).
Time Frame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
|
1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
|
Investigate the occurrence of adverse drug reactions other than the above
Time Frame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
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1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
|
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.
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
April 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
November 14, 2014
First Submitted That Met QC Criteria
November 19, 2014
First Posted (Estimate)
November 21, 2014
Study Record Updates
Last Update Posted (Estimate)
October 15, 2015
Last Update Submitted That Met QC Criteria
October 14, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGL001
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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