The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients

Specified Drug Use resulTs survEy of IpragLifLozin treAtment in ELDERly type2 Diabetes Patients (STELLA-ELDER)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02297620

Acronym

STELLA-ELDER

Enrollment

8687

Registered

2014-11-21

Start date

2014-04-30

Completion date

2015-07-31

Last updated

2015-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

SGLT-2 inhibitor, Elderly patients, ASP1941

Brief summary

The objective of this survey is to confirm the safety of Suglat Tablets when used in the elderly.

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. 1. Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors. 2. Investigate the occurrence of urinary tract infection. 3. 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). 4. Investigate the occurrence of adverse drug reactions other than the above. 5. Factors that may possibly influence the safety of Suglat Tablets.

Interventions

DRUGSuglat®

oral

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* type 2 diabetes who used Suglat Tablets within 3 months from its launch

Exclusion criteria

* off-label use patients

Design outcomes

Primary

Measure	Time frame
Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors	Up to 12 months

Secondary

Measure	Time frame
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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026