Clinical trial NCT02297620: The Survey of Ipragliflozin Treatment in Elderly type2 Diabetes Patients
Official title: Specified Drug Use resulTs survEy of IpragLifLozin treAtment in ELDERly type2 Diabetes Patients (STELLA-ELDER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: SGLT-2 inhibitor
Elderly patients
ASP1941
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-11-21
Enrollment: 8687
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with type 2 diabetes who used Suglat Tablets within 3 months from its launch

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* off-label use patients

Primary outcomes:
measure: Specify incidence rates of adverse drug reactions associated with a decrease in body fluids and their risk factors
timeFrame: Up to 12 months
Secondary outcomes:
measure: Investigate the occurrence of urinary tract infection
timeFrame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
measure: 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).
timeFrame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
measure: Investigate the occurrence of adverse drug reactions other than the above
timeFrame: 1-month, 3-month, 6-month, 9-month and 12-month (or at treatment discontinuation time)
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
city: Shikoku
country: Japan
city: Tohoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.