Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02200666

Enrollment

7793

Registered

2014-07-25

Start date

2014-10-03

Completion date

2019-09-09

Last updated

2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus, Diabetes, Forxiga, Long-term use

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

N/A

Design outcomes

Primary

Measure	Time frame
Adverse event incidence	from baseline to 3 years

Countries

Japan

Outcome results