Forxiga Tablets Specific Clinical Experience Investigation for Elderly

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02200627

Enrollment

1724

Registered

2014-07-25

Start date

2014-09-30

Completion date

2016-04-30

Last updated

2017-02-23

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, Elderly

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) in elderly patients. * 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

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Patients treated with Forxiga for the first time during three months after the launch due to type 2 diabetes mellitus, which is the indication of the drug, aged 65 or over at the time when Forxiga was started. In addition, patients receiving the study drug of Forxiga before the launch should be included also.

Exclusion criteria

N/A

Design outcomes

Primary

Measure	Time frame
Adverse event incidence	from baseline to 1 year

Countries

Japan

Outcome results