NCT02200666

Brief Summary

The purpose of the investigation is to confirm the following under the post-marketing actual use of Forxiga Tablets (hereinafter referred to as Forxiga)

  • Development of ADRs specified as Key Investigation Items and the risk factors
  • Contributing factors possibly having an impact on the safety and efficacy
  • Development of ADRs unexpected from the Precautions for use and ADRs under actual drug use

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,793

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

47 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

First Submitted

Initial submission to the registry

July 24, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 3, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

4.9 years

First QC Date

July 24, 2014

Last Update Submit

February 21, 2020

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitusDiabetesForxigaLong-term use

Outcome Measures

Primary Outcomes (1)

  • Adverse event incidence

    from baseline to 3 years

Eligibility Criteria

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

Patients treated with Forxiga for the first time due to type 2 diabetes mellitus, which is the indication of the drug.

You may qualify if:

  • Patients treated with Forxiga for the first time due to type 2 diabetes mellitus, which is the indication of the drug.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Research Site

Aichi, D1692C00014, Japan

Location

Research Site

Akita, D1692C00014, Japan

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Aomori, D1692C00014, Japan

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Chiba, D1692C00014, Japan

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Ehime, D1692C00014, Japan

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Fukui, D1692C00014, Japan

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Fukuoka, D1692C00014, Japan

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Fukushima, D1692C00014, Japan

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Gifu, D1692C00014, Japan

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Gunma, D1692C00014, Japan

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Hiroshima, D1692C00014, Japan

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Hokkaido, D1692C00014, Japan

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Hyōgo, D1692C00014, Japan

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Ibaraki, D1692C00014, Japan

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Ishikawa, D1692C00014, Japan

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Kagawa, D1692C00014, Japan

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Kagoshima, D1692C00014, Japan

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Kanagawa, D1692C00014, Japan

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Kochi, D1692C00014, Japan

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Kumamoto, D1692C00014, Japan

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Kyoto, D1692C00014, Japan

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Mie, D1692C00014, Japan

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Miyagi, D1692C00014, Japan

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Miyazaki, D1692C00014, Japan

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Nagano, D1692C00014, Japan

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Nagasaki, D1692C00014, Japan

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Nara, D1692C00014, Japan

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Niigata, D1692C00014, Japan

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Numakunai, D1692C00014, Japan

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Okayama, D1692C00014, Japan

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Okinawa, D1692C00014, Japan

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Osaka, D1692C00014, Japan

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Ōita, D1692C00014, Japan

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Saga, D1692C00014, Japan

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Saitama, D1692C00014, Japan

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Shiga, D1692C00014, Japan

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Shimane, D1692C00014, Japan

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Shizuoka, D1692C00014, Japan

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Tochigi, D1692C00014, Japan

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Tokushima, D1692C00014, Japan

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Tokyo, D1692C00014, Japan

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Tottori, D1692C00014, Japan

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Toyama, D1692C00014, Japan

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Wakayama, D1692C00014, Japan

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Yamagata, D1692C00014, Japan

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Yamaguchi, D1692C00014, Japan

Location

Research Site

Yamanashi, D1692C00014, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 25, 2014

Study Start

October 3, 2014

Primary Completion

September 9, 2019

Study Completion

September 9, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

JP(47)