Clinical trial NCT02479399: Specified Drug Use Results Survey of Ipragliflozin Treatment in type2 Diabetes Patients
Official title: Specified Drug Use resulTs survEy of lpragLifLozin treAtment in type2 Diabetes Patients: LONG-TERM (STELLA-LONG TERM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Suglat
SGLT-2 inhibitor
Ipragliflozin L-Proline
ASP1941 long-term use
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 11412
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes who first use Suglat Tablets during the period from July 17, 2014 to July 16, 2015

Brief summary: The objective of this survey is to confirm the safety of Suglat Tablets

Detailed description: The objective of this survey is to confirm the safety and efficacy of Suglat Tablets for long-term use over 3 years.

Specify the effects of Suglat Tablets on the cardiovascular system, incidence rates of malignant tumor, and their risk factors.

Investigate the occurrence of adverse drug reactions. Specify factors that may possibly influence the safety and efficacy of Suglat Tablets.

\<Items of interest\>

* Hypoglycemia
* Genital infection
* Urinary tract infection
* Polyuria and pollakiuria
* Adverse events related to a decrease in body fluids (dehydration, etc.)
* Malignant tumor
* Cardiovascular diseases

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes who first use Suglat Tablets during the period from July 17, 2014 to July 16, 2015

Exclusion Criteria:

* off-label use patients

Primary outcomes:
measure: Incidence of cardiovascular adverse events
timeFrame: Up to 3 years
measure: Incidence of malignant tumor
timeFrame: Up to 3 years
Secondary outcomes:
measure: Safety developed by adverse events and laboratory tests
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Tohoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Maegawa H, Tobe K, Nakamura I, Uno S. Real-world evidence for long-term safety and effectiveness of ipragliflozin in treatment-naive versus non-naive Japanese patients with type 2 diabetes mellitus: subgroup analysis of a 3-year post-marketing surveillance study (STELLA-LONG TERM). Diabetol Int. 2021 Mar 24;12(4):430-444. doi: 10.1007/s13340-021-00501-w. eCollection 2021 Oct.
citation: Nakamura I, Maegawa H, Tobe K, Uno S. Safety and Effectiveness of Ipragliflozin in Elderly Versus Non-elderly Japanese Patients with Type 2 Diabetes: Subgroup Analysis of STELLA-LONG TERM. Diabetes Ther. 2021 May;12(5):1359-1378. doi: 10.1007/s13300-021-01042-w. Epub 2021 Mar 17.
citation: Maegawa H, Tobe K, Nakamura I, Uno S. Safety and effectiveness of ipragliflozin in elderly versus non-elderly Japanese type 2 diabetes mellitus patients: 12 month interim results of the STELLA-LONG TERM study. Curr Med Res Opin. 2019 Nov;35(11):1901-1910. doi: 10.1080/03007995.2019.1647503. Epub 2019 Aug 29.
citation: Nakamura I, Maegawa H, Tobe K, Uno S. Safety and Effectiveness of Ipragliflozin for Type 2 Diabetes in Japan: 12-Month Interim Results of the STELLA-LONG TERM Post-Marketing Surveillance Study. Adv Ther. 2019 Apr;36(4):923-949. doi: 10.1007/s12325-019-0895-1. Epub 2019 Feb 14.
citation: Maegawa H, Tobe K, Tabuchi H, Nakamura I. Baseline characteristics and interim (3-month) efficacy and safety data from STELLA-LONG TERM, a long-term post-marketing surveillance study of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice. Expert Opin Pharmacother. 2016 Oct;17(15):1985-94. doi: 10.1080/14656566.2016.1217994. Epub 2016 Aug 12.