Specified Drug Use Results Survey of Ipragliflozin Treatment in type2 Diabetes Patients

NCT ID: NCT02479399

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

11412 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-17

Study Completion Date

2018-10-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Suglat group

Tablets

ipragliflozin

Intervention Type DRUG

Tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ipragliflozin

Tablets

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ASP1941 Suglat

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chugoku, , Japan

Site Status

Chūbu, , Japan

Site Status

Hokkaido, , Japan

Site Status

Kansai, , Japan

Site Status

Kantou, , Japan

Site Status

Kyushu, , Japan

Site Status

Shikoku, , Japan

Site Status

Tōhoku, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34567926 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33730336 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31347926 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30767112 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27463414 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SGL002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.