NCT02479399

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,412

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

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

July 17, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2018

Completed
Last Updated

October 22, 2024

Status Verified

December 1, 2018

Enrollment Period

4.3 years

First QC Date

June 15, 2015

Last Update Submit

October 19, 2024

Conditions

Type 2 Diabetes

Keywords

SuglatSGLT-2 inhibitorIpragliflozin L-ProlineASP1941 long-term use

Outcome Measures

Primary Outcomes (2)

  • Incidence of cardiovascular adverse events

    Up to 3 years

  • Incidence of malignant tumor

    Up to 3 years

Secondary Outcomes (1)

  • Safety developed by adverse events and laboratory tests

    Up to 3 years

Study Arms (1)

Suglat group

Tablets

Drug: ipragliflozin

Interventions

ipragliflozinDRUG

Tablets

Also known as: ASP1941, Suglat
Suglat group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

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

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Related Publications (5)

  • 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.

    PMID: 34567926DERIVED

  • 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.

    PMID: 33730336DERIVED

  • 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.

    PMID: 31347926DERIVED

  • 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.

    PMID: 30767112DERIVED

  • 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.

    PMID: 27463414DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ipragliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Medical Director

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 24, 2015

Study Start

July 17, 2014

Primary Completion

October 16, 2018

Study Completion

October 16, 2018

Last Updated

October 22, 2024

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Locations

JP(8)