The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients
STELLA-ELDER
Specified Drug Use resulTs survEy of IpragLifLozin treAtment in ELDERly type2 Diabetes Patients (STELLA-ELDER)
1 other identifier
observational
8,687
1 country
8
Brief Summary
The objective of this survey is to confirm the safety of Suglat Tablets when used in the elderly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2014
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 14, 2014
CompletedFirst Posted
Study publicly available on registry
November 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 15, 2015
October 1, 2015
1.2 years
November 14, 2014
October 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors
Up to 12 months
Secondary Outcomes (3)
Investigate the occurrence of urinary tract infection
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).
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
1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
Study Arms (1)
Suglat group
Interventions
Eligibility Criteria
Elderly patients with type 2 diabetes who used Suglat Tablets within 3 months from its launch
You may qualify if:
- type 2 diabetes who used Suglat Tablets within 3 months from its launch
You may not qualify if:
- off-label use patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Chugoku, Japan
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kantou, Japan
Unknown Facility
Kyusyu, Japan
Unknown Facility
Shikoku, Japan
Unknown Facility
Tōhoku, Japan
Related Publications (1)
Terauchi Y, Yokote K, Nakamura I, Sugamori H. Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): Interim results of a post-marketing surveillance study. Expert Opin Pharmacother. 2016;17(4):463-71. doi: 10.1517/14656566.2016.1145668. Epub 2016 Feb 5.
PMID: 26800061DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2014
First Posted
November 21, 2014
Study Start
April 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
October 15, 2015
Record last verified: 2015-10